We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Increasing Engagement in PTSD Treatment Through Patient Education and Patient Choice

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01446146
Recruitment Status : Completed
First Posted : October 5, 2011
Last Update Posted : July 24, 2013
Sponsor:
Collaborator:
South Central VA Mental Illness Research, Education & Clinical Center
Information provided by (Responsible Party):
Juliette Mott, Michael Debakey Veterans Affairs Medical Center

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
Posttraumatic Stress Disorder (PTSD) Behavioral: Informed decision making Behavioral: Placebo 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Study Start Date : October 2011
Primary Completion Date : January 2013
Study Completion Date : January 2013

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.



Primary Outcome Measures :
  1. Treatment participation [ Time Frame: 4 months ]
    Trauma Recovery Program service utilization as assessed by chart review.


Secondary Outcome Measures :
  1. Treatment satisfaction [ Time Frame: 4 months ]
    Assessed via self-report measures (Client Satisfaction Questionnaire, Credibility/Expectancy Questionnaire) and semi-structured interview

  2. Change in PTSD severity [ Time Frame: Baseline and 4 months ]
    Assessed by the PCL-M at baseline and 4 month follow-up



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: October 5, 2011    Key Record Dates
Last Update Posted: July 24, 2013
Last Verified: July 2013

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

Additional relevant MeSH terms:
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders
Mental Disorders