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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00893152
Other study ID # DHI 08-097
Secondary ID CAVHS 0156_2008I
Status Completed
Phase N/A
First received May 1, 2009
Last updated March 24, 2015
Start date November 2009
Est. completion date March 2012

Study information

Verified date March 2015
Source VA Office of Research and Development
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Observational

Clinical Trial Summary

Post-traumatic stress disorder (PTSD), prevalent among returning OEF/OIF/OND Veterans, has a powerful impact on family functioning. Good family relationships appear to moderate its impact; stressful relationships may reduce the benefits of treatment. A program that assists both Veteran and family in coping with the Veteran's PTSD could directly improve the Veteran's re-adjustment and well-being and indirectly improve his/her social and occupational functioning.


Description:

Background: Post-traumatic stress disorder (PTSD), a potentially severe and persistent condition that affects social, occupational and family functioning, is prevalent among returning OIF/OEF veterans. PTSD has a powerful impact on family functioning. Because good family relationships appear to moderate its impact, while stressful relationships may reduce the benefits of treatment, a program that enhances family functioning by assisting both veteran and family in coping with the veteran's PTSD could directly improve the veteran's adjustment and well-being, and indirectly improve his/her social and occupational functioning. Effective programs for OIF/OEF veterans are urgently needed. This study will address critical gaps in knowledge about relevant needs and preferences of OIF/OEF veterans and families, and how best to involve families in treatment.

Objectives: The specific aim of this project is to describe the needs and preferences of OIF/OEF service-era veterans with PTSD and their families relevant to family involvement in care.

Methods: This two-site study was conducted at the Central Arkansas Veterans Healthcare System (CAVHS, Little Rock, AR) and Oklahoma City (OKC) VAMCs. Qualitative (focus-group or individual) interviews were conducted with 47 Veterans (33 CAVHS, 14 OKC) and 36 Veteran-designated family members (19 CAVHS/17 OKC). Veterans were eligible if they were 18-65 years of age, had served in Iraq or Afghanistan since October 2001, had received treatment for PTSD at the CAVHS or OKC VAMCs in the previous 12 months, and had an adult family member who might be willing to participate in an interview. Family was defined broadly to include relatives, significant others, and friends the Veteran considered "as close as family." Interviews addressed perceived needs related to the Veteran's readjustment to civilian life, desires for family involvement in treatment, types of services that were/would have been helpful and attractive during readjustment, as well as logistic considerations (e.g., frequency of meetings). Qualitative data were analyzed using the techniques of constant comparison and content analysis. Demographic data, deployment data, and data on preferred program structure and format were collected via an anonymous paper-and-pencil questionnaire administered following the qualitative interview.

Status: Data collection and analysis of main themes are complete. In depth analysis of additional themes is ongoing.


Recruitment information / eligibility

Status Completed
Enrollment 83
Est. completion date March 2012
Est. primary completion date October 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

Veteran:

1. Age 18-65;

2. 2 or more inpatient or outpatient mental health contacts at LR or OKC VAMC in the previous 12 months with a primary diagnosis of PTSD;

3. Served in Iraq or Afghanistan since 10/7/01;

4. Have a family member who may be willing to participate in the focus group.

Family:

1. Age > 18

2. English speaking

3. Be the designated "family member" of a participating veteran

Exclusion Criteria:

- Non-English speaking

Study Design

N/A


Locations

Country Name City State
United States Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR No. Little Rock Arkansas
United States VA Medical Center, Oklahoma City Oklahoma City Oklahoma

Sponsors (1)

Lead Sponsor Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Qualitative Interviews - Perspectives on Family Involvement in PTSD Treatment This is qualitative research. "Outcomes" were themes raised with regard to content to be included in a multi-family group psychoeducation program for OEF/OIF/OND veterans with PTSD and family members. During the 1-1.5 hour interviews No
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