Psychological Support for Patients With an Implantable Cardioverter Defibrillator

• Sponsor: University Health Network, Toronto (Other)
• Overall Status: Completed
• CT.gov ID: NCT00152763
• Collaborator: (none)
• Enrollment: 193
• Location: 1
• Arms: 4
• Duration (Months): 49
• Patients Per Site Per Month: 3.9

Study Details

Study Description

Brief Summary

About 30% of patients survive a cardiac arrest, and the majority of these receive an implantable cardioverter defibrillator (ICD) for prevention of sudden cardiac death (SCD). While ICD therapy offers survival benefit over drug therapy, there remain significant quality of life (QL) issues. About 50% of patients experience chronic anxiety about receiving an ICD shock. Anxiety and depression in turn appear to predispose to more arrhythmias necessitating

ICD therapy. The aims of the current study are:

1. to evaluate a 8-session psychosocial intervention to help patients cope effectively with receiving an ICD for secondary prevention of SCD,

2. to determine if baseline measures of depression and anxiety predict ICD therapies (i.e., anti-tachycardia pace terminations and shocks); and

3. to explore if the psychosocial intervention results in less need for appropriate ICD therapies.

Condition or Disease	Intervention/Treatment	Phase
Anxiety; Depression	Behavioral: Cognitive Behaviour Therapy (CBT); Other: Usual Cardiac Care (UCC)	Phase 3

Detailed Description

About 30% of patients survive a cardiac arrest, and the majority of these receive an implantable cardioverter defibrillator (ICD) for prevention of sudden cardiac death (SCD). While ICD therapy offers survival benefit over drug therapy, there remain significant quality of life (QL) issues. About 50% of patients experience chronic anxiety about receiving an ICD shock. Anxiety and depression in turn appear to predispose to more arrhythmias necessitating

ICD therapy. The aims of the current study are:

1. to evaluate a 8-session psychosocial intervention to help patients cope effectively with receiving an ICD for secondary prevention of SCD,

2. to determine if baseline measures of depression and anxiety predict ICD therapies (i.e., anti-tachycardia pace terminations and shocks); and

3. to explore if the psychosocial intervention results in less need for appropriate ICD therapies.

This study will randomize 218 ICD patients to receive either usual cardiac care (n=109) OR usual cardiac care plus CBT (n=109). Participants are recruited from two hospitals in Toronto that perform ICD implants (St. Michael's Hospital and the Toronto General Hospital). Counselling follows a CBT manual and involves both face-to-face sessions and telephone sessions. The telephone is employed as a means to deliver therapy as at least half of our ICD subjects reside outside of Toronto and all patients are prohibited from driving an automobile for the first six months following ICD implant. Outcome is assessed 6 and 12-months following the date of randomization and include measures of psychological function and quality of life. Secondary outcome is frequency of ICD therapies over follow-up (i.e., anti-tachycardia pacing terminations and DC shocks).

Inclusion Criteria:

• Patients from either Toronto General hospital or St. Michael's Hospital who have coronary heart disease,

• Receiving their first ICD implant for secondary prevention of SCD or primary prevention of SCD if their underlying heart disease was hypertrophic cardiomyopathy.

Exclusion Criteria:

• Not able to read or understand English;

• Evidence of psychosis, dementia or cognitive impairment as documented in the patients' hospital records;

• Receiving an ICD for primary prevention of ICD.

Study Design

• Study Type: Interventional
• Actual Enrollment: 193 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Psychological Support for Patients With an Implantable Cardioverter Defibrillator
• Study Start Date: Oct 1, 2003
• Actual Primary Completion Date: Sep 1, 2007
• Actual Study Completion Date: Nov 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cognitive Behavior Therapy - males Eight telephone sessions of cognitive behavior therapy tailored to psychological adaptation to an ICD, plus a psycho-educational booklet for participants and a therapist manual. This arm included the males.	Behavioral: Cognitive Behaviour Therapy (CBT); Cognitive behavior therapy tailored to psychological adaptation to an ICD, included 8 telephone counselling sessions, plus psycho-educational booklet and a therapist manual.
Experimental: Cognitive Behavior Therapy - females Eight telephone sessions of cognitive behavior therapy tailored to psychological adaptation to an ICD, plus a psycho-educational booklet for participants and a therapist manual. This arm included the females.	Behavioral: Cognitive Behaviour Therapy (CBT); Cognitive behavior therapy tailored to psychological adaptation to an ICD, included 8 telephone counselling sessions, plus psycho-educational booklet and a therapist manual.
Active Comparator: Usual Cardiac Care - Males The UCC was defined as whatever the respective ICD treatment sites routinely offer their patients. All patients received standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed. This arm was just for males randomized.	Other: Usual Cardiac Care (UCC); Usual cardiac care (UCC) was defined as whatever the respective ICD treatment sites routinely offer their patients. All patients received standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
Active Comparator: Usual Cardiac Care - females The UCC was defined as whatever the respective ICD treatment sites routinely offer their patients. All patients received standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed. This arm was for females randomized.	Other: Usual Cardiac Care (UCC); Usual cardiac care (UCC) was defined as whatever the respective ICD treatment sites routinely offer their patients. All patients received standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.

