A Trial of Group Psychotherapy for Veterans and Military Personnel With Post Traumatic Stress Disorder (PTSD)

• Sponsor: University of Arizona (Other)
• Overall Status: Completed
• CT.gov ID: NCT00984698
• Collaborator: United States Department of Defense (U.S. Fed), Southern Arizona VA Health Care System (U.S. Fed)
• Enrollment: 115
• Locations: 2
• Arms: 2
• Duration (Months): 39
• Patients Per Site: 57.5
• Patients Per Site Per Month: 1.5

Study Details

Study Description

Brief Summary

The purpose of this study is to test the effectiveness of group psychotherapy designed specifically for male veterans and active-duty personnel with Post-traumatic Stress Disorder (PTSD), Major Depressive Disorder (MDD) and with disturbances in their sleep or daily routine.

Condition or Disease	Intervention/Treatment	Phase
Posttraumatic Stress Disorder; Depression; Insomnia Disorder	Behavioral: Cognitive Behavioral Social Rhythm Group Therapy; Behavioral: Present Centered Group Therapy	N/A

Detailed Description

The purpose of this study is to test the effectiveness of a group psychotherapy designed specifically for male veterans and active-duty personnel with Post-traumatic Stress Disorder (PTSD), Major Depressive Disorder (MDD) and with disturbances in their sleep or daily routine. We will compare two group therapies, one of which has been examined in previous studies for veterans with PTSD. Both group therapies have been shown to reduce symptoms of anxiety and depression in some veterans. However, neither group therapy has been proven to be more effective than treatment as usual for PTSD.

Study Design

• Study Type: Interventional
• Actual Enrollment: 115 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Trial of Group Psychotherapy for Veterans and Military Personnel With Post Traumatic Stress Disorder (PTSD)
• Study Start Date: May 1, 2009
• Actual Primary Completion Date: May 1, 2012
• Actual Study Completion Date: Aug 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Structured Therapy Cognitive Behavioral Social Rhythm Group Therapy is designed to improve mood and sleep by stabilizing social rhythms, increasing exposure to ambient light, changing dysfunctional bed/bedtime associations, activating the imagery system by changing nightmare content, and challenging dysfunctional automatic thoughts that might contribute to behavioral inactivation and nonadherence to the therapy protocol. There is no discussion of past traumatic events.	Behavioral: Cognitive Behavioral Social Rhythm Group Therapy; 12 weeks, 2h structured group therapy
Active Comparator: Unstructured Therapy Present Centered Group Therapy includes education about the typical symptoms and features associated with PTSD and MDD, with a focus on how these symptoms affect interpersonal relationships. It uses the group format to decrease isolation, normalize symptoms, and provide the experience of giving and receiving support. Some relaxation training is provided early in therapy. There is no discussion of past traumatic events.	Behavioral: Present Centered Group Therapy; 12 weeks, 2h relatively unstructured group therapy

Outcome Measures

Primary Outcome Measures

1. Depression [post-treatment, at 12 weeks]

   Hamilton Rating Scale for Depression, 17 item The Hamilton Rating Scale for Depression is an interview assessment of depression symptom severity. Total score range is from 0 (no symptoms of depression) to 52 (maximum symptoms of depression).

Secondary Outcome Measures

1. PTSD [post-treatment, at 12 weeks]

   Clinician-Administered PTSD Scale (CAPS), DSM-IV The CAPS is a 17-item interview assessment post-traumatic stress disorder (PTSD) symptom severity. Total score ranges from 0 (no PTSD symptoms) to 136 (maximum PTSD symptoms).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Veteran or active duty military personnel

• Current posttraumatic stress disorder (PTSD), at least moderate severity

• Criterion A exposure to trauma occurring after the age of 18

• Major depressive disorder (MDD), at least moderate severity

• Disturbances in sleep (primary insomnia, insomnia related to PTSD, or nightmare disorder) or daily routine

Exclusion Criteria:

• Current or past bipolar disorder

• Current psychotic disorder

• Substance abuse/dependence in last 30 days

• Uncontrolled serious medical condition or neurological disorder

• Currently working an overnight shift

• Primary untreated sleep apnea, restless legs syndrome

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Southern Arizona VA Healthcare System (SAVAHCS)	Tucson	Arizona	United States	85723
2	University of Arizona	Tucson	Arizona	United States	85724

