Decision Aid in Veterans With Posttraumatic Stress Disorder
|ClinicalTrials.gov 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
|Condition or disease||Intervention/treatment||Phase|
|Posttraumatic Stress Disorder||Behavioral: Decision Aid||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||132 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Double (Investigator, Outcomes Assessor)|
|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|
- Behavioral: Decision Aid
25 page booklet informing patients about PTSD symptoms and treatment options
- Knowledge of treatments, evaluation of the risk and benefits, as assessed by the Knowledge Questionnaire [ Time Frame: 1 week ]
- Ability to arrive at a decision and certainty about that decision, score on the Decisional Conflict Scale [ Time Frame: 1 week ]
- Satisfaction with care and compliance with care, score on the Survey of Health Experiences [ Time Frame: 1 week ]
- Use of evidence based treatments and overall cost [ Time Frame: 6 months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00908440
|Contact: Maha H Zayed, PHD||802-295-9363 ext 5918||Maha.Zayed@va.gov|
|United States, Vermont|
|White River Junction VAMC|
|White River Junction, Vermont, United States, 05009|
|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|