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Evaluation of Web-Based CBT for Women Veterans With PTSD

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ClinicalTrials.gov Identifier: NCT02917447
Recruitment Status : Active, not recruiting
First Posted : September 28, 2016
Last Update Posted : June 5, 2019
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Brief Summary:
The purpose of this study is to evaluate an online PTSD intervention that was adapted for women Veterans, called DElivery of Self TRaining and Education for Stressful Situations-Women Veterans version (DESTRESS-WV). The intervention consists of structured online sessions as well as weekly brief phone calls for additional support with a study coach. Women Veterans with PTSD who are eligible will be randomized to receive either DESTRESS-WV or phone monitoring only for 8 weeks. Participants will be assessed immediately post-treatment as well as at 12 and 24 weeks post-treatment. Investigators hypothesize that participants randomly assigned to DESTRESS-WV will have a greater decrease in severity of PTSD symptoms compared to those randomly assigned to phone monitoring only.

Condition or disease Intervention/treatment Phase
PTSD Behavioral: DESTRESS-WV Behavioral: Phone Monitoring Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 102 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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

Arm Intervention/treatment
Experimental: DESTRESS-WV
Tailored online intervention for PTSD for women Veterans with coach support.
Behavioral: DESTRESS-WV

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.




Primary Outcome Measures :
  1. Change in PTSD Checklist (PCL-5) [ Time Frame: Baseline, 8-16 weeks, 20-28 weeks, 32-40 weeks ]
    PTSD symptoms


Secondary Outcome Measures :
  1. Change in Patient Health Questionnaire-8 (PHQ-8) [ Time Frame: Baseline, 8-16 weeks, 20-28 weeks, 32-40 weeks ]
    Depressive symptoms

  2. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Study is focused on cisgender women.
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age 18 or older
  • female
  • Veteran of the US military
  • current PTSD
  • reports routine access to computer and Internet
  • willing to provide at least one collateral contact
  • willing to allow investigators to leave phone messages pertaining to the study
  • willing to be audio-taped during assessments and study coach calls

Exclusion Criteria:

  • actively engaged in individual therapy in the past two months, or receiving couple's or group therapy in the past two months that focuses on PTSD
  • scheduled to receive a future individual therapy appointment or future couples' or group therapy appointment focused on PTSD at a frequency of once per month or more
  • active suicidal or violent ideation within the past two months or on the VA "high risk" list for imminent danger to self or others
  • moderate or extreme substance use disorder in the past year
  • acute psychosis, psychotic episode, or psychotic disorder diagnosis within the past year
  • unstable administration schedule or dosing of any antidepressant, anxiolytic, or sedative-hypnotic

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 ClinicalTrials.gov identifier (NCT number): NCT02917447


Locations
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United States, Washington
VA Puget Sound Health Care System Seattle Division, Seattle, WA
Seattle, Washington, United States, 98108
Sponsors and Collaborators
VA Office of Research and Development
Investigators
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Principal Investigator: Keren Lehavot, PhD MS BA VA Puget Sound Health Care System Seattle Division, Seattle, WA

Publications of Results:
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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT02917447     History of Changes
Other Study ID Numbers: MHBA-021-13SB
IK2CX000867-01 ( U.S. NIH Grant/Contract )
First Posted: September 28, 2016    Key Record Dates
Last Update Posted: June 5, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by VA Office of Research and Development:
PTSD
Women Veterans
Online intervention