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Family Involvement in Treatment for PTSD

Primary Purpose

Posttraumatic Stress Disorder

Status
Completed
Phase
Locations
United States
Study Type
Observational
Intervention
Sponsored by
US Department of Veterans Affairs
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an observational trial for Posttraumatic Stress Disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR
  • VA Medical Center, Oklahoma City

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Arm Label

Group 1

Group 2

Group 3

Arm Description

Male veterans (focus groups and individual interviews)

Female veterans (focus groups and individual interviews)

Family members of participating veterans (focus groups and individual interviews)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
May 1, 2009
Last Updated
March 24, 2015
Sponsor
US Department of Veterans Affairs
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1. Study Identification

Unique Protocol Identification Number
NCT00893152
Brief Title
Family Involvement in Treatment for PTSD
Official Title
Perspectives on Enhancing Family Involvement in Treatment for PTSD
Study Type
Observational

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
March 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
US Department of Veterans Affairs

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Posttraumatic Stress Disorder

7. Study Design

Enrollment
83 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Description
Male veterans (focus groups and individual interviews)
Arm Title
Group 2
Arm Description
Female veterans (focus groups and individual interviews)
Arm Title
Group 3
Arm Description
Family members of participating veterans (focus groups and individual interviews)
Primary Outcome Measure Information:
Title
Qualitative Interviews - Perspectives on Family Involvement in PTSD Treatment
Description
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.
Time Frame
During the 1-1.5 hour interviews

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Veteran: Age 18-65; 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; Served in Iraq or Afghanistan since 10/7/01; Have a family member who may be willing to participate in the focus group. Family: Age > 18 English speaking Be the designated "family member" of a participating veteran Exclusion Criteria: Non-English speaking
Study Population Description
Veteran participants were OIF/OEF veterans receiving outpatient treatment for PTSD at the Little Rock or Oklahoma City VAMCs. Each veteran participant was asked to designate an adult family member/friend to participate in a separate interview.
Sampling Method
Non-Probability Sample
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ellen P. Fischer, PhD
Organizational Affiliation
Central Arkansas Veterans Healthcare System (North Little Rock)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR
City
No. Little Rock
State/Province
Arkansas
ZIP/Postal Code
72114-1706
Country
United States
Facility Name
VA Medical Center, Oklahoma City
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States

12. IPD Sharing Statement

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Family Involvement in Treatment for PTSD

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