Exposure Therapy for Veterans With PTSD and Panic Attacks (Phase 1)

• Sponsor: VA Office of Research and Development (U.S. Fed)
• Overall Status: Completed
• CT.gov ID: NCT01551199
• Collaborator: (none)
• Enrollment: 7
• Location: 1
• Arm: 1
• Duration (Months): 15
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief Summary

To evaluate the feasibility, acceptability and effectiveness of Multiple Channel Exposure Therapy-Veterans (MCET-V) as a treatment for returning service members with comorbid posttraumatic stress disorder (PTSD) and panic disorder (PD) in two phases. The first phase of the study will examine the feasibility and acceptability of MCET-V.

Condition or Disease	Intervention/Treatment	Phase
PTSD; Panic Attacks	Behavioral: Multiple Channel Exposure Therapy- Veterans	Phase 1

Detailed Description

With the increasing number of Operations Iraqi Freedom and Enduring Freedom (OIF/OEF) veterans returning from war-zone areas, many will experience anxiety disorders such as PTSD and comorbid problems. Currently, about one in every six OIF/OEF veterans experiences PTSD and co-occurring PD. Although effective treatments exist for treating one or the other, we do not yet have treatments that can simultaneously target PTSD and PD. Thus, recent attention has focused on the development of multi-component treatments that simultaneously address PTSD and PD. This study is the first systematic investigation of a time-limited, multi-component cognitive-behavioral treatment for veterans with specific comorbid anxiety problems. The purpose of the first phase of the study is to evaluate the feasibility and acceptability of the multi-component cognitive-behavioral treatment in an open trial.

Study Design

• Study Type: Interventional
• Actual Enrollment: 7 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Exposure Therapy for Veterans With PTSD and Panic Attacks (Phase 1)
• Study Start Date: Mar 1, 2012
• Actual Primary Completion Date: Feb 1, 2013
• Actual Study Completion Date: Jun 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Multiple Channel Exposure Therapy MCET-V is a cognitive-behavioral treatment for persons with comorbid PTSD and panic attacks	Behavioral: Multiple Channel Exposure Therapy- Veterans; Individual therapy design completed over a 12-week period. The treatment will include psychoeducation about panic attacks and trauma and behavioral and cognitive exposure exercises.; Other Names: MCET-V

Outcome Measures

Primary Outcome Measures

1. Clinician Administered PTSD Scale (CAPS) [1-week post-treatment (approximately week 14)]

   The CAPS is a clinician-administered interview assessing 17 symptoms of PTSD (based on DSM-IV criteria). Frequency of symptoms are rated on a scale from 0 (never/none) to 4 (daily/almost every day). Intensity of symptoms are rated using a scale of 0 (none) to 4 (extreme). Total severity score is derived by summing the frequency and intensity scores. A recommended cut-off of 45 is used to determine the presence of full PTSD. Higher scores suggest greater symptom severity.

2. Clinician Administered PTSD Scale (CAPS) [3-month follow-up (approximately week 26)]

   The CAPS is a clinician-administered interview assessing 17 symptoms of PTSD (based on DSM-IV criteria). Frequency of symptoms are rated on a scale from 0 (never/none) to 4 (daily/almost every day). Intensity of symptoms are rated using a scale of 0 (none) to 4 (extreme). Total severity score is derived by summing the frequency and intensity scores. A recommended cut-off of 45 is used to determine the presence of full PTSD. Higher scores suggest greater symptom severity.

Secondary Outcome Measures

1. Anxiety Disorders Interview Schedule- DSM-IV (ADIS-IV) [3 Months]

   The ADIS-IV is a semi-structured diagnostic interview for anxiety disorders (based on DSM-IV criteria). DSM-IV criteria for panic disorder include recurrent unexpected panic attacks and (1) persistant concern or worry about additional panic attacks or their consequences or (2) significant change in behavior related to panic attacks.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 64 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• being a veteran of any era;

• being enrolled in the Trauma Recovery Program (TRP) at the Michael E. DeBakey Veterans Affairs Medical Center (MEDVAMC), with a current diagnosis of PTSD and PD;

• being stable on psychotropic medication for 4 weeks before study participation; and

• being at least 18 years of age.

