NCT00908440

Brief Summary

The purpose of this study is to examine the effects of a decision aid on veterans with posttraumatic stress disorder (PTSD) presenting for care. The investigators' primary hypothesis is that patients assigned to use the decision aid will demonstrate improved quality of decisions regarding PTSD treatment relative to patients assigned to usual care. Improved decision quality will be examined by assessing patient's knowledge of treatments, evaluation of the risk and benefits, ability to arrive at a decision, and certainty about that decision. The investigators' secondary hypothesis is that patients assigned to the decision aid will be more satisfied with their care and more compliant with their care compared to patients assigned to receive usual care. The investigators will also determine whether patients assigned to the decision aid, relative to patients assigned to usual care, are more likely to receive evidence-based treatments for PTSD and experience reductions in PTSD symptoms.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
132

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

May 20, 2009

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 25, 2009

Completed
7 days until next milestone

Study Start

First participant enrolled

June 1, 2009

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

May 25, 2009

Status Verified

May 1, 2009

Enrollment Period

3.6 years

First QC Date

May 20, 2009

Last Update Submit

May 22, 2009

Conditions

Posttraumatic Stress Disorder

Keywords

Decision AidPosttraumatic Stress Disorderevidence-based treatments

Outcome Measures

Primary Outcomes (3)

  • Knowledge of treatments, evaluation of the risk and benefits, as assessed by the Knowledge Questionnaire

    1 week

  • Ability to arrive at a decision and certainty about that decision, score on the Decisional Conflict Scale

    1 week

  • Satisfaction with care and compliance with care, score on the Survey of Health Experiences

    1 week

Secondary Outcomes (1)

  • Use of evidence based treatments and overall cost

    6 months

Interventions

Decision AidBEHAVIORAL

25 page booklet informing patients about PTSD symptoms and treatment options

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Veterans who meet criteria for Posttraumatic Stress Disorder on the Posttraumatic Stress Disorder Checklist (PCL).

You may not qualify if:

  • Patients must not have active substance abuse.
  • Patients must not have received VA PTSD treatment within the last 12 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

White River Junction VAMC

White River Junction, Vermont, 05009, United States

Location

Related Publications (5)

  • Foa, E.B., Keane, TM, Friedman, M.J. (eds): Effective treatments for PTSD: Practice guidelines from the International Society for Traumatic Stress Studies. NY, Guilford, 2000.

    BACKGROUND

  • Watts, B., Mayo, L., Weeks, W. A meta analysis of treatments for posttraumatic stress disorder, in International Society for Traumatic Stress Studies 21st Annual meeting. Toronto, Canada, 2005.

    BACKGROUND

  • O'Connor AM, Stacey D, Entwistle V, Llewellyn-Thomas H, Rovner D, Holmes-Rovner M, Tait V, Tetroe J, Fiset V, Barry M, Jones J. Decision aids for people facing health treatment or screening decisions. Cochrane Database Syst Rev. 2003;(2):CD001431. doi: 10.1002/14651858.CD001431.

    PMID: 12804407BACKGROUND

  • Rosen CS, Chow HC, Finney JF, Greenbaum MA, Moos RH, Sheikh JI, Yesavage JA. VA practice patterns and practice guidelines for treating posttraumatic stress disorder. J Trauma Stress. 2004 Jun;17(3):213-22. doi: 10.1023/B:JOTS.0000029264.23878.53.

    PMID: 15253093BACKGROUND

  • Watts BV, Zayed MH, Llewellyn-Thomas H, Schnurr PP. Understanding and meeting information needs for patients with posttraumatic stress disorder. BMC Psychiatry. 2016 Feb 1;16:21. doi: 10.1186/s12888-016-0724-x.

    PMID: 26830930DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Decision Support Techniques

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

  • Bradley V Watts, MD, MPH

    White River Junction Veterans Affairs Medical Center

    PRINCIPAL INVESTIGATOR

  • Paula Schnurr, PHD

    White River Junction Veterans Affairs Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Maha H Zayed, PHD

CONTACT

802-295-9363Maha.Zayed@va.gov

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
FED

Study Record Dates

First Submitted

May 20, 2009

First Posted

May 25, 2009

Study Start

June 1, 2009

Primary Completion

January 1, 2013

Study Completion

January 1, 2014

Last Updated

May 25, 2009

Record last verified: 2009-05

Locations

US(1)