Outcome Measures

Primary Outcome Measures

1. Hospital Anxiety and Depression Scale - Depression Scale at Baseline [Baseline]

   Psychometric scale measuring symptoms of depression, score range is 0 to 24. Scores >= 8 represent clinically elevated scores. Higher scores represent greater depressive symptoms.

2. Hospital Anxiety and Depression Scale - Depression Scale at 6-months Follow-up [Six-months follow-up]

   Psychometric scale measuring symptoms of depression, score range is 0 to 24. Scores >= 8 represent clinically elevated scores. Higher scores represent greater depressive symptoms.

3. Hospital Anxiety and Depression Scale - Depression Scale at 12-months Follow-up [Twelve-months follow-up]

   Psychometric scale measuring symptoms of depression, score range is 0 to 24. Scores >= 8 represent clinically elevated scores. Higher scores represent greater depressive symptoms.

4. Hospital Anxiety and Depression Scale - Anxiety Scale at Baseline [Baseline]

   Psychometric scale measuring symptoms of anxiety,score range is 0 to 24. Scores >= 8 represent clinically elevated scores. Higher scores represent greater anxiety symptoms.

5. Hospital Anxiety and Depression Scale - Anxiety Scale at 6-months Follow-up [Six-months follow-up]

   Psychometric scale measuring symptoms of anxiety,score range is 0 to 24. Scores >= 8 represent clinically elevated scores. Higher scores represent greater anxiety symptoms.

6. Hospital Anxiety and Depression Scale - Anxiety Scale at 12-months Follow-up [Twelve-months follow-up]

   Psychometric scale measuring symptoms of anxiety,score range is 0 to 24. Scores >= 8 represent clinically elevated scores. Higher scores represent greater anxiety symptoms.

7. Impact of Events Scale-Revised - Total Score at Baseline [Baseline]

   Psychometric measure of post traumatic stress disorder symptoms, scores range from 0 to 4. A score threshold of 1.4 has been found to diagnostic of post traumatic stress disorder in war veterans. Higher scores represent greater total post traumatic stress disorder symptoms.

8. Impact of Events Scale-Revised - Total Score at 6-months Follow-up [Six-months follow-up]

   Psychometric measure of post traumatic stress disorder symptoms, scores range from 0 to 4. A score threshold of 1.4 has been found to diagnostic of post traumatic stress disorder in war veterans. Higher scores represent greater total post traumatic stress disorder symptoms.

9. Impact of Events Scale-Revised - Total Score at 12-months Follow-up [Twelve-months follow-up]

   Psychometric measure of post traumatic stress disorder symptoms, scores range from 0 to 4. A score threshold of 1.4 has been found to diagnostic of post traumatic stress disorder in war veterans. Higher scores represent greater total post traumatic stress disorder symptoms.

10. Impact of Events Scale-Revised - Intrusiveness Scale at Baseline [Baseline]

    Psychometric measure of post traumatic stress disorder intrusiveness symptoms, scores range from 0 to 4. Higher scores represent greater post traumatic stress disorder intrusiveness symptoms.

11. Impact of Events Scale-Revised - Intrusiveness Scale at 6-months Follow-up [Six-months follow-up]

    Psychometric measure of post traumatic stress disorder intrusiveness symptoms, scores range from 0 to 4. Higher scores represent greater post traumatic stress disorder intrusiveness symptoms.

12. Impact of Events Scale-Revised - Intrusiveness Scale at 12-months Follow-up [Twelve-months follow-up]

    Psychometric measure of post traumatic stress disorder intrusiveness symptoms, scores range from 0 to 4. Higher scores represent greater post traumatic stress disorder intrusiveness symptoms.

13. Impact of Events Scale-Revised - Avoidance Scale at Baseline [Baseline]

    Psychometric assessment of post traumatic stress disorder avoidance symptoms, scores range from 0 to 4. Higher scores represent greater post traumatic stress disorder avoidance symptoms.

14. Impact of Events Scale-Revised - Avoidance Scale at 6-months Follow-up [Six-months follow-up]

    Psychometric assessment of post traumatic stress disorder avoidance symptoms, scores range from 0 to 4. Higher scores represent greater post traumatic stress disorder avoidance symptoms.

