Exposure Therapy For Veterans With PTSD And Panic Attacks

• Sponsor: VA Office of Research and Development (U.S. Fed)
• Overall Status: Completed
• CT.gov ID: NCT01033136
• Collaborator: (none)
• Enrollment: 93
• Location: 1
• Arms: 2
• Actual Duration (Months): 48
• Patients Per Site Per Month: 1.9

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 PTSD and panic disorder (PD). This study will examine the effectiveness of MCET-V by comparing it to Cognitive Processing Therapy, a standard PTSD treatment.

Condition or Disease	Intervention/Treatment	Phase
PTSD; Panic Attacks	Behavioral: Multiple Channel Exposure Therapy - Veterans; Behavioral: Cognitive Processing Therapy	N/A

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 study is to evaluate the effectiveness of the multi-component cognitive-behavioral treatment in comparison to standard PTSD treatment in military personnel returning from active duty.

Study Design

• Study Type: Interventional
• Actual Enrollment: 93 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Intervention Model Description: Multiple Channel Exposure Therapy is a behavioral treatment that simultaneously targets panic disorder and PTSD.Multiple Channel Exposure Therapy is a behavioral treatment that simultaneously targets panic disorder and PTSD.
• Masking: Single (Outcomes Assessor)
• Masking Description: Post-treatment and follow-up assessments are conducted by an assessor masked to treatment condition.
• Primary Purpose: Treatment
• Official Title: Exposure Therapy for Veterans With PTSD and Panic Attacks
• Actual Study Start Date: Jan 1, 2013
• Actual Primary Completion Date: Sep 30, 2016
• Actual Study Completion Date: Jan 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: MCET-V Multiple Channel Exposure Therapy -Veterans (MCET-V) is a 12-session cognitive-behavioral treatment for persons with comorbid PTSD and panic attacks. It is an integrated treatment designed to target panic and PTSD symptoms simultaneously.	Behavioral: Multiple Channel Exposure Therapy - Veterans; MCET-V offers individual therapy that provides psychoeducation about panic attacks and trauma and involves behavioral and cognitive exposure exercises.; Other Names: MCET-V
Active Comparator: CPT Cognitive Processing Therapy (CPT) is a 12-session cognitive-behavioral treatment for persons with PTSD. It is a gold-standard cognitive behavioral intervention designed to target PTSD symptoms.	Behavioral: Cognitive Processing Therapy; CPT offers individual therapy that targets trauma and PTSD symptoms via cognitive restructuring.; Other Names: CPT

Outcome Measures

Primary Outcome Measures

1. Change in PTSD Symptoms (CAPS) Between MCET-V and CPT Groups [Baseline, 1-week post-treatment and 3-month follow-up]

   The CAPS is a clinician-administered assessment of the presence and severity of PTSD symptoms. Scores range from 0 - 136, with higher scores indicating greater symptom severity.

2. Change in PDSS Scores Over Time for MCET-V and CPT Groups [Baseline, 1-week post, and 3-month follow-up]

   The Panic Disorder Severity Scale (PDSS) is a clinician-rated assessment of the presence and severity of panic symptoms. Scores range from 0 - 28, with higher scores indicating greater symptom severity.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• being a Veteran of any era;

• being enrolled in the TRP at the 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 ADIS-IV & BDI-II);

• cognitive impairment as indicated by the 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: NCT01033136
• Other Study ID Numbers: CDA2-012-09F
• First Posted: Dec 16, 2009
• Last Update Posted: Sep 17, 2018
• Last Verified: Aug 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Panic Disorder

Study Results

Participant Flow

Recruitment Details	A total of 93 participants were recruited for the study. Of these participants, 68 met study inclusion criteria and were included in data analyses.

Arm/Group Title	Multiple Channel Exposure Therapy (MCET-V)	Cognitive Processing Therapy (CPT)
Arm/Group Description	MCET-V is a 12-session cognitive-behavioral treatment for persons with comorbid PTSD and panic attacks. It is an integrated treatment designed to target panic and PTSD symptoms simultaneously.	CPT is a 12-session cognitive-behavioral treatment for persons with PTSD. It is a gold-standard cognitive behavioral intervention designed to target PTSD symptoms.
Period Title: Baseline Assessment
STARTED	36	32
COMPLETED	30	26
NOT COMPLETED	6	6
Period Title: Baseline Assessment
STARTED	30	26
COMPLETED	16	15
NOT COMPLETED	14	11
Period Title: Baseline Assessment
STARTED	16	15
COMPLETED	14	13
NOT COMPLETED	2	2

