NCT00893152

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
83

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2009

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 1, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 5, 2009

Completed
6 months until next milestone

Study Start

First participant enrolled

November 1, 2009

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
3.1 years until next milestone

Results Posted

Study results publicly available

March 23, 2015

Completed
Last Updated

April 14, 2015

Status Verified

March 1, 2015

Enrollment Period

1.9 years

First QC Date

May 1, 2009

Results QC Date

February 17, 2015

Last Update Submit

March 24, 2015

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (3)

Group 1

Male veterans (focus groups and individual interviews)

Group 2

Female veterans (focus groups and individual interviews)

Group 3

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

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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.

You may qualify if:

  • Veteran:
  • Age 18-65;
  • 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

You may not qualify if:

  • Non-English speaking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR

No. Little Rock, Arkansas, 72114-1706, United States

Location

VA Medical Center, Oklahoma City

Oklahoma City, Oklahoma, 73104, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Results Point of Contact

Title
Ellen P. Fischer, PhD
Organization
VA HSR&D Center for Mental Healthcare & Outcomes Research

Study Officials

  • Ellen P. Fischer, PhD

    Central Arkansas Veterans Healthcare System (North Little Rock)

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
observational
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 1, 2009

First Posted

May 5, 2009

Study Start

November 1, 2009

Primary Completion

October 1, 2011

Study Completion

March 1, 2012

Last Updated

April 14, 2015

Results First Posted

March 23, 2015

Record last verified: 2015-03

Locations