Back to resultsIncreasing Engagement in PTSD Treatment Through Patient Education and Patient Choice
Primary Purpose
Posttraumatic Stress Disorder (PTSD)
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Informed decision making
Placebo session
Sponsored by
About this trial
This is an interventional health services research trial for Posttraumatic Stress Disorder (PTSD) focused on measuring Posttraumatic Stress Disorder, PTSD Treatment, Decision making, Veterans
Eligibility 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
Sites / Locations
- Michael E. DeBakey VA Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
IDM intervention
Treatment as usual plus placebo session
Arm Description
Will receive a 40 minute intervention session with a clinician, learning about PTSD treatment options and choosing a preferred treatment.
Will work with provider to select a treatment plan and will receive a 40 minute session without IDM intervention.
Outcomes
Primary Outcome Measures
Treatment participation
Trauma Recovery Program service utilization as assessed by chart review.
Secondary Outcome Measures
Treatment satisfaction
Assessed via self-report measures (Client Satisfaction Questionnaire, Credibility/Expectancy Questionnaire) and semi-structured interview
Change in PTSD severity
Assessed by the PCL-M at baseline and 4 month follow-up
Full Information
NCT ID
NCT01446146
First Posted
September 28, 2011
Last Updated
July 22, 2013
Sponsor
Michael E. DeBakey VA Medical Center
Collaborators
South Central VA Mental Illness Research, Education & Clinical Center
1. Study Identification
Unique Protocol Identification Number
NCT01446146
Brief Title
Increasing Engagement in PTSD Treatment Through Patient Education and Patient Choice
Study Type
Interventional
2. Study Status
Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
January 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Michael E. DeBakey VA Medical Center
Collaborators
South Central VA Mental Illness Research, Education & Clinical Center
4. Oversight
5. Study Description
Brief Summary
The purpose of this program is to compare two different methods of matching a Veteran to a PTSD 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Posttraumatic Stress Disorder (PTSD)
Keywords
Posttraumatic Stress Disorder, PTSD Treatment, Decision making, Veterans
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
27 (Actual)
8. Arms, Groups, and Interventions
Arm Title
IDM intervention
Arm Type
Experimental
Arm Description
Will receive a 40 minute intervention session with a clinician, learning about PTSD treatment options and choosing a preferred treatment.
Arm Title
Treatment as usual plus placebo session
Arm Type
Placebo Comparator
Arm Description
Will work with provider to select a treatment plan and will receive a 40 minute session without IDM intervention.
Intervention Type
Behavioral
Intervention Name(s)
Informed decision making
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Placebo session
Intervention Description
Participant will complete clinician-administered measures in a 40-minute session.
Primary Outcome Measure Information:
Title
Treatment participation
Description
Trauma Recovery Program service utilization as assessed by chart review.
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Treatment satisfaction
Description
Assessed via self-report measures (Client Satisfaction Questionnaire, Credibility/Expectancy Questionnaire) and semi-structured interview
Time Frame
4 months
Title
Change in PTSD severity
Description
Assessed by the PCL-M at baseline and 4 month follow-up
Time Frame
Baseline and 4 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juliette M Mott, PhD
Organizational Affiliation
MDVAMC, BCM, SC MIRECC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Michael E. DeBakey VA Medical Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
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Increasing Engagement in PTSD Treatment Through Patient Education and Patient Choice
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