Mindfulness-Based Cognitive Therapy Intervention to Treat Depression in Individuals With a Traumatic Brain Injury

• Sponsor: Lakehead University (Other)
• Overall Status: Completed
• CT.gov ID: NCT00745940
• Collaborator: Ontario Neurotrauma Foundation (Other)
• Enrollment: 105
• Locations: 3
• Arms: 2
• Duration (Months): 30
• Patients Per Site: 35
• Patients Per Site Per Month: 1.2

Study Details

Study Description

Brief Summary

The purpose of this study is to determine whether mindfulness-based cognitive therapy is effective in reducing depression symptoms in individuals who have experienced a traumatic brain injury.

The investigators hypothesize that participants who are given the ten-week intervention will have fewer depression symptoms than the participants in the control group, and this improvement will be maintained at the three-month follow-up assessment.

Condition or Disease	Intervention/Treatment	Phase
Depression; Traumatic Brain Injury	Behavioral: MBCT for TBI	N/A

Detailed Description

Major depression is a significant chronic problem for people with traumatic brain injury (TBI), and its treatment is difficult. A promising approach to treat depression is mindfulness-based cognitive therapy (MBCT), a relatively new therapeutic approach rooted in mindfulness-based stress-reduction (MBSR) and cognitive behavioural therapy (CBT). This multi-site, randomized, controlled trial of a MBCT intervention will examine the value of this intervention in improving quality of life and decreasing depression in people with TBI. MBCT may represent a time-limited, cost-effective group intervention through which clinicians would have an opportunity to address some of the most debilitating aspects of TBI.

Study Design

• Study Type: Interventional
• Actual Enrollment: 105 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Multi-site, Randomized, Controlled Trial of a Mindfulness-based Cognitive Therapy Intervention for Treating Depression in a Traumatic Brain Injury Population.
• Study Start Date: Nov 1, 2009
• Actual Primary Completion Date: May 1, 2012
• Actual Study Completion Date: May 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: MBCT Intervention Group The curriculum of our mindfulness intervention draws upon elements from the mindfulness-based stress reduction program, and Segal and colleagues manual for mindfulness-based cognitive therapy. It was modified by one of the investigators to address issues associated with traumatic brain injury (e.g., problems with attention, concentration, memory, fatigue). The intervention was increased to ten weeks with one and a half hour weekly sessions, along with a 20-30 minute daily meditation home practice. Further adaptations included simplified language, the use of repetition to reinforce concepts, and visual aids. More attention was paid to fostering learning conditions to encourage an environment of trust and non-judgement. Connections between learning activities was also made more explicit.	Behavioral: MBCT for TBI; Subjects will participate in a 10-week Mindfulness-Based Cognitive Therapy Program led by two trained facilitators. Weekly one-and-a-half hour group sessions will guide subjects through exercises such as meditation, awareness, and breathing techniques aimed at developing skills to help with tension, stress, anxiety and depression. Subjects will be encouraged to practice skills at home and in daily life.; Other Names: MBCT
No Intervention: MBCT Control Group Control group waited.

Outcome Measures

Primary Outcome Measures

1. Beck Depression Inventory - II [Baseline data were collected prior to the intervention and post-intervention data were collected 10 weeks later.]

   The Beck Depression Inventory (BDI-II) is a 21-question multiple-choice self-report inventory, one of the most widely used instruments for measuring the severity of depression. It assesses the intensity of depression into 4 categories ranging from minimal (scores from 0-13) to severe (scores from 29-63) (79). Each item is a list of four statements arranged in increasing severity about a particular symptom of depression. The depression criteria are consistent with those of the Diagnostic and Statistical Manual of Mental Health Disorders-Fourth Edition (DSM-IV). The cognitive-affective factor includes items concerning sadness, past failure, loss of pleasure, guilty feelings, punishment feelings, self-dislike, self-criticalness, suicidal thoughts or wishes, crying, agitation, loss of interest, worthlessness, and irritability. The somatic factor is comprised of loss of energy, changes in sleeping pattern, changes in appetite, concentration difficulty, and tiredness or fatigue.

