NCT01446146

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 28, 2011

Completed
3 days until next milestone

Study Start

First participant enrolled

October 1, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 5, 2011

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

July 24, 2013

Status Verified

July 1, 2013

Enrollment Period

1.3 years

First QC Date

September 28, 2011

Last Update Submit

July 22, 2013

Conditions

Posttraumatic Stress Disorder (PTSD)

Keywords

Posttraumatic Stress DisorderPTSD TreatmentDecision makingVeterans

Outcome Measures

Primary Outcomes (1)

  • Treatment participation

    Trauma Recovery Program service utilization as assessed by chart review.

    4 months

Secondary Outcomes (2)

  • Treatment satisfaction

    4 months

  • Change in PTSD severity

    Baseline and 4 months

Study Arms (2)

IDM intervention

EXPERIMENTAL

Will receive a 40 minute intervention session with a clinician, learning about PTSD treatment options and choosing a preferred treatment.

Behavioral: Informed decision making

Treatment as usual plus placebo session

PLACEBO COMPARATOR

Will work with provider to select a treatment plan and will receive a 40 minute session without IDM intervention.

Behavioral: Placebo session

Interventions

Informed decision makingBEHAVIORAL

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.

IDM intervention
Placebo sessionBEHAVIORAL

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

Treatment as usual plus placebo session

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of combat-related PTSD
  • Newly enrolled in Trauma Recovery Program (TRP) at the Michael E. DeBakey VA medical center
  • TRP provider approval

You may not qualify if:

  • Previous participation in TRP treatment for PTSD

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Michael E. DeBakey VA Medical Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Officials

  • Juliette M Mott, PhD

    MDVAMC, BCM, SC MIRECC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 28, 2011

First Posted

October 5, 2011

Study Start

October 1, 2011

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

July 24, 2013

Record last verified: 2013-07

Locations

US(1)