15. Impact of Events Scale-Revised - Avoidance Scale at 12-months Follow-up [Twelve-months follow-up]

    Psychometric assessment of post traumatic stress disorder avoidance symptoms, scores range from 0 to 4. Higher scores represent greater post traumatic stress disorder avoidance symptoms.

16. Impact of Event Scale-Revised Hyperarousal Scale at Baseline [Baseline]

    Psychometric measure of post traumatic stress disorder hyper-arousal symptoms, scores range from 0 to 4. Higher scores represent greater post traumatic stress disorder hyperarousal symptoms.

17. Impact of Event Scale-Revised Hyperarousal Scale at 6-months Follow-up [Six-months follow-up]

    Psychometric measure of post traumatic stress disorder hyper-arousal symptoms, scores range from 0 to 4. Higher scores represent greater post traumatic stress disorder hyperarousal symptoms.

18. Impact of Event Scale-Revised Hyperarousal Scale at 12-months Follow-up [Twelve-months follow-up]

    Psychometric measure of post traumatic stress disorder hyper-arousal symptoms, scores range from 0 to 4. Higher scores represent greater post traumatic stress disorder hyperarousal symptoms.

19. Crown-Crisp Experiential Index - Phobic Anxiety Scale at Baseline [Baseline]

    Psychometric measure of phobic anxiety, scores range from 1 to 3. Higher scores represent greater phobic anxiety symptoms.

20. Crown-Crisp Experiential Index - Phobic Anxiety Scale at 6-months Follow-up [Six-months follow-up]

    Psychometric measure of phobic anxiety, scores range from 1 to 3. Higher scores represent greater phobic anxiety symptoms.

21. Crown-Crisp Experiential Index - Phobic Anxiety Scale at 12-months Follow-up [Twelve-months follow-up]

    Psychometric measure of phobic anxiety, scores range from 1 to 3. Higher scores represent greater phobic anxiety symptoms.

Secondary Outcome Measures

1. SF-36 Mental Component Summary Scale at Baseline [Baseline]

   Quality of life measure - mental health summary, scores range from 0 to 100 with higher scores representing better mental health.

2. SF-36 Mental Component Summary Scale at 6-months Follow-up [Six-months follow-up]

   Quality of life measure - mental health summary, scores range from 0 to 100 with higher scores representing better mental health.

3. SF-36 Mental Component Summary Scale at 12-months Follow-up [Twelve-months follow-up]

   Quality of life measure - mental health summary, scores range from 0 to 100 with higher scores representing better mental health.

4. SF-36 Physical Component Summary Score at Baseline [Baseline]

   Quality of life measure of physical health, scores range from 0 to 100 with higher scores representing better physical health.

5. SF-36 Physical Component Summary Score at 6-months Follow-up [Six-months follow-up]

   Quality of life measure of physical health, scores range from 0 to 100 with higher scores representing better physical health.

6. SF-36 Physical Component Summary Score at 12-months Follow-up [Twelve-months follow-up]

   Quality of life measure of physical health, scores range from 0 to 100 with higher scores representing better physical health.

7. Percentage of Participants Who Received ICD Therapies [12-months follow-up]

   Percentage of participants who received ICD shocks or anti-tachycardia therapies, data extracted from participants ICD devices over follow-up.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients from either Toronto General hospital or St. Michael's Hospital who have coronary heart disease,

• Receiving their first ICD implant for secondary prevention of SCD or for primary prevention of SCD and their underlying heart disease was hypertrophic cardiomyopathy.

Exclusion Criteria:

• Not able to read or understand English;

• Evidence of psychosis, dementia or cognitive impairment as documented in the patients' hospital records;

• Receiving an ICD for primary prevention of ICD.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Toronto General Hospital	Toronto	Ontario	Canada	M5G 2C4

Sponsors and Collaborators

• University Health Network, Toronto

Investigators

• Principal Investigator: Jane Irvine, D.Phil., University Health Network, Toronto General Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

• Irvine, J. Stanley, J., Ong, L., Cribbie, R., Ritvo, P., Katz, J., Dorian, P., O'Donnell, S., Harris, L., Cameron, D., Hill, A., Newman, D., Johnson, S. N., Bilanovic, A. Sears, S F. Acceptability of a Cognitive Behavior Therapy Intervention to Implantable Cardioverter Defibrillator Recipients, Journal of Cognitive Psychotherapy, 2010; 24(4) (November), 243-264.

