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

NCT00984698 | Completed Results DMC

• 1 other identifier: W81XWH-08-2-0121
• Study Type: interventional
• Target: 115
• Locations: 1 country
• Sites: 2

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.

Conditions

Posttraumatic Stress Disorder; Depression; Insomnia Disorder

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• PTSD

  post-treatment, at 12 weeks

Study Arms (2)

Structured Therapy

EXPERIMENTAL

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

Unstructured Therapy

ACTIVE COMPARATOR

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

Interventions

Cognitive Behavioral Social Rhythm Group Therapy BEHAVIORAL

12 weeks, 2h structured group therapy

Structured Therapy

Present Centered Group Therapy BEHAVIORAL

12 weeks, 2h relatively unstructured group therapy

Unstructured Therapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (2)

Southern Arizona VA Healthcare System (SAVAHCS)

Tucson, Arizona, 85723, United States

Location

University of Arizona

Tucson, Arizona, 85724, United States

Location

Related Publications (1)

• 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.

  PMID: 33065820 DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Depression; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Behavioral Symptoms; Behavior; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Results Point of Contact

• Title: Dr. Patricia Haynes, Assistant Professor
• Organization: University of Arizona

thaynes@email.arizona.edu

5206261855

Study Officials

• Patricia Haynes, PhD

  University of Arizona

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Dept of Psychiatry

Study Record Dates

• First Submitted: September 24, 2009
• First Posted: September 25, 2009
• Study Start: May 1, 2009
• Primary Completion: May 1, 2012
• Study Completion: August 1, 2012
• Last Updated: March 31, 2014
• Results First Posted: March 31, 2014

Record last verified: 2014-02

Locations

US (2)