Increasing Engagement in PTSD Treatment Through Patient Education and Patient Choice

Sponsor

Michael E. DeBakey VA Medical Center (U.S. Fed)

Overall Status

Completed

CT.gov ID

NCT01446146

Collaborator

South Central VA Mental Illness Research, Education & Clinical Center (U.S. Fed)

Enrollment

Location

Arms

Duration (Months)

1.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Posttraumatic Stress Disorder (PTSD)	Behavioral: Informed decision making Behavioral: Placebo session	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

27 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

Study Start Date :

Oct 1, 2011

Actual Primary Completion Date :

Jan 1, 2013

Actual Study Completion Date :

Jan 1, 2013

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Treatment participation [4 months]
Trauma Recovery Program service utilization as assessed by chart review.

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Michael E. DeBakey VA Medical Center	Houston	Texas	United States	77030

Sponsors and Collaborators

Michael E. DeBakey VA Medical Center
South Central VA Mental Illness Research, Education & Clinical Center

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Juliette Mott, Principal Investigator, Michael E. DeBakey VA Medical Center

ClinicalTrials.gov Identifier:

NCT01446146

Other Study ID Numbers:

H-28111

First Posted:

Oct 5, 2011

Last Update Posted:

Jul 24, 2013

Last Verified:

Jul 1, 2013

Keywords provided by Juliette Mott, Principal Investigator, Michael E. DeBakey VA Medical Center

Posttraumatic Stress Disorder

PTSD Treatment

Decision making

Veterans

Additional relevant MeSH terms:

Stress Disorders, Traumatic

Stress Disorders, Post-Traumatic

Study Results

No Results Posted as of Jul 24, 2013