• ClinicalTrials.gov Identifier: NCT00152763
• Other Study ID Numbers: NA 5170; Grant number NA 5170
• First Posted: Sep 9, 2005
• Last Update Posted: Jan 28, 2011
• Last Verified: Jan 1, 2011

• Keywords provided by , ,: health anxiety
• Additional relevant MeSH terms: Depression

Study Results

Participant Flow

Recruitment Details	Recruitment commenced in October 2003 at Toronto General Hospital and St. Michael's Hospital in Toronto, Ontario, Canada and concluded in August 2006.
Pre-assignment Detail	Upon recruitment, participants completed baseline psychological assessment prior to being randomized to the experimental intervention arm (cognitive behaviour therapy) or usual care.

Arm/Group Title	Usual Cardiac Care - Men	Cognitive Behaviour Therapy - Women	Usual Cardiac Care - Women	Cognitive Therapy Group - Men
Arm/Group Description	Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.	Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet	Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.	Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
Period Title: Overall Study
STARTED	77	19	20	77
COMPLETED	67	14	16	63
NOT COMPLETED	10	5	4	14

Baseline Characteristics

Arm/Group Title	Usual Cardiac Care - Men	Cognitive Behaviour Therapy - Women	Usual Cardiac Care - Women	Cognitive Therapy Group - Men	Total
Arm/Group Description	Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.	Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet	Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.	Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.	Total of all reporting groups
Overall Participants	77	19	20	77	193
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	61.29 (13.17)	54.58 (15.75)	55.35 (18.30)	64.2 (13.35)	61.68 (14.18)
Sex: Female, Male (Count of Participants)
Female	0 0%	19 100%	20 100%	0 0%	39 20.2%
Male	77 100%	0 0%	0 0%	77 100%	154 79.8%

Outcome Measures

1. Primary Outcome

Title	Hospital Anxiety and Depression Scale - Depression Scale at Baseline
Description	Psychometric scale measuring symptoms of depression, score range is 0 to 24. Scores >= 8 represent clinically elevated scores. Higher scores represent greater depressive symptoms.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

Intention to treat analyses but data on participants who died over follow-up were omitted.

Arm/Group Title	Usual Cardiac Care - Men	Cognitive Behaviour Therapy - Women	Usual Cardiac Care - Women	Cognitive Therapy Group - Men
Arm/Group Description	Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.	Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet	Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.	Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
Measure Participants	73	18	16	76
Mean (Standard Deviation) [units on a scale]	4.70 (3.41)	7.47 (5.02)	5.35 (3.82)	4.12 (4.01)

2. Secondary Outcome

Title	SF-36 Mental Component Summary Scale at Baseline
Description	Quality of life measure - mental health summary, scores range from 0 to 100 with higher scores representing better mental health.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Usual Cardiac Care - Men	Cognitive Behaviour Therapy - Women	Usual Cardiac Care - Women	Cognitive Therapy Group - Men
Arm/Group Description	Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.	Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet	Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.	Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
Measure Participants	73	18	16	76
Mean (Standard Deviation) [units on a scale]	45.90 (13.40)	37.44 (13.69)	42.33 (12.43)	49.84 (10.56)

3. Primary Outcome

Title	Hospital Anxiety and Depression Scale - Depression Scale at 6-months Follow-up
Description	Psychometric scale measuring symptoms of depression, score range is 0 to 24. Scores >= 8 represent clinically elevated scores. Higher scores represent greater depressive symptoms.
Time Frame	Six-months follow-up

Outcome Measure Data

Analysis Population Description

Intention to treat analyses but data on participants who died over follow-up were omitted.

Arm/Group Title	Usual Cardiac Care - Men	Cognitive Behaviour Therapy - Women	Usual Cardiac Care - Women	Cognitive Therapy Group - Men
Arm/Group Description	Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.	Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet	Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.	Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
Measure Participants	73	18	16	76
Mean (Standard Deviation) [units on a scale]	4.21 (3.31)	4.86 (3.25)	5.50 (4.22)	3.82 (3.39)

4. Secondary Outcome

Title	SF-36 Mental Component Summary Scale at 6-months Follow-up
Description	Quality of life measure - mental health summary, scores range from 0 to 100 with higher scores representing better mental health.
Time Frame	Six-months follow-up

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Usual Cardiac Care - Men	Cognitive Behaviour Therapy - Women	Usual Cardiac Care - Women	Cognitive Therapy Group - Men
Arm/Group Description	Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.	Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet	Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.	Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
Measure Participants	73	18	16	76
Mean (Standard Deviation) [units on a scale]	48.73 (10.34)	43.82 (11.64)	45.67 (10.84)	51.32 (10.99)

5. Primary Outcome

Title	Hospital Anxiety and Depression Scale - Depression Scale at 12-months Follow-up
Description	Psychometric scale measuring symptoms of depression, score range is 0 to 24. Scores >= 8 represent clinically elevated scores. Higher scores represent greater depressive symptoms.
Time Frame	Twelve-months follow-up

Outcome Measure Data

Analysis Population Description

Intention to treat analyses but data on participants who died over follow-up were omitted.

