NCT02917447

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
102

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

July 5, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 23, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 28, 2016

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 28, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 28, 2019

Completed
11 months until next milestone

Results Posted

Study results publicly available

May 11, 2020

Completed
Last Updated

May 11, 2020

Status Verified

April 1, 2020

Enrollment Period

3 years

First QC Date

September 23, 2016

Results QC Date

April 9, 2020

Last Update Submit

April 29, 2020

Conditions

PTSD

Keywords

PTSDWomen VeteransOnline intervention

Outcome Measures

Primary Outcomes (1)

  • Change in PTSD Checklist (PCL-5)

    The PTSD Symptom-Checklist -Version 5 (PCL-5) is a 20-item, self-report instrument that assesses the presence and severity of DSM-V PTSD symptoms in the last month. It was summed for a total severity score ranging from 0-80, with higher scores representing greater symptom severity. Changes from baseline at three separate times post-baseline are reported for each treatment group. These calculations are based on marginal means estimated from a linear mixed model analysis with PCL as the dependent variable; rural status, MST history, study assessment, treatment group, and study assessment by treatment group interaction as the independent fixed effects; and study participant as a random effect.

    Baseline, Post-treatment (8-12 weeks after baseline), 3-months post-treatment, 6-months post-treatment

Secondary Outcomes (2)

  • Change in Patient Health Questionnaire-8 (PHQ-8)

    Baseline, Post-treatment (8-12 weeks after baseline), 3-months post-treatment, 6-months post-treatment

  • Change in the Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form

    Baseline, Post-treatment (8-12 weeks after baseline), 3-months post-treatment, 6-months post-treatment

Study Arms (2)

DESTRESS-WV

EXPERIMENTAL

Tailored online intervention for PTSD for women Veterans with coach support.

Behavioral: DESTRESS-WV

Phone Monitoring

PLACEBO COMPARATOR

Weekly check-in calls from a study coach.

Behavioral: Phone Monitoring

Interventions

DESTRESS-WVBEHAVIORAL

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. 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 program.

DESTRESS-WV
Phone MonitoringBEHAVIORAL

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.

Phone Monitoring

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsStudy is focused on cisgender women.
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Puget Sound Health Care System Seattle Division, Seattle, WA

Seattle, Washington, 98108, United States

Location

Related Publications (7)

  • Lehavot K, Litz B, Millard SP, Hamilton AB, Sadler A, Simpson T. Study adaptation, design, and methods of a web-based PTSD intervention for women Veterans. Contemp Clin Trials. 2017 Feb;53:68-79. doi: 10.1016/j.cct.2016.12.002. Epub 2016 Dec 8.

    PMID: 27940187BACKGROUND

  • Engel CC, Litz B, Magruder KM, Harper E, Gore K, Stein N, Yeager D, Liu X, Coe TR. Delivery of self training and education for stressful situations (DESTRESS-PC): a randomized trial of nurse assisted online self-management for PTSD in primary care. Gen Hosp Psychiatry. 2015 Jul-Aug;37(4):323-8. doi: 10.1016/j.genhosppsych.2015.04.007. Epub 2015 Apr 13.

    PMID: 25929985BACKGROUND

  • Litz BT, Engel CC, Bryant RA, Papa A. A randomized, controlled proof-of-concept trial of an Internet-based, therapist-assisted self-management treatment for posttraumatic stress disorder. Am J Psychiatry. 2007 Nov;164(11):1676-83. doi: 10.1176/appi.ajp.2007.06122057.

    PMID: 17974932BACKGROUND

  • Lehavot K, Katon JG, Chen JA, Fortney JC, Simpson TL. Post-traumatic Stress Disorder by Gender and Veteran Status. Am J Prev Med. 2018 Jan;54(1):e1-e9. doi: 10.1016/j.amepre.2017.09.008.

    PMID: 29254558RESULT

  • Chen JA, Shofer J, Barnes ML, Livingston WS, Upham M, Simpson TL. Military Sexual Trauma As a Risk Factor for Treatment Non-Response from an Online, Self-Management Posttraumatic Stress Disorder Treatment for Women Veterans. J Interpers Violence. 2024 May;39(9-10):2214-2237. doi: 10.1177/08862605231216722. Epub 2023 Dec 11.

    PMID: 38073465DERIVED

  • Simon N, Robertson L, Lewis C, Roberts NP, Bethell A, Dawson S, Bisson JI. Internet-based cognitive and behavioural therapies for post-traumatic stress disorder (PTSD) in adults. Cochrane Database Syst Rev. 2021 May 20;5(5):CD011710. doi: 10.1002/14651858.CD011710.pub3.

    PMID: 34015141DERIVED

  • Lehavot K, Millard SP, Thomas RM, Yantsides K, Upham M, Beckman K, Hamilton AB, Sadler A, Litz B, Simpson T. A randomized trial of an online, coach-assisted self-management PTSD intervention tailored for women veterans. J Consult Clin Psychol. 2021 Feb;89(2):134-142. doi: 10.1037/ccp0000556.

    PMID: 33705169DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Results Point of Contact

Title
Keren Lehavot, PhD
Organization
VA Puget Sound Health Care System
keren.lehavot@va.gov
206-277-1511

Study Officials

  • Keren Lehavot, PhD MS BA

    VA Puget Sound Health Care System Seattle Division, Seattle, WA

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 23, 2016

First Posted

September 28, 2016

Study Start

July 5, 2016

Primary Completion

June 28, 2019

Study Completion

June 28, 2019

Last Updated

May 11, 2020

Results First Posted

May 11, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)