Treatment of Depression in Patients With PTSD

Sponsor
US Department of Veterans Affairs (U.S. Fed)
Overall Status
Completed
CT.gov ID
NCT00013091
Collaborator
(none)
120
1
1
59
2

Study Details

Study Description

Brief Summary

Post-traumatic stress disorder is a mental health problem of enormous proportion within the VA system for both male and female veterans. The 40 percent of veterans with PTSD and concurrent clinically significant depression are particularly difficult to treat. Effective and efficient treatment of veterans with this combination of disorders would be of benefit to a significant number of veterans.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Self-management therapy; Psychoeducational group therapy
N/A

Detailed Description

Background:

Post-traumatic stress disorder is a mental health problem of enormous proportion within the VA system for both male and female veterans. The 40 percent of veterans with PTSD and concurrent clinically significant depression are particularly difficult to treat. Effective and efficient treatment of veterans with this combination of disorders would be of benefit to a significant number of veterans.

Objectives:

Well-validated treatments of PTSD and its complications are rare. There are no studies of treatment addressing the sequelae of chronic PTSD, including depressive symptomatology. Our study is the first randomized, controlled study of group psychosocial interventions for the combination of PTSD and depression in male and female veterans. The purpose of the study is to evaluate the impact of two psychosocial interventions on clinical outcomes and on the use of hospital resources by veterans with these co-existing disorders.

Methods:

Male and female veterans with both PTSD and depressive diagnoses will be recruited for the study. Male veterans must have combat-related PTSD, and female veterans will have trauma related to sexual assault. Veterans will be randomly assigned to either Self-Management Therapy (Rehm, 1984), a cognitive-behavioral treatment program for depression, or to a Psychoeducational Group Therapy (Dunn, et al., 1998). Both programs involve short-term group therapies that teach veterans about their disorders, and provide them with new strategies and skills for overcoming them. These therapy groups will be in addition to other standard care that veterans receive within the Trauma Recovery Program at the Houston VA Medical Center. Approximately 120 male veterans and 60 female veterans will be enrolled in the program. Participants will be assessed at pretest, posttest, and at 3-, 6-, and 12-month follow-up periods, utilizing various clinician-administered and self-report instruments of psychiatric symptomatology, psychosocial functioning, constructs targeted by the therapy groups, treatment compliances, and satisfaction.

Status:

Final report preparation.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
120 participants
Masking:
Single
Primary Purpose:
Treatment
Official Title:
Treatment of Depression in Patients With PTSD
Study Start Date :
Oct 1, 1997
Actual Primary Completion Date :
Sep 1, 2002
Actual Study Completion Date :
Sep 1, 2002

Arms and Interventions

Arm Intervention/Treatment
Other: Arm 1

Behavioral: Self-management therapy; Psychoeducational group therapy

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    To be accepted in the study, patients must (a) meet criteria for combat-related (men's cohort) PTSD and either major depressive disorder of dysthymic disorder, (b) not meet criteria for current or past psychosis, score 24 or greater on a Mini-Mental State Examination cognitive screen, (d) not exhibit active suicidality or severity that would preclude participation in the groups, and (e) agree to random assignment and sign informed consent forms. For the women's groups, patients have PTSD related to sexual trauma.

    Exclusion Criteria:

    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

    • US Department of Veterans Affairs

    Investigators

    • Principal Investigator: Nancy Jo Dunn, PhD, Michael E. DeBakey VA Medical Center, Houston, TX

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    US Department of Veterans Affairs
    ClinicalTrials.gov Identifier:
    NCT00013091
    Other Study ID Numbers:
    • IIR 95-074
    First Posted:
    Mar 16, 2001
    Last Update Posted:
    Apr 7, 2015
    Last Verified:
    May 1, 2009
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 7, 2015