Secondary Outcome Measures

1. Patient Health Questionnaire (PHQ-9) [Baseline data were collected prior to the intervention and post-intervention data were collected 10 weeks later.]

   The PHQ-9 is a self-administered questionnaire based on the PRIME-MD diagnostic instrument for common mental disorders. Each of the 9 DSM-IV criteria is scored on a four point Likert scale ranging from "0" (not at all) to "3" (nearly every day) with higher scores indicative of greater depression symptoms. Scores range from a low of 0 to a high of 27.

2. Symptom Checklist-90 Revised (Depression Subscale) [Baseline data were collected prior to the intervention and post-intervention data were collected 10 weeks later.]

   The Symptom Checklist-90 Revised (SCL-90-R) is a 90 item self-report questionnaire designed to measure nine primary symptom dimensions: somatization, obsessive-compulsive, interpersonal sensitivity, depression, anxiety, hostility, phobic anxiety, paranoid ideation, and psychoticism from the last two weeks from the current point in time. A five point Likert scale is used ranging from "Not at All" to "Extremely" with higher scores indicative of greater symptoms. There are 13 questions in the depression subscale with scores ranging between 0 and 52. To help with interpretation of all SCL-90-R sub-scales, we transformed this sub-scale total score back to a score between 0 to 4 with higher scores indicating greater depression symptoms.

3. Philadelphia Mindfulness Scale (Awareness Subscale) [Baseline data were collected prior to the intervention and post-intervention data were collected 10 weeks later.]

   The Philadelphia Mindfulness Scale (PHLMS) is a measure of mindfulness to assess present-moment awareness and acceptance. The questionnaire comprises 20 questions rated on a five-point Likert scale with higher scores indicative of greater mindfulness. It comprises two subscales - Awareness and Acceptance. The range of scores on the Awareness subscale is 10 to 50 and the range on the Acceptance subscale is 10 to 50 with higher scores indicative a greater awareness and acceptance respectively.

4. Philadelphia Mindfulness Scale (Acceptance Subscale) [Baseline data were collected prior to the intervention and post-intervention data were collected 10 weeks later.]

   The Philadelphia Mindfulness Scale (PHLMS) is a measure of mindfulness to assess present-moment awareness and acceptance. The questionnaire comprises 20 questions rated on a five-point Likert scale with higher scores indicative of greater mindfulness. It comprises two subscales - Awareness and Acceptance. The range of scores on the Awareness subscale is 10 to 50 and the range on the Acceptance subscale is 10 to 50 with higher scores indicative a greater awareness and acceptance respectively.

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• traumatic brain injury suffered more than one year ago but less than five

• Evidence of depression post-traumatic brain injury (Beck Depression Inventory-II score of 16 or greater)

• Ability to speak and read English

• Age 18 or more

Exclusion Criteria:

• Inability to benefit from the intervention based a consensus process amongst study clinical psychologist and physicians, and from scores on memory and auditory attention (California Verbal Learning Test, Digit Span subsection of Wechsler Adult Intelligence Scale); verbal fluency and executive functioning (Controlled Oral Word Association Test); verbal abstract reasoning (Similarities subsection of Wechsler Adult Intelligence Scale); and executive functioning (Trail Making Test).

• Evidence of unusual psychological processes such as psychosis, suicidal ideation, substance abuse, or major concurrent mental illness (Beck Depression Inventory-II and Symptom Checklist-90-R will supplement the decision-making process of study clinicians).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ottawa Hospital Rehabilitation Centre	Ottawa	Ontario	Canada	K1H 8M2
2	St. Joseph's Care Group	Thunder Bay	Ontario	Canada	P7B 5G7
3	Toronto Rehabilitation Institute	Toronto	Ontario	Canada	M5G 2A2

Sponsors and Collaborators

• Lakehead University
• Ontario Neurotrauma Foundation

Investigators

• Principal Investigator: Michel Bédard, PhD, Lakehead University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Lakehead University
• ClinicalTrials.gov Identifier: NCT00745940
• Other Study ID Numbers: ABI-MIND2-476
• First Posted: Sep 3, 2008
• Last Update Posted: Mar 28, 2014
• Last Verified: Feb 1, 2014

• Keywords provided by Lakehead University: Mindfulness-Based Cognitive Therapy; MBCT; Depression; Traumatic Brain Injury; TBI
• Additional relevant MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Wounds and Injuries; Depression; Depressive Disorder

Study Results

Participant Flow

Recruitment Details	Participants were sought from local sources including: outpatient programs/clinics for individuals with neurological injury, newspaper and television advertisements, a brain injury association, social events related to treatment of brain injury, as well as through appeals to family physicians, psychologists, chiropractors and nurse practitioners.

