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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01073657
Other study ID # PPO 09-254
Secondary ID
Status Completed
Phase Phase 0
First received February 18, 2010
Last updated April 6, 2015
Start date November 2011
Est. completion date August 2012

Study information

Verified date September 2014
Source VA Office of Research and Development
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

The goal of this project is to gather data necessary for a full scale trial of a supported education service for OIF/OEF veterans with PTSD. Forty Veterans with PTSD will be randomly assigned to an intervention group (N=20) that receives a weekly supported education intervention and a control group that receives services as usual plus an hour of attentive intervention not focused on education. We will assess and compare the number of hours of participation in community education settings and on acquiring an educational goal for the Veterans in each group.


Description:

Goal: The goal of this project is to gather data on feasibility and effect size necessary for a full scale trial of a supported education service for Operation Iraq and Enduring Freedom (OIF/OEF) veterans with PTSD that will contribute to its evidence-base. Supported education is a rehabilitation and recovery based intervention that is new to VHA services and that responds to an expressed but unmet need among these warriors with war-related trauma. We propose to conduct a pilot of a supported education service and employ a process and outcome evaluation.

Anticipated Impacts on Veterans Healthcare: Veterans with post traumatic stress disorder (PTSD) possess educational aspirations. Due to limited education and disability adjustment, many such veterans unsuccessfully locate employment or obtain entry level jobs with limited advancement opportunities. Even with current GI Bill funding increases, veterans experience non-financial barriers to their pursuit of educational goals. Supported education is a strategy developed within the civilian population that facilitates skill, career, and educational goals within post-secondary educational settings. It has been shown to increase educational engagement, participation, and completion, as well as improve empowerment and school efficacy. We hypothesize that supported education tailored to returning Veterans will result in similar outcomes.

Aims and Objectives: The goal of this project is to gather data necessary for a full scale trial of a supported education service for OIF/OEF veterans with PTSD. The following are the aims and objectives:

Aim 1: Using a randomized controlled design, assess the magnitude of the effect of a supported education service on hours of participation in community educational settings and on acquiring an educational goal. Objective: Assess the number of hours of participation in community education settings and on acquiring an educational goal for 40 Veterans with PTSD who are randomly assigned to an intervention group (N=20) that receives a weekly supported education intervention and a control group that receives services as usual plus an hour of attentive intervention not focused on education.

Aim 2. To examine whether the supported education intervention has secondary effects for improving PTSD symptoms and attitudes on recovery. Objective: Conduct pre- and post assessments of recovery attitudes and of PTSD symptoms, and then compare the control and intervention group for changes in these scores.

Aim 3. To acquire additional process information on the design and implementation of a supported education service necessary for a successful larger trial. Objective: Conduct a process evaluation of the implementation strategies for: participant recruitment, participant drop-out, technician training procedures, technician recovery promoting competence, and curriculum content and pacing using a standardized assessment, exit interviews, peer notes and study records.


Recruitment information / eligibility

Status Completed
Enrollment 33
Est. completion date August 2012
Est. primary completion date August 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- PTSD

- OIF/OEF Service

Exclusion Criteria:

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Other:
Supported Education
Rehabilitation counseling using peers to achieve educational goals
General Peer Support
Matched peer support for any personal goal other than education

Locations

Country Name City State
United States Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA Bedford Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (1)

Ellison ML, Mueller L, Smelson D, Corrigan PW, Torres Stone RA, Bokhour BG, Najavits LM, Vessella JM, Drebing C. Supporting the education goals of post-9/11 veterans with self-reported PTSD symptoms: a needs assessment. Psychiatr Rehabil J. 2012 Winter;35 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary "Supported Education Process Measure" Number of quarter hours spent in activities related to acquiring an education goal e.g., preparing applications, attending classes. Hours will be logged on a tally sheet adapted from the "Supported Education Process Measure" (Corrigan, 2009). 6 months No
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