Increasing Engagement in PTSD Treatment Through Patient Education and Patient Choice

This study has been completed.
Sponsor:
Collaborator:
South Central VA Mental Illness Research, Education & Clinical Center
Information provided by (Responsible Party):
Juliette Mott, Michael Debakey Veterans Affairs Medical Center
ClinicalTrials.gov Identifier:
NCT01446146
First received: September 28, 2011
Last updated: July 22, 2013
Last verified: July 2013
  Purpose

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


Condition Intervention
Posttraumatic Stress Disorder (PTSD)
Behavioral: Informed decision making
Behavioral: Placebo session

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

Resource links provided by NLM:


Further study details as provided by Michael Debakey Veterans Affairs Medical Center:

Primary Outcome Measures:
  • Treatment participation [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    Trauma Recovery Program service utilization as assessed by chart review.


Secondary Outcome Measures:
  • Treatment satisfaction [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    Assessed via self-report measures (Client Satisfaction Questionnaire, Credibility/Expectancy Questionnaire) and semi-structured interview

  • Change in PTSD severity [ Time Frame: Baseline and 4 months ] [ Designated as safety issue: No ]
    Assessed by the PCL-M at baseline and 4 month follow-up


Enrollment: 27
Study Start Date: October 2011
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01446146

Locations
United States, Texas
Michael E. DeBakey VA Medical Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
Michael Debakey Veterans Affairs Medical Center
South Central VA Mental Illness Research, Education & Clinical Center
Investigators
Principal Investigator: Juliette M Mott, PhD MDVAMC, BCM, SC MIRECC
  More Information

No publications provided

Responsible Party: Juliette Mott, Principal Investigator, Michael Debakey Veterans Affairs Medical Center
ClinicalTrials.gov Identifier: NCT01446146     History of Changes
Other Study ID Numbers: H-28111
Study First Received: September 28, 2011
Last Updated: July 22, 2013
Health Authority: United States: Federal Government

Keywords provided by Michael Debakey Veterans Affairs Medical Center:
Posttraumatic Stress Disorder
PTSD Treatment
Decision making
Veterans

Additional relevant MeSH terms:
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 28, 2014