Sponsors and Collaborators

• University of Arizona
• United States Department of Defense
• Southern Arizona VA Health Care System

Investigators

• Principal Investigator: Patricia Haynes, PhD, University of Arizona

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Tricia Haynes, Assistant Professor, Dept of Psychiatry, University of Arizona
• ClinicalTrials.gov Identifier: NCT00984698
• Other Study ID Numbers: W81XWH-08-2-0121
• First Posted: Sep 25, 2009
• Last Update Posted: Mar 31, 2014
• Last Verified: Feb 1, 2014

• Keywords provided by Tricia Haynes, Assistant Professor, Dept of Psychiatry, University of Arizona: Posttraumatic Stress Disorder; Depression; Sleep Initiation and Maintenance Disorders; Insomnia; Psychotherapy, Group; Cognitive Behavioral Therapy; Randomized Controlled Trial; Veterans; Social Rhythms
• Additional relevant MeSH terms: Sleep Initiation and Maintenance Disorders; Disease; Depression; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic

Study Results

Participant Flow

Recruitment Details	Veterans were recruited from the Southern Arizona VA Health Care System, Mental Health Clinic, September 2009 to July 2011.
Pre-assignment Detail	115 enrolled, 50 eligible, 7 withdrew prior to randomization (3 time commitment, 2 lost contact, 1 changed mind/unknown, 1 travel distance)

Arm/Group Title	Cognitive Behavioral Social Rhythm Group Therapy	Present Centered Group Therapy
Arm/Group Description	CBSRT is designed to improve mood and sleep by stabilizing social rhythms, increasing exposure to ambient light, changing dysfunctional bed/bedtime associations, activating the imagery system by changing nightmare content, and challenging dysfunctional automatic thoughts that might contribute to behavioral inactivation and nonadherence to the therapy protocol. There is no discussion of past traumatic events.	PCGT includes education about the typical symptoms and features associated with PTSD and MDD, with a focus on how these symptoms affect interpersonal relationships. It uses the group format to decrease isolation, normalize symptoms, and provide the experience of giving and receiving support. Some relaxation training is provided early in therapy. There is no discussion of past traumatic events.
Period Title: Overall Study
STARTED	21	22
COMPLETED	18	14
NOT COMPLETED	3	8

Baseline Characteristics

Arm/Group Title	Cognitive Behavioral Social Rhythm Group Therapy	Present Centered Group Therapy	Total
Arm/Group Description	CBSRT is designed to improve mood and sleep by stabilizing social rhythms, increasing exposure to ambient light, changing dysfunctional bed/bedtime associations, activating the imagery system by changing nightmare content, and challenging dysfunctional automatic thoughts that might contribute to behavioral inactivation and nonadherence to the therapy protocol. There is no discussion of past traumatic events.	PCGT includes education about the typical symptoms and features associated with PTSD and MDD, with a focus on how these symptoms affect interpersonal relationships. It uses the group format to decrease isolation, normalize symptoms, and provide the experience of giving and receiving support. Some relaxation training is provided early in therapy. There is no discussion of past traumatic events.	Total of all reporting groups
Overall Participants	21	22	43
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	21 100%	22 100%	43 100%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	45.24 (13.99)	51.46 (12.60)	48.42 (13.51)
Sex: Female, Male (Count of Participants)
Female	0 0%	0 0%	0 0%
Male	21 100%	22 100%	43 100%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	6 28.6%	4 18.2%	10 23.3%
Not Hispanic or Latino	15 71.4%	16 72.7%	31 72.1%
Unknown or Not Reported	0 0%	2 9.1%	2 4.7%

Outcome Measures

1. Secondary Outcome

Title	PTSD
Description	Clinician-Administered PTSD Scale (CAPS), DSM-IV The CAPS is a 17-item interview assessment post-traumatic stress disorder (PTSD) symptom severity. Total score ranges from 0 (no PTSD symptoms) to 136 (maximum PTSD symptoms).
Time Frame	post-treatment, at 12 weeks

Outcome Measure Data

Analysis Population Description

CBSRT arm: 18 participants who completed 75% of psychotherapy sessions; 20 participants who completed 12-week post-treatment assessment PCGT arm: 14 participants who completed 75% of psychotherapy sessions; 17 participants who completed 12-week post-treatment assessment

