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Clinical Trials/NCT02917447
NCT02917447CompletedNot Applicable

Evaluation of Web-Based CBT for Women Veterans With PTSD

VA Office of Research and Development2 sites in 1 country102 target enrollmentStarted: July 5, 2016Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
102
Locations
2
Primary Endpoint
Change in PTSD Checklist (PCL-5)

Study Overview

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.

Detailed Description

The RCT will target women Veterans with PTSD to compare the adapted, web-based intervention to phone monitoring only. Participants will include women Veterans with PTSD who are not actively receiving PTSD treatment. They will be interviewed via phone for an initial phone screening and eligibility interview and will complete additional online surveys at baseline, post-treatment, and 12-, and 24-week follow-up.

Recruitment. Women Veterans who live in Pacific or Mountain Time Zones with an ICD code for PTSD or a positive VA mandated PTSD screen, with no mental health stop-code in the last 2 months, and who are not on the high risk list for imminent danger to self or others, will be identified using a VINCI data pull. Individuals with these criteria will be mailed up to two invitation letters and a brochure describing the study inviting them to contact the study office. If women do not contact the study office to opt out of the study, the investigators may call them to follow-up. The investigators aim to obtain a sample of 100 individuals that meet study inclusion/exclusion criteria after providing informed consent. Because the investigators aim to recruit participants for approximately 24 months, the investigators will aim to enroll and randomize 4-5 participants per month.

Procedure. The RCT will involve four assessment phases: initial phone screen to ascertain interest and basic inclusion/exclusion eligibility, assessment of diagnostic eligibility in a full eligibility interview, baseline survey of outcomes of interest prior to initiating treatment, and three follow-up surveys of outcomes of interest at post-treatment and 12- and 24-weeks post-treatment. Patients will be randomized to condition following completion of the baseline online survey. The eligibility interview and study coach phone calls will be audio-recorded to ensure adherence to the study protocol.

Phone screen (10-15 minutes). When interested women Veterans contact the study office, study personnel will provide an overview of the study and, for those still interested, conduct an initial pre-consent screening. The purpose of the pre-consent eligibility screening is to quickly determine which candidates are most likely to qualify, thus eliminating the need to conduct consent and full eligibility interviews for those who are unlikely to meet study criteria. If patients are found to be eligible following the pre-consent eligibility screening, study staff will review the consent process, including willingness to be audio-taped during assessments and study coach calls, answer any questions, and mail the consent form to the participant to obtain written consent, along with a demographic form and Life Events Checklist. The full eligibility interview will be scheduled at this time but will only be conducted if and when the signed, written informed consent, HIPAA form, demographic form, and Life Events Checklist have been received in the study office.

Eligibility interview (95-150 minutes). Study personnel will call the potential study participant to conduct the eligibility interview over the phone after written, informed consent has been received in the study office. The interview will assess current PTSD as addressed by the CAPS interview as well as various exclusion criteria. During the course of the interview, if study personnel are concerned about the fit of the study for the potential participant, they will discuss with the PI. Potential participants who are of concern and may show a high risk profile (e.g., multiple past suicide attempts, inpatient hospitalizations, lifetime psychotic disorders) or prominent disorganization while on the phone will be discussed by the PI and co-investigator Dr. Simpson for possible exclusion.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • age 18 or older
  • 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

Outcomes

Primary Outcomes

Change in PTSD Checklist (PCL-5)

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

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.

Secondary Outcomes

  • 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)

Investigators

Sponsor Class
Fed
Responsible Party
Sponsor

Study Sites (2)

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