Baseline Characteristics

Arm/Group Title	Multiple Channel Exposure Therapy (MCET-V)	Cognitive Processing Therapy (CPT)	Total
Arm/Group Description	MCET-V is a 12-session cognitive-behavioral treatment for persons with comorbid PTSD and panic attacks. It is an integrated treatment designed to target panic and PTSD symptoms simultaneously.	CPT is a 12-session cognitive-behavioral treatment for persons with PTSD. It is a gold-standard cognitive behavioral intervention designed to target PTSD symptoms.	Total of all reporting groups
Overall Participants	36	32	68
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	33 91.7%	29 90.6%	62 91.2%
>=65 years	3 8.3%	3 9.4%	6 8.8%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	42.61 (13.70)	41.56 (13.26)	42.12 (13.40)
Sex: Female, Male (Count of Participants)
Female	7 19.4%	7 21.9%	14 20.6%
Male	29 80.6%	25 78.1%	54 79.4%
Race/Ethnicity, Customized (Count of Participants)
White	17 47.2%	12 37.5%	29 42.6%
African American	10 27.8%	13 40.6%	23 33.8%
Latino	7 19.4%	6 18.8%	13 19.1%
Asian	0 0%	0 0%	0 0%
Other	2 5.6%	1 3.1%	3 4.4%

Outcome Measures

1. Primary Outcome

Title	Change in PTSD Symptoms (CAPS) Between MCET-V and CPT Groups
Description	The CAPS is a clinician-administered assessment of the presence and severity of PTSD symptoms. Scores range from 0 - 136, with higher scores indicating greater symptom severity.
Time Frame	Baseline, 1-week post-treatment and 3-month follow-up

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Multiple Channel Exposure Therapy (MCET-V)	Cognitive Processing Therapy (CPT)
Arm/Group Description	MCET-V is a 12-session cognitive-behavioral treatment for persons with comorbid PTSD and panic attacks. It is an integrated treatment designed to target panic and PTSD symptoms simultaneously.	CPT is a 12-session cognitive-behavioral treatment for persons with PTSD. It is a gold-standard cognitive behavioral intervention designed to target PTSD symptoms.
Measure Participants	36	32
Pre-Treatment	81.8 (21)	80.5 (19.9)
Post-Treatment (1 week)	67.8 (24.2)	68.1 (26.4)
Follow-Up (3 months)	66.6 (20.4)	66.2 (28.0)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Multiple Channel Exposure Therapy (MCET-V), Cognitive Processing Therapy (CPT)
	Comments
	Type of Statistical Test	Equivalence
	Comments	To test if MCET is equivalent to CPT in decreasing PTSD symptoms, we test the equivalence of the proportion of patients whose CAPS scores decrease by 10 from baseline, by testing whether the difference in proportions between the 2 interventions ≤ to the equivalence margin δb of .20. Results are reported based on 3-month follow-up data.
Statistical Test of Hypothesis	p-Value	0.30
	Comments	The threshold for statistical significance is p <.05 and is not adjusted for multiple comparisons.
	Method	Fisher Exact
	Comments

2. Primary Outcome

Title	Change in PDSS Scores Over Time for MCET-V and CPT Groups
Description	The Panic Disorder Severity Scale (PDSS) is a clinician-rated assessment of the presence and severity of panic symptoms. Scores range from 0 - 28, with higher scores indicating greater symptom severity.
Time Frame	Baseline, 1-week post, and 3-month follow-up

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Multiple Channel Exposure Therapy -Veterans (MCET-V)	Cognitive Processing Therapy (CPT)
Arm/Group Description	Multiple Channel Exposure Therapy -Veterans (MCET-V) is a 12-session cognitive-behavioral treatment for persons with comorbid PTSD and panic attacks. It is an integrated treatment designed to target panic and PTSD symptoms simultaneously.	Cognitive Processing Therapy (CPT) is a 12-session cognitive-behavioral treatment for persons with PTSD. It is a gold-standard cognitive behavioral intervention designed to target PTSD symptoms.
Measure Participants	36	32
Baseline	18.5 (3.84)	16.28 (4.57)
1-week post	12.81 (6.33)	10.20 (5.75)
3-month follow up	10.93 (7.53)	10.62 (6.51)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Multiple Channel Exposure Therapy (MCET-V), Cognitive Processing Therapy (CPT)
	Comments	Longitudinal analysis of PDSS scores
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.68
	Comments	The threshold for statistical significance is p <.05 and is not adjusted for multiple comparisons.
	Method	Mixed Models Analysis
	Comments	Degrees of freedom: 2, 54

Adverse Events

Arm/Group Title	Multiple Channel Exposure Therapy -Veterans (MCET-V)		Cognitive Processing Therapy (CPT)
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.		CPT is a cognitive-behavioral treatment for persons with PTSD Cognitive-Processing Therapy: Participants will be randomly assigned to receive either MCET-V or cognitive processing therapy (CPT), a standard PTSD treatment. Patients in both the MCET-V and CPT conditions will receive 12, 90-minute sessions of individual therapy twice a week over a 6-week period.
All Cause Mortality
	Multiple Channel Exposure Therapy -Veterans (MCET-V)		Cognitive Processing Therapy (CPT)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Multiple Channel Exposure Therapy -Veterans (MCET-V)		Cognitive Processing Therapy (CPT)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/36 (0%)		0/32 (0%)
Other (Not Including Serious) Adverse Events
	Multiple Channel Exposure Therapy -Veterans (MCET-V)		Cognitive Processing Therapy (CPT)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/36 (0%)		0/32 (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.