Arm/Group Title	Cognitive Behavioral Social Rhythm Group Therapy	Present Centered Group Therapy
Arm/Group Description	CBSRT is designed to improve mood and sleep by stabilizing social rhythms, increasing exposure to ambient light, changing dysfunctional bed/bedtime associations, activating the imagery system by changing nightmare content, and challenging dysfunctional automatic thoughts that might contribute to behavioral inactivation and nonadherence to the therapy protocol. There is no discussion of past traumatic events.	PCGT includes education about the typical symptoms and features associated with PTSD and MDD, with a focus on how these symptoms affect interpersonal relationships. It uses the group format to decrease isolation, normalize symptoms, and provide the experience of giving and receiving support. Some relaxation training is provided early in therapy. There is no discussion of past traumatic events.
Measure Participants	20	17
Mean (Standard Deviation) [units on a scale]	67.35 (26.82)	62.47 (24.83)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Cognitive Behavioral Social Rhythm Group Therapy, Present Centered Group Therapy
	Comments	Analysis must be qualified by small sample size, worse baseline symptom severity in CBSRT arm, and greater levels of attrition in PCGT arm
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<.05
	Comments
	Method	Mixed Models Analysis
	Comments

2. Primary Outcome

Title	Depression
Description	Hamilton Rating Scale for Depression, 17 item The Hamilton Rating Scale for Depression is an interview assessment of depression symptom severity. Total score range is from 0 (no symptoms of depression) to 52 (maximum symptoms of depression).
Time Frame	post-treatment, at 12 weeks

Outcome Measure Data

Analysis Population Description

CBSRT arm: 18 participants completed 75% of psychotherapy sessions; 20 participants completed study assessment at 12-week post-treatment time point PCGT arm: 14 participants completed 75% of psychotherapy sessions; 17 participants completed study assessment at 12-week post-treatment time point

Arm/Group Title	Cognitive Behavioral Social Rhythm Group Therapy	Present Centered Group Therapy
Arm/Group Description	CBSRT is designed to improve mood and sleep by stabilizing social rhythms, increasing exposure to ambient light, changing dysfunctional bed/bedtime associations, activating the imagery system by changing nightmare content, and challenging dysfunctional automatic thoughts that might contribute to behavioral inactivation and nonadherence to the therapy protocol. There is no discussion of past traumatic events.	PCGT includes education about the typical symptoms and features associated with PTSD and MDD, with a focus on how these symptoms affect interpersonal relationships. It uses the group format to decrease isolation, normalize symptoms, and provide the experience of giving and receiving support. Some relaxation training is provided early in therapy. There is no discussion of past traumatic events.
Measure Participants	20	17
Mean (Standard Deviation) [units on a scale]	20.30 (6.51)	19.18 (5.79)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Cognitive Behavioral Social Rhythm Group Therapy, Present Centered Group Therapy
	Comments	Analysis must be qualified by small sample size, worse baseline symptom severity in CBSRT arm, and greater levels of attrition in PCGT arm
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<.05
	Comments
	Method	Mixed Models Analysis
	Comments

Adverse Events

Arm/Group Title	Cognitive Behavioral Social Rhythm Group Therapy		Present Centered Group Therapy
Arm/Group Description	CBSRT is designed to improve mood and sleep by stabilizing social rhythms, increasing exposure to ambient light, changing dysfunctional bed/bedtime associations, activating the imagery system by changing nightmare content, and challenging dysfunctional automatic thoughts that might contribute to behavioral inactivation and nonadherence to the therapy protocol. There is no discussion of past traumatic events.		PCGT includes education about the typical symptoms and features associated with PTSD and MDD, with a focus on how these symptoms affect interpersonal relationships. It uses the group format to decrease isolation, normalize symptoms, and provide the experience of giving and receiving support. Some relaxation training is provided early in therapy. There is no discussion of past traumatic events.
All Cause Mortality
	Cognitive Behavioral Social Rhythm Group Therapy		Present Centered Group Therapy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Cognitive Behavioral Social Rhythm Group Therapy		Present Centered Group Therapy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/21 (0%)		0/22 (0%)
Other (Not Including Serious) Adverse Events
	Cognitive Behavioral Social Rhythm Group Therapy		Present Centered Group Therapy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/21 (0%)		0/22 (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.