Increasing Engagement in PTSD Treatment Through Patient Education and Patient Choice

July 22, 2013 updated by: Juliette Mott, Michael E. DeBakey VA Medical Center
The purpose of this program is to compare two different methods of matching a Veteran to a PTSD treatment.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Posttraumatic Stress Disorder (PTSD) is a serious disorder that affects many Veterans who have had a traumatic experience. The VA offers several different types of treatment for PTSD. We are researching different ways to match a Veteran to a type of treatment. Participants in this study will will be randomly assigned to either a 40-minute session in which they will learn about PTSD treatments and select a preferred treatment or to a 40-minute assessment interview. Those participants assigned to the assessment interview will have the opportunity to work with their Trauma Recovery Program provider to determine a plan for their PTSD treatment.

Study Type

Interventional

Enrollment (Actual)

27

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • Michael E. DeBakey VA Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosis of combat-related PTSD
  • Newly enrolled in Trauma Recovery Program (TRP) at the Michael E. DeBakey VA medical center
  • TRP provider approval

Exclusion Criteria:

  • Previous participation in TRP treatment for PTSD

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: IDM intervention
Will receive a 40 minute intervention session with a clinician, learning about PTSD treatment options and choosing a preferred treatment.
Behavioral: Informed decision making
40 minute session with a clinician. Participants will learn about the available PTSD treatment options and will be given a decision aid with more information.
Placebo Comparator: Treatment as usual plus placebo session
Will work with provider to select a treatment plan and will receive a 40 minute session without IDM intervention.
Behavioral: Placebo session
Participant will complete clinician-administered measures in a 40-minute session.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment participation
Time Frame: 4 months
Trauma Recovery Program service utilization as assessed by chart review.
4 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment satisfaction
Time Frame: 4 months
Assessed via self-report measures (Client Satisfaction Questionnaire, Credibility/Expectancy Questionnaire) and semi-structured interview
4 months
Change in PTSD severity
Time Frame: Baseline and 4 months
Assessed by the PCL-M at baseline and 4 month follow-up
Baseline and 4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Michael E. DeBakey VA Medical Center

Collaborators

South Central VA Mental Illness Research, Education & Clinical Center

Investigators

  • Principal Investigator: Juliette M Mott, PhD, MDVAMC, BCM, SC MIRECC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (Actual)

January 1, 2013

Study Completion (Actual)

January 1, 2013

Study Registration Dates

First Submitted

September 28, 2011

First Submitted That Met QC Criteria

October 3, 2011

First Posted (Estimate)

October 5, 2011

Study Record Updates

Last Update Posted (Estimate)

July 24, 2013

Last Update Submitted That Met QC Criteria

July 22, 2013

Last Verified

July 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-28111

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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