Arm/Group Title	MBCT Intervention Group	MBCT Control Group
Arm/Group Description	The curriculum of our mindfulness intervention draws upon elements from the mindfulness-based stress reduction program, and Segal and colleagues manual for mindfulness-based cognitive therapy. It was modified by one of the investigators to address issues associated with traumatic brain injury (e.g., problems with attention, concentration, memory, fatigue). The intervention was increased to ten weeks with one and a half hour weekly sessions, along with a 20-30 minute daily meditation home practice. Further adaptations included simplified language, the use of repetition to reinforce concepts, and visual aids. More attention was paid to fostering learning conditions to encourage an environment of trust and non-judgement. Connections between learning activities was also made more explicit.	Control group waited.
Period Title: Overall Study
STARTED	57	48
COMPLETED	38	38
NOT COMPLETED	19	10

Baseline Characteristics

Arm/Group Title	MBCT Intervention Group	MBCT Control Group	Total
Arm/Group Description	The curriculum of our mindfulness intervention draws upon elements from the mindfulness-based stress reduction program, and Segal and colleagues manual for mindfulness-based cognitive therapy. It was modified by one of the investigators to address issues associated with traumatic brain injury (e.g., problems with attention, concentration, memory, fatigue). The intervention was increased to ten weeks with one and a half hour weekly sessions, along with a 20-30 minute daily meditation home practice. Further adaptations included simplified language, the use of repetition to reinforce concepts, and visual aids. More attention was paid to fostering learning conditions to encourage an environment of trust and non-judgement. Connections between learning activities was also made more explicit.	Control group waited.	Total of all reporting groups
Overall Participants	38	38	76
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	38 100%	38 100%	76 100%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	47.10 (12.03)	45.81 (14.80)	46.46 (13.06)
Sex: Female, Male (Count of Participants)
Female	19 50%	15 39.5%	34 44.7%
Male	19 50%	23 60.5%	42 55.3%
Region of Enrollment (participants) [Number]
Canada	38 100%	38 100%	76 100%

Outcome Measures

1. Secondary Outcome

Title	Patient Health Questionnaire (PHQ-9)
Description	The PHQ-9 is a self-administered questionnaire based on the PRIME-MD diagnostic instrument for common mental disorders. Each of the 9 DSM-IV criteria is scored on a four point Likert scale ranging from "0" (not at all) to "3" (nearly every day) with higher scores indicative of greater depression symptoms. Scores range from a low of 0 to a high of 27.
Time Frame	Baseline data were collected prior to the intervention and post-intervention data were collected 10 weeks later.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	MBCT Intervention Group	MBCT Control Group
Arm/Group Description	The curriculum of our mindfulness intervention draws upon elements from the mindfulness-based stress reduction program, and Segal and colleagues manual for mindfulness-based cognitive therapy. It was modified by one of the investigators to address issues associated with traumatic brain injury (e.g., problems with attention, concentration, memory, fatigue). The intervention was increased to ten weeks with one and a half hour weekly sessions, along with a 20-30 minute daily meditation home practice. Further adaptations included simplified language, the use of repetition to reinforce concepts, and visual aids. More attention was paid to fostering learning conditions to encourage an environment of trust and non-judgement. Connections between learning activities was also made more explicit.	Control group waited.
Measure Participants	38	38
Baseline Score on PHQ-9 (total score)	11.53 (5.03)	14.08 (6.52)
Post Intervention Score on PHQ-9 (total score)	10.19 (5.88)	12.84 (6.74)

