Evaluation of Web-Based CBT for Women Veterans With PTSD
|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.|
|ClinicalTrials.gov Identifier: NCT02917447|
Recruitment Status : Active, not recruiting
First Posted : September 28, 2016
Last Update Posted : June 5, 2019
|Condition or disease||Intervention/treatment||Phase|
|PTSD||Behavioral: DESTRESS-WV Behavioral: Phone Monitoring||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||102 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Evaluation of Web-Based CBT for Women Veterans With PTSD|
|Actual Study Start Date :||July 5, 2016|
|Estimated Primary Completion Date :||July 26, 2019|
|Estimated Study Completion Date :||July 26, 2019|
Tailored online intervention for PTSD for women Veterans with coach support.
This is an online intervention for PTSD tailored for women Veterans. The intervention is based on cognitive behavioral therapy (CBT). The goal of CBT is to help people recognize and address their thoughts and behaviors in positive ways with the aim of improving their ability to function as well as possible in their lives.
Participants will be asked to log on to the website twice per week for about 30-60 minutes each time. On two occasions, participants will be asked to write about current stressors or hassles. Additionally, on two occasions participants will be asked to write about a traumatic experience and then rewrite it. Participants will be guided in using various coping skills taught in the program during this writing process. Homework assignments will include stress management skills that participants will be asked to practice and apply. A study coach will call each participant once a week for 8 weeks for about 15 minutes to review their progress with the prog
Placebo Comparator: Phone Monitoring
Weekly check-in calls from a study coach.
Behavioral: Phone Monitoring
A study coach will call participants once a week for 8 weeks for approximately 15 minutes. The coach will assess participants' PTSD symptoms and safety. She will encourage participants to use the time on the call to discuss any current life issues or problems that they would like. Active listening and rephrasing will be used, while teaching cognitive-behavioral strategies will be avoided.
- Change in PTSD Checklist (PCL-5) [ Time Frame: Baseline, 8-16 weeks, 20-28 weeks, 32-40 weeks ]PTSD symptoms
- Change in Patient Health Questionnaire-8 (PHQ-8) [ Time Frame: Baseline, 8-16 weeks, 20-28 weeks, 32-40 weeks ]Depressive symptoms
- Change in the Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form [ Time Frame: Baseline, 8-16 weeks, 20-28 weeks, 32-40 weeks ]Quality of life
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 ClinicalTrials.gov identifier (NCT number): NCT02917447
|United States, Washington|
|VA Puget Sound Health Care System Seattle Division, Seattle, WA|
|Seattle, Washington, United States, 98108|
|Principal Investigator:||Keren Lehavot, PhD MS BA||VA Puget Sound Health Care System Seattle Division, Seattle, WA|