Clinical trial NCT00013091: Treatment of Depression in Patients With PTSD
Official title: Treatment of Depression in Patients With PTSD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: PTSD
Depression
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2001-03-16
Enrollment: 120
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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:

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: Michael E. DeBakey VA Medical Center, Houston, TX
state: Texas
Study officials:
affiliation: Michael E. DeBakey VA Medical Center, Houston, TX
name: Nancy Jo Dunn, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dunn NJ, Yanasak E, Schillaci J, Simotas S, Rehm LP, Souchek J, Menke T, Ashton C, Hamilton JD. Personality disorders in veterans with posttraumatic stress disorder and depression. J Trauma Stress. 2004 Feb;17(1):75-82. doi: 10.1023/B:JOTS.0000014680.54051.50.