2. Primary Outcome

Title	Beck Depression Inventory - II
Description	The Beck Depression Inventory (BDI-II) is a 21-question multiple-choice self-report inventory, one of the most widely used instruments for measuring the severity of depression. It assesses the intensity of depression into 4 categories ranging from minimal (scores from 0-13) to severe (scores from 29-63) (79). Each item is a list of four statements arranged in increasing severity about a particular symptom of depression. The depression criteria are consistent with those of the Diagnostic and Statistical Manual of Mental Health Disorders-Fourth Edition (DSM-IV). The cognitive-affective factor includes items concerning sadness, past failure, loss of pleasure, guilty feelings, punishment feelings, self-dislike, self-criticalness, suicidal thoughts or wishes, crying, agitation, loss of interest, worthlessness, and irritability. The somatic factor is comprised of loss of energy, changes in sleeping pattern, changes in appetite, concentration difficulty, and tiredness or fatigue.
Time Frame	Baseline data were collected prior to the intervention and post-intervention data were collected 10 weeks later.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	MBCT Intervention Group	MBCT Control Group
Arm/Group Description	The curriculum of our mindfulness intervention draws upon elements from the mindfulness-based stress reduction program, and Segal and colleagues manual for mindfulness-based cognitive therapy. It was modified by one of the investigators to address issues associated with traumatic brain injury (e.g., problems with attention, concentration, memory, fatigue). The intervention was increased to ten weeks with one and a half hour weekly sessions, along with a 20-30 minute daily meditation home practice. Further adaptations included simplified language, the use of repetition to reinforce concepts, and visual aids. More attention was paid to fostering learning conditions to encourage an environment of trust and non-judgement. Connections between learning activities was also made more explicit.	Control group waited.
Measure Participants	38	38
Baseline Score on BDI-II (total score)	25.47 (8.12)	27.13 (10.61)
Post Intervention Score on the BDI-II (total score	18.84 (10.26)	25.00 (13.12)

3. Secondary Outcome

Title	Symptom Checklist-90 Revised (Depression Subscale)
Description	The Symptom Checklist-90 Revised (SCL-90-R) is a 90 item self-report questionnaire designed to measure nine primary symptom dimensions: somatization, obsessive-compulsive, interpersonal sensitivity, depression, anxiety, hostility, phobic anxiety, paranoid ideation, and psychoticism from the last two weeks from the current point in time. A five point Likert scale is used ranging from "Not at All" to "Extremely" with higher scores indicative of greater symptoms. There are 13 questions in the depression subscale with scores ranging between 0 and 52. To help with interpretation of all SCL-90-R sub-scales, we transformed this sub-scale total score back to a score between 0 to 4 with higher scores indicating greater depression symptoms.
Time Frame	Baseline data were collected prior to the intervention and post-intervention data were collected 10 weeks later.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	MBCT Intervention Group	MBCT Control Group
Arm/Group Description	The curriculum of our mindfulness intervention draws upon elements from the mindfulness-based stress reduction program, and Segal and colleagues manual for mindfulness-based cognitive therapy. It was modified by one of the investigators to address issues associated with traumatic brain injury (e.g., problems with attention, concentration, memory, fatigue). The intervention was increased to ten weeks with one and a half hour weekly sessions, along with a 20-30 minute daily meditation home practice. Further adaptations included simplified language, the use of repetition to reinforce concepts, and visual aids. More attention was paid to fostering learning conditions to encourage an environment of trust and non-judgement. Connections between learning activities was also made more explicit.	Control group waited.
Measure Participants	38	38
Baseline Symptom Checklist-90-R (Depression)	1.62 (0.80)	1.36 (0.90)
Post Intervention Symptom Checkl-90-R (Depression)	1.74 (0.94)	1.49 (1.04)