Arm/Group Title	Usual Cardiac Care - Men	Cognitive Behaviour Therapy - Women	Usual Cardiac Care - Women	Cognitive Therapy Group - Men
Arm/Group Description	Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.	Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet	Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.	Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
Measure Participants	73	18	16	76
Mean (Standard Deviation) [units on a scale]	4.52 (3.29)	4.67 (4.19)	5.87 (3.12)	4.15 (3.36)

6. Primary Outcome

Title	Hospital Anxiety and Depression Scale - Anxiety Scale at Baseline
Description	Psychometric scale measuring symptoms of anxiety,score range is 0 to 24. Scores >= 8 represent clinically elevated scores. Higher scores represent greater anxiety symptoms.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

Intention to treat analyses but data on participants who died over follow-up were omitted.

Arm/Group Title	Usual Cardiac Care - Men	Cognitive Behaviour Therapy - Women	Usual Cardiac Care - Women	Cognitive Therapy Group - Men
Arm/Group Description	Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.	Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet	Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.	Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
Measure Participants	73	18	16	76
Mean (Standard Deviation) [units on a scale]	6.53 (4.26)	9.32 (5.50)	7.70 (3.85)	4.80 (3.93)

7. Primary Outcome

Title	Hospital Anxiety and Depression Scale - Anxiety Scale at 6-months Follow-up
Description	Psychometric scale measuring symptoms of anxiety,score range is 0 to 24. Scores >= 8 represent clinically elevated scores. Higher scores represent greater anxiety symptoms.
Time Frame	Six-months follow-up

Outcome Measure Data

Analysis Population Description

Intention to treat analyses but data on participants who died over follow-up were omitted.

Arm/Group Title	Usual Cardiac Care - Men	Cognitive Behaviour Therapy - Women	Usual Cardiac Care - Women	Cognitive Therapy Group - Men
Arm/Group Description	Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.	Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet	Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.	Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
Measure Participants	73	18	16	76
Mean (Standard Deviation) [units on a scale]	6.06 (3.84)	7.28 (4.01)	6.83 (4.67)	4.69 (3.92)

8. Primary Outcome

Title	Hospital Anxiety and Depression Scale - Anxiety Scale at 12-months Follow-up
Description	Psychometric scale measuring symptoms of anxiety,score range is 0 to 24. Scores >= 8 represent clinically elevated scores. Higher scores represent greater anxiety symptoms.
Time Frame	Twelve-months follow-up

Outcome Measure Data

Analysis Population Description

Intention to treat analyses but data on participants who died over follow-up were omitted.

Arm/Group Title	Usual Cardiac Care - Men	Cognitive Behaviour Therapy - Women	Usual Cardiac Care - Women	Cognitive Therapy Group - Men
Arm/Group Description	Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.	Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet	Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.	Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
Measure Participants	73	18	16	76
Mean (Standard Deviation) [units on a scale]	6.06 (3.97)	8.00 (3.70)	7.25 (3.57)	4.43 (3.77)

9. Primary Outcome

Title	Impact of Events Scale-Revised - Total Score at Baseline
Description	Psychometric measure of post traumatic stress disorder symptoms, scores range from 0 to 4. A score threshold of 1.4 has been found to diagnostic of post traumatic stress disorder in war veterans. Higher scores represent greater total post traumatic stress disorder symptoms.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

Intention to treat analysis although data for participants who died over follow-up were omitted.

Arm/Group Title	Usual Cardiac Care - Men	Cognitive Behaviour Therapy - Women	Usual Cardiac Care - Women	Cognitive Therapy Group - Men
Arm/Group Description	Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.	Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet	Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.	Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
Measure Participants	73	18	12	76
Mean (Standard Deviation) [units on a scale]	0.81 (0.66)	1.56 (0.99)	1.20 (0.85)	0.63 (0.51)

10. Secondary Outcome

Title	SF-36 Mental Component Summary Scale at 12-months Follow-up
Description	Quality of life measure - mental health summary, scores range from 0 to 100 with higher scores representing better mental health.
Time Frame	Twelve-months follow-up

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Usual Cardiac Care - Men	Cognitive Behaviour Therapy - Women	Usual Cardiac Care - Women	Cognitive Therapy Group - Men
Arm/Group Description	Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.	Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet	Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.	Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
Measure Participants	73	18	16	76
Mean (Standard Deviation) [units on a scale]	49.92 (10.50)	46.26 (14.00)	41.58 (9.02)	51.61 (46.26)

11. Primary Outcome

Title	Impact of Events Scale-Revised - Total Score at 6-months Follow-up
Description	Psychometric measure of post traumatic stress disorder symptoms, scores range from 0 to 4. A score threshold of 1.4 has been found to diagnostic of post traumatic stress disorder in war veterans. Higher scores represent greater total post traumatic stress disorder symptoms.
Time Frame	Six-months follow-up

Outcome Measure Data

Analysis Population Description

Intention to treat analysis although data for participants who died over follow-up were omitted.

