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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Posttraumatic Stress Disorder, Depression, Insomnia Disorder

Intervention / Treatment
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* Behavioral: Cognitive Behavioral Social Rhythm Group Therapy
* Behavioral: Present Centered Group Therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Structured Therapy<br>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<br>* 12 weeks, 2h structured group therapy<br>|
| Active Comparator: Unstructured Therapy<br>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<br>* 12 weeks, 2h relatively unstructured group therapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depression | 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). | post-treatment, at 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PTSD | 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). | post-treatment, at 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Depression, Posttraumatic Stress Disorder, Sleep Initiation and Maintenance Disorders, Insomnia, Psychotherapy, Group, Cognitive Behavioral Therapy, Randomized Controlled Trial, Veterans, Social Rhythms