4. Secondary Outcome

Title	Philadelphia Mindfulness Scale (Awareness Subscale)
Description	The Philadelphia Mindfulness Scale (PHLMS) is a measure of mindfulness to assess present-moment awareness and acceptance. The questionnaire comprises 20 questions rated on a five-point Likert scale with higher scores indicative of greater mindfulness. It comprises two subscales - Awareness and Acceptance. The range of scores on the Awareness subscale is 10 to 50 and the range on the Acceptance subscale is 10 to 50 with higher scores indicative a greater awareness and acceptance respectively.
Time Frame	Baseline data were collected prior to the intervention and post-intervention data were collected 10 weeks later.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	MBCT Intervention Group	MBCT Control Group
Arm/Group Description	The curriculum of our mindfulness intervention draws upon elements from the mindfulness-based stress reduction program, and Segal and colleagues manual for mindfulness-based cognitive therapy. It was modified by one of the investigators to address issues associated with traumatic brain injury (e.g., problems with attention, concentration, memory, fatigue). The intervention was increased to ten weeks with one and a half hour weekly sessions, along with a 20-30 minute daily meditation home practice. Further adaptations included simplified language, the use of repetition to reinforce concepts, and visual aids. More attention was paid to fostering learning conditions to encourage an environment of trust and non-judgement. Connections between learning activities was also made more explicit.	Control group waited.
Measure Participants	38	38
Baseline Score on PHLMS (Awareness Subscale)	33.84 (6.62)	33.97 (6.02)
Post Intervention Score on PHLMS (Awareness)	35.10 (6.01)	34.42 (5.17)

5. Secondary Outcome

Title	Philadelphia Mindfulness Scale (Acceptance Subscale)
Description	The Philadelphia Mindfulness Scale (PHLMS) is a measure of mindfulness to assess present-moment awareness and acceptance. The questionnaire comprises 20 questions rated on a five-point Likert scale with higher scores indicative of greater mindfulness. It comprises two subscales - Awareness and Acceptance. The range of scores on the Awareness subscale is 10 to 50 and the range on the Acceptance subscale is 10 to 50 with higher scores indicative a greater awareness and acceptance respectively.
Time Frame	Baseline data were collected prior to the intervention and post-intervention data were collected 10 weeks later.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	MBCT Intervention Group	MBCT Control Group
Arm/Group Description	The curriculum of our mindfulness intervention draws upon elements from the mindfulness-based stress reduction program, and Segal and colleagues manual for mindfulness-based cognitive therapy. It was modified by one of the investigators to address issues associated with traumatic brain injury (e.g., problems with attention, concentration, memory, fatigue). The intervention was increased to ten weeks with one and a half hour weekly sessions, along with a 20-30 minute daily meditation home practice. Further adaptations included simplified language, the use of repetition to reinforce concepts, and visual aids. More attention was paid to fostering learning conditions to encourage an environment of trust and non-judgement. Connections between learning activities was also made more explicit.	Control group waited.
Measure Participants	38	38
Baseline Score on PHLMS (Acceptance Subscale)	28.35 (7.42)	28.14 (7.45)
Post Intervention Score on PHLMS (Acceptance)	31.16 (7.35)	29.39 (7.55)

Adverse Events

Arm/Group Title	MBCT Intervention Group		MBCT Control Group
Arm/Group Description	The curriculum of our mindfulness intervention draws upon elements from the mindfulness-based stress reduction program, and Segal and colleagues manual for mindfulness-based cognitive therapy. It was modified by one of the investigators to address issues associated with traumatic brain injury (e.g., problems with attention, concentration, memory, fatigue). The intervention was increased to ten weeks with one and a half hour weekly sessions, along with a 20-30 minute daily meditation home practice. Further adaptations included simplified language, the use of repetition to reinforce concepts, and visual aids. More attention was paid to fostering learning conditions to encourage an environment of trust and non-judgement. Connections between learning activities was also made more explicit.		Control group waited.
All Cause Mortality
	MBCT Intervention Group		MBCT Control Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	MBCT Intervention Group		MBCT Control Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/57 (0%)		0/48 (0%)
Other (Not Including Serious) Adverse Events
	MBCT Intervention Group		MBCT Control Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/57 (0%)		0/48 (0%)

Limitations/Caveats

It is not possible to generalize our findings to the general population of people with a traumatic brain injury. Participants self-selected. Some did not complete the intervention. The control group was a "wait-list" control group.

More Information

Certain Agreements

Principal Investigators are NOT 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.