Arm/Group Title	Usual Cardiac Care - Men	Cognitive Behaviour Therapy - Women	Usual Cardiac Care - Women	Cognitive Therapy Group - Men
Arm/Group Description	Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.	Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet	Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.	Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
Measure Participants	73	18	12	76
Mean (Standard Deviation) [units on a scale]	0.70 (0.52)	0.76 (0.83)	0.68 (0.64)	0.54 (0.62)

12. Primary Outcome

Title	Impact of Events Scale-Revised - Total Score at 12-months Follow-up
Description	Psychometric measure of post traumatic stress disorder symptoms, scores range from 0 to 4. A score threshold of 1.4 has been found to diagnostic of post traumatic stress disorder in war veterans. Higher scores represent greater total post traumatic stress disorder symptoms.
Time Frame	Twelve-months follow-up

Outcome Measure Data

Analysis Population Description

Intention to treat analysis although data for participants who died over follow-up were omitted.

Arm/Group Title	Usual Cardiac Care - Men	Cognitive Behaviour Therapy - Women	Usual Cardiac Care - Women	Cognitive Therapy Group - Men
Arm/Group Description	Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.	Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet	Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.	Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
Measure Participants	73	18	12	76
Mean (Standard Deviation) [units on a scale]	0.70 (0.64)	0.69 (0.53)	0.82 (0.69)	0.46 (0.47)

13. Primary Outcome

Title	Impact of Events Scale-Revised - Intrusiveness Scale at Baseline
Description	Psychometric measure of post traumatic stress disorder intrusiveness symptoms, scores range from 0 to 4. Higher scores represent greater post traumatic stress disorder intrusiveness symptoms.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Usual Cardiac Care - Men	Cognitive Behaviour Therapy - Women	Usual Cardiac Care - Women	Cognitive Therapy Group - Men
Arm/Group Description	Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.	Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet	Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.	Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
Measure Participants	73	18	16	76
Mean (Standard Deviation) [units on a scale]	0.80 (0.71)	1.53 (0.98)	1.25 (0.95)	0.61 (0.64)

14. Primary Outcome

Title	Impact of Events Scale-Revised - Intrusiveness Scale at 6-months Follow-up
Description	Psychometric measure of post traumatic stress disorder intrusiveness symptoms, scores range from 0 to 4. Higher scores represent greater post traumatic stress disorder intrusiveness symptoms.
Time Frame	Six-months follow-up

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Usual Cardiac Care - Men	Cognitive Behaviour Therapy - Women	Usual Cardiac Care - Women	Cognitive Therapy Group - Men
Arm/Group Description	Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.	Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet	Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.	Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
Measure Participants	73	18	16	76
Mean (Standard Deviation) [units on a scale]	0.61 (0.52)	0.82 (0.96)	0.73 (0.73)	0.56 (0.73)

15. Primary Outcome

Title	Impact of Events Scale-Revised - Intrusiveness Scale at 12-months Follow-up
Description	Psychometric measure of post traumatic stress disorder intrusiveness symptoms, scores range from 0 to 4. Higher scores represent greater post traumatic stress disorder intrusiveness symptoms.
Time Frame	Twelve-months follow-up

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Usual Cardiac Care - Men	Cognitive Behaviour Therapy - Women	Usual Cardiac Care - Women	Cognitive Therapy Group - Men
Arm/Group Description	Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.	Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet	Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.	Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
Measure Participants	73	18	16	76
Mean (Standard Deviation) [units on a scale]	0.62 (0.62)	0.64 (0.60)	0.80 (0.70)	0.42 (0.47)

16. Primary Outcome

Title	Impact of Events Scale-Revised - Avoidance Scale at Baseline
Description	Psychometric assessment of post traumatic stress disorder avoidance symptoms, scores range from 0 to 4. Higher scores represent greater post traumatic stress disorder avoidance symptoms.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

Intention to treat analysis although data from participants who died were omitted from analysis

Arm/Group Title	Usual Cardiac Care - Men	Cognitive Behaviour Therapy - Women	Usual Cardiac Care - Women	Cognitive Therapy Group - Men
Arm/Group Description	Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.	Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet	Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.	Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
Measure Participants	73	18	12	76
Mean (Standard Deviation) [units on a scale]	0.84 (0.62)	1.68 (1.10)	1.25 (0.82)	0.64 (0.58)

