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

NCT ID: NCT00984698

Last Updated: 2014-03-31

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

115 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-05-31

Study Completion Date

2012-08-31

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.

Conditions

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Posttraumatic Stress Disorder Depression Insomnia Disorder

Keywords

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Posttraumatic Stress Disorder Depression Sleep Initiation and Maintenance Disorders Insomnia Psychotherapy, Group Cognitive Behavioral Therapy Randomized Controlled Trial Veterans Social Rhythms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Cognitive Behavioral Social Rhythm Group Therapy

Intervention Type BEHAVIORAL

12 weeks, 2h structured group therapy

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.

Group Type ACTIVE_COMPARATOR

Present Centered Group Therapy

Intervention Type BEHAVIORAL

12 weeks, 2h relatively unstructured group therapy

Interventions

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Cognitive Behavioral Social Rhythm Group Therapy

12 weeks, 2h structured group therapy

Intervention Type BEHAVIORAL

Present Centered Group Therapy

12 weeks, 2h relatively unstructured group therapy

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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United States Department of Defense

FED

Sponsor Role collaborator

Southern Arizona VA Health Care System

FED

Sponsor Role collaborator

University of Arizona

OTHER

Sponsor Role lead

Responsible Party

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Tricia Haynes

Assistant Professor, Dept of Psychiatry

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Patricia Haynes, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Arizona

Locations

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Southern Arizona VA Healthcare System (SAVAHCS)

Tucson, Arizona, United States

Site Status

University of Arizona

Tucson, Arizona, United States

Site Status

Countries

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United States

References

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Haynes PL, Burger SB, Kelly M, Emert S, Perkins S, Shea MT. Cognitive behavioral social rhythm group therapy versus present centered group therapy for veterans with posttraumatic stress disorder and major depressive disorder: A randomized controlled pilot trial. J Affect Disord. 2020 Dec 1;277:800-809. doi: 10.1016/j.jad.2020.09.009. Epub 2020 Sep 7.

Reference Type DERIVED
PMID: 33065820 (View on PubMed)

Other Identifiers

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W81XWH-08-2-0121

Identifier Type: -

Identifier Source: org_study_id