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Decision Aid in Veterans With Posttraumatic Stress Disorder

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. Identifier: NCT00908440
Recruitment Status : Unknown
Verified May 2009 by White River Junction Veterans Affairs Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : May 25, 2009
Last Update Posted : May 25, 2009
Information provided by:
White River Junction Veterans Affairs Medical Center

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.

Condition or disease Intervention/treatment Phase
Posttraumatic Stress Disorder Behavioral: Decision Aid Not Applicable

Detailed Description:

Posttraumatic stress is a severe and often disabling condition affecting millions of veterans. Within VA, significant staffing and financial resources are devoted to the mission of treating PTSD and the anticipated need for treatment is expected to accelerate as veterans return from the Iraq war.

Research has identified a number of successful strategies for the treatment of PTSD, including both psychotherapy and pharmacology. Several treatments, including group psychotherapy and benzodiazepines have demonstrated a lack of efficacy in the treatment of PTSD. Despite this knowledge, many veterans with PTSD do not receive an evidence-based treatment and may even receive a treatment known to not be effective. Among the group of proven effective treatments, the patient time commitment and adverse effects differ considerably. Patients with PTSD are often ill informed about the available treatments, and there has been little formal effort aimed at matching the patients' preferences to a specific treatment.

We propose to conduct a clinical trial of a decision aid for veterans with PTSD. Decision aids are standardized, evidence-based tools to help patients choose between two or more preference-sensitive, clinically acceptable options when there is no clear "best" option. Decision aids are designed to provide patients with detailed balanced information about all the viable treatment options. In addition, they seek to assist the patient in clarifying their own values and preferences such that the patient may choose among the available treatment options.

We believe that the use of a decision aid, compared to treatment as usual, will result in a more patient-centered approach that ultimately will increase the likelihood of the patient receiving evidence based care, both of which are priority goals of VHA.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 132 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Decision Aid in Veterans With Posttraumatic Stress Disorder
Study Start Date : June 2009
Estimated Primary Completion Date : January 2013
Estimated Study Completion Date : January 2014

Resource links provided by the National Library of Medicine

Intervention Details:
  • Behavioral: Decision Aid
    25 page booklet informing patients about PTSD symptoms and treatment options

Primary Outcome Measures :
  1. Knowledge of treatments, evaluation of the risk and benefits, as assessed by the Knowledge Questionnaire [ Time Frame: 1 week ]
  2. Ability to arrive at a decision and certainty about that decision, score on the Decisional Conflict Scale [ Time Frame: 1 week ]
  3. Satisfaction with care and compliance with care, score on the Survey of Health Experiences [ Time Frame: 1 week ]

Secondary Outcome Measures :
  1. Use of evidence based treatments and overall cost [ Time Frame: 6 months ]

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.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

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

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 identifier (NCT number): NCT00908440

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Contact: Maha H Zayed, PHD 802-295-9363 ext 5918

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United States, Vermont
White River Junction VAMC
White River Junction, Vermont, United States, 05009
Sponsors and Collaborators
White River Junction Veterans Affairs Medical Center
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Principal Investigator: Bradley V Watts, MD, MPH White River Junction Veterans Affairs Medical Center
Principal Investigator: Paula Schnurr, PHD White River Junction Veterans Affairs Medical Center
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.
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.
O'Connor, A., Stacey, D., Entwistle, V., Llewellyn-Thomas, H., Rovner, D., Holmes-Rovner, M., Tetroe, J., Fiset, V., Barry, M., Jones, J. Decision aids for people facing health treatment or screen decisions. The Cochrane Library 2003 (2): 1-98.

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Bradley Vince Watts, MD, MPH, White River Junction VAMC Identifier: NCT00908440    
Other Study ID Numbers: IIR 07-266
First Posted: May 25, 2009    Key Record Dates
Last Update Posted: May 25, 2009
Last Verified: May 2009
Keywords provided by White River Junction Veterans Affairs Medical Center:
Decision Aid
Posttraumatic Stress Disorder
evidence-based treatments
Additional relevant MeSH terms:
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Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Pathologic Processes
Trauma and Stressor Related Disorders
Mental Disorders