17. Primary Outcome

Title	Impact of Events Scale-Revised - Avoidance Scale at 6-months Follow-up
Description	Psychometric assessment of post traumatic stress disorder avoidance symptoms, scores range from 0 to 4. Higher scores represent greater post traumatic stress disorder avoidance symptoms.
Time Frame	Six-months follow-up

Outcome Measure Data

Analysis Population Description

Intention to treat analysis although data from participants who died were omitted from analysis

Arm/Group Title	Usual Cardiac Care - Men	Cognitive Behaviour Therapy - Women	Usual Cardiac Care - Women	Cognitive Therapy Group - Men
Arm/Group Description	Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.	Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet	Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.	Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
Measure Participants	73	18	12	76
Mean (Standard Deviation) [units on a scale]	0.86 (0.64)	0.77 (0.87)	0.74 (0.71)	0.55 (0.64)

18. Primary Outcome

Title	Impact of Events Scale-Revised - Avoidance Scale at 12-months Follow-up
Description	Psychometric assessment of post traumatic stress disorder avoidance symptoms, scores range from 0 to 4. Higher scores represent greater post traumatic stress disorder avoidance symptoms.
Time Frame	Twelve-months follow-up

Outcome Measure Data

Analysis Population Description

Intention to treat analysis although data from participants who died were omitted from analysis

Arm/Group Title	Usual Cardiac Care - Men	Cognitive Behaviour Therapy - Women	Usual Cardiac Care - Women	Cognitive Therapy Group - Men
Arm/Group Description	Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.	Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet	Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.	Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
Measure Participants	73	18	12	76
Mean (Standard Deviation) [units on a scale]	0.82 (0.74)	0.84 (0.65)	0.98 (0.86)	0.57 (0.66)

19. Primary Outcome

Title	Impact of Event Scale-Revised Hyperarousal Scale at Baseline
Description	Psychometric measure of post traumatic stress disorder hyper-arousal symptoms, scores range from 0 to 4. Higher scores represent greater post traumatic stress disorder hyperarousal symptoms.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Usual Cardiac Care - Men	Cognitive Behaviour Therapy - Women	Usual Cardiac Care - Women	Cognitive Therapy Group - Men
Arm/Group Description	Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.	Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet	Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.	Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
Measure Participants	73	18	16	76
Mean (Standard Deviation) [units on a scale]	0.78 (0.86)	1.40 (1.11)	1.07 (0.98)	0.64 (0.67)

20. Primary Outcome

Title	Impact of Event Scale-Revised Hyperarousal Scale at 6-months Follow-up
Description	Psychometric measure of post traumatic stress disorder hyper-arousal symptoms, scores range from 0 to 4. Higher scores represent greater post traumatic stress disorder hyperarousal symptoms.
Time Frame	Six-months follow-up

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Usual Cardiac Care - Men	Cognitive Behaviour Therapy - Women	Usual Cardiac Care - Women	Cognitive Therapy Group - Men
Arm/Group Description	Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.	Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet	Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.	Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
Measure Participants	73	18	16	76
Mean (Standard Deviation) [units on a scale]	0.61 (0.70)	0.64 (0.87)	0.56 (0.61)	0.52 (0.70)

21. Primary Outcome

Title	Impact of Event Scale-Revised Hyperarousal Scale at 12-months Follow-up
Description	Psychometric measure of post traumatic stress disorder hyper-arousal symptoms, scores range from 0 to 4. Higher scores represent greater post traumatic stress disorder hyperarousal symptoms.
Time Frame	Twelve-months follow-up

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Usual Cardiac Care - Men	Cognitive Behaviour Therapy - Women	Usual Cardiac Care - Women	Cognitive Therapy Group - Men
Arm/Group Description	Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.	Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet	Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.	Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
Measure Participants	73	18	16	76
Mean (Standard Deviation) [units on a scale]	0.64 (0.73)	0.57 (0.54)	0.67 (0.70)	0.39 (0.43)

22. Primary Outcome

Title	Crown-Crisp Experiential Index - Phobic Anxiety Scale at Baseline
Description	Psychometric measure of phobic anxiety, scores range from 1 to 3. Higher scores represent greater phobic anxiety symptoms.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Usual Cardiac Care - Men	Cognitive Behaviour Therapy - Women	Usual Cardiac Care - Women	Cognitive Therapy Group - Men
Arm/Group Description	Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.	Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet	Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.	Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
Measure Participants	73	18	12	76
Mean (Standard Deviation) [units on a scale]	0.98 (0.39)	1.17 (0.28)	1.23 (0.41)	0.83 (0.33)

23. Primary Outcome

Title	Crown-Crisp Experiential Index - Phobic Anxiety Scale at 6-months Follow-up
Description	Psychometric measure of phobic anxiety, scores range from 1 to 3. Higher scores represent greater phobic anxiety symptoms.
Time Frame	Six-months follow-up