Exclusion Criteria:

• active substance dependence, or bipolar or psychotic disorders;

• severe depression and active suicidal ideation and intent (based on Structured Clinical Interview for DSM-IV disorders [SCID-IV] & Beck Depression Inventory-2nd edition [BDI-II]);

• cognitive impairment as indicated by the St. Louis University Mental Status exam (SLUMS); and

• veterans currently receiving psychosocial treatment specifically targeting PTSD or panic symptoms.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Michael E. DeBakey VA Medical Center, Houston, TX	Houston	Texas	United States	77030

Sponsors and Collaborators

• VA Office of Research and Development

Investigators

• Principal Investigator: Ellen Teng, PhD, Michael E. DeBakey VA Medical Center, Houston, TX

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: VA Office of Research and Development
• ClinicalTrials.gov Identifier: NCT01551199
• Other Study ID Numbers: CDA2-012-09F-1
• First Posted: Mar 12, 2012
• Last Update Posted: Feb 23, 2017
• Last Verified: Jan 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Panic Disorder

Study Results

Participant Flow

Arm/Group Title	Multiple Channel Exosure Therapy (MCET-V)
Arm/Group Description	MCET-V is a cognitive-behavioral treatment for persons with comorbid PTSD and panic attacks Multiple Channel Exposure Therapy- Veterans: Individual therapy design completed twice a week over a 6-week period. The treatment will include psychoeducation about panic attacks and trauma and behavioral and cognitive exposure exercises.
Period Title: Overall Study
STARTED	7
COMPLETED	2
NOT COMPLETED	5

Baseline Characteristics

Arm/Group Title	Multiple Channel Exposure Therapy (MCET)
Arm/Group Description	MCET-V is a cognitive-behavioral treatment for persons with comorbid PTSD and panic attacks Multiple Channel Exposure Therapy- Veterans: Individual therapy design completed twice a week over a 6-week period. The treatment will include psychoeducation about panic attacks and trauma and behavioral and cognitive exposure exercises.
Overall Participants	7
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	37 (6.9)
Gender (Count of Participants)
Female	4 57.1%
Male	3 42.9%
Beck Anxiety Inventory (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	40.6 (9.93)
Beck Depression Inventory (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	36.4 (8.11)

Outcome Measures

1. Primary Outcome

Title	Clinician Administered PTSD Scale (CAPS)
Description	The CAPS is a clinician-administered interview assessing 17 symptoms of PTSD (based on DSM-IV criteria). Frequency of symptoms are rated on a scale from 0 (never/none) to 4 (daily/almost every day). Intensity of symptoms are rated using a scale of 0 (none) to 4 (extreme). Total severity score is derived by summing the frequency and intensity scores. A recommended cut-off of 45 is used to determine the presence of full PTSD. Higher scores suggest greater symptom severity.
Time Frame	1-week post-treatment (approximately week 14)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	MCET-V
Arm/Group Description	MCET-V is a 12-session intervention targeting panic and PTSD symptoms.
Measure Participants	2
Mean (Standard Deviation) [units on a scale]	29.5 (23.3)

2. Secondary Outcome

Title	Anxiety Disorders Interview Schedule- DSM-IV (ADIS-IV)
Description	The ADIS-IV is a semi-structured diagnostic interview for anxiety disorders (based on DSM-IV criteria). DSM-IV criteria for panic disorder include recurrent unexpected panic attacks and (1) persistant concern or worry about additional panic attacks or their consequences or (2) significant change in behavior related to panic attacks.
Time Frame	3 Months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	MCET-V
Arm/Group Description	MCET-V is a 12-session intervention targeting panic and PTSD symptoms.
Measure Participants	2
Participants without panic disorder	100 1428.6%
Participants with panic disorder	0 0%

3. Primary Outcome

Title	Clinician Administered PTSD Scale (CAPS)
Description	The CAPS is a clinician-administered interview assessing 17 symptoms of PTSD (based on DSM-IV criteria). Frequency of symptoms are rated on a scale from 0 (never/none) to 4 (daily/almost every day). Intensity of symptoms are rated using a scale of 0 (none) to 4 (extreme). Total severity score is derived by summing the frequency and intensity scores. A recommended cut-off of 45 is used to determine the presence of full PTSD. Higher scores suggest greater symptom severity.
Time Frame	3-month follow-up (approximately week 26)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	MCET-V
Arm/Group Description	MCET-V is a 12-session intervention targeting panic and PTSD symptoms.
Measure Participants	2
Mean (Standard Deviation) [units on a scale]	17 (1.41)

Adverse Events

Arm/Group Title	Arm 1
Arm/Group Description	MCET-V is a cognitive-behavioral treatment for persons with comorbid PTSD and panic attacks Multiple Channel Exposure Therapy- Veterans: Individual therapy design completed twice a week over a 6-week period. The treatment will include psychoeducation about panic attacks and trauma and behavioral and cognitive exposure exercises.
All Cause Mortality
	Arm 1
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Arm 1
	Affected / at Risk (%)	# Events
Total	0/7 (0%)
Other (Not Including Serious) Adverse Events
	Arm 1
	Affected / at Risk (%)	# Events
Total	0/7 (0%)

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.