Increasing Engagement in PTSD Treatment Through Patient Education and Patient Choice

Posttraumatic Stress Disorder (PTSD) Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01446146
• Other study ID #: H-28111
• Status: Completed
• Phase: N/A
• First received: September 28, 2011
• Last updated: July 22, 2013
• Start date: October 2011
• Est. completion date: January 2013

Study information

• Verified date: July 2013
• Source: Michael Debakey Veterans Affairs Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

The purpose of this program is to compare two different methods of matching a Veteran to a PTSD treatment.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Posttraumatic Stress Disorder (PTSD)
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

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 session
Participant will complete clinician-administered measures in a 40-minute session.

Locations

Country	Name	City	State
United States	Michael E. DeBakey VA Medical Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Michael Debakey Veterans Affairs Medical Center	South Central VA Mental Illness Research, Education & Clinical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment participation	Trauma Recovery Program service utilization as assessed by chart review.	4 months	No
Secondary	Treatment satisfaction	Assessed via self-report measures (Client Satisfaction Questionnaire, Credibility/Expectancy Questionnaire) and semi-structured interview	4 months	No
Secondary	Change in PTSD severity	Assessed by the PCL-M at baseline and 4 month follow-up	Baseline and 4 months	No