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Usual Cardiac Care - Men	Cognitive Behaviour Therapy - Women	Usual Cardiac Care - Women	Cognitive Therapy Group - Men
Arm/Group Description	Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.	Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet	Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.	Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
Measure Participants	73	18	12	76
Mean (Standard Deviation) [units on a scale]	0.92 (0.40)	1.04 (0.38)	1.07 (0.36)	0.84 (0.35)

24. Primary Outcome

Title	Crown-Crisp Experiential Index - Phobic Anxiety Scale at 12-months Follow-up
Description	Psychometric measure of phobic anxiety, scores range from 1 to 3. Higher scores represent greater phobic anxiety symptoms.
Time Frame	Twelve-months follow-up

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Usual Cardiac Care - Men	Cognitive Behaviour Therapy - Women	Usual Cardiac Care - Women	Cognitive Therapy Group - Men
Arm/Group Description	Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.	Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet	Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.	Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
Measure Participants	73	18	12	76
Mean (Standard Deviation) [units on a scale]	0.98 (0.40)	1.13 (0.35)	1.07 (0.40)	0.93 (0.35)

25. Secondary Outcome

Title	SF-36 Physical Component Summary Score at Baseline
Description	Quality of life measure of physical health, scores range from 0 to 100 with higher scores representing better physical health.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Usual Cardiac Care - Men	Cognitive Behaviour Therapy - Women	Usual Cardiac Care - Women	Cognitive Therapy Group - Men
Arm/Group Description	Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.	Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet	Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.	Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
Measure Participants	73	18	16	76
Mean (Standard Deviation) [units on a scale]	39.19 (10.46)	36.13 (7.06)	37.60 (11.81)	38.85 (10.15)

26. Secondary Outcome

Title	SF-36 Physical Component Summary Score at 6-months Follow-up
Description	Quality of life measure of physical health, scores range from 0 to 100 with higher scores representing better physical health.
Time Frame	Six-months follow-up

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Usual Cardiac Care - Men	Cognitive Behaviour Therapy - Women	Usual Cardiac Care - Women	Cognitive Therapy Group - Men
Arm/Group Description	Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.	Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet	Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.	Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
Measure Participants	73	18	16	76
Mean (Standard Deviation) [units on a scale]	42.54 (10.58)	41.46 (12.43)	41.22 (12.85)	42.69 (10.06)

27. Secondary Outcome

Title	SF-36 Physical Component Summary Score at 12-months Follow-up
Description	Quality of life measure of physical health, scores range from 0 to 100 with higher scores representing better physical health.
Time Frame	Twelve-months follow-up

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Usual Cardiac Care - Men	Cognitive Behaviour Therapy - Women	Usual Cardiac Care - Women	Cognitive Therapy Group - Men
Arm/Group Description	Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.	Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet	Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.	Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
Measure Participants	73	18	16	76
Mean (Standard Deviation) [units on a scale]	42.65 (10.33)	42.70 (10.44)	42.82 (14.53)	41.54 (11.23)

28. Secondary Outcome

Title	Percentage of Participants Who Received ICD Therapies
Description	Percentage of participants who received ICD shocks or anti-tachycardia therapies, data extracted from participants ICD devices over follow-up.
Time Frame	12-months follow-up

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Usual Cardiac Care	Cognitive Behaviour Therapy
Arm/Group Description	Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed. This includes all men and women who received UCC.	Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet. These data are on men and women combined within CBT.
Measure Participants	97	96
Number [Percentage of participants]	30.5 39.6%	31.9 167.9%

Adverse Events

Adverse Event Reporting Description	Death was the only adverse event collected.
Arm/Group Title	Usual Cardiac Care - Men		Cognitive Behaviour Therapy - Women		Usual Cardiac Care - Women		Cognitive Therapy Group - Men
Arm/Group Description	Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.		Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet		Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.		Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
All Cause Mortality
	Usual Cardiac Care - Men		Cognitive Behaviour Therapy - Women		Usual Cardiac Care - Women		Cognitive Therapy Group - Men
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Usual Cardiac Care - Men		Cognitive Behaviour Therapy - Women		Usual Cardiac Care - Women		Cognitive Therapy Group - Men
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	4/77 (5.2%)		1/19 (5.3%)		2/20 (10%)		1/77 (1.3%)
General disorders
Deaths	4/77 (5.2%)		1/19 (5.3%)		2/20 (10%)		1/77 (1.3%)
Other (Not Including Serious) Adverse Events
	Usual Cardiac Care - Men		Cognitive Behaviour Therapy - Women		Usual Cardiac Care - Women		Cognitive Therapy Group - Men
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.