Clinical trial NCT02917447: Evaluation of Web-Based CBT for Women Veterans With PTSD
Official title: Evaluation of Web-Based CBT for Women Veterans With PTSD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: PTSD
Keywords: PTSD
Women Veterans
Online intervention
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2016-09-28
Enrollment: 102
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Respondents who do not meet eligibility criteria will be offered a resource list, referred for treatment, and/or be further assessed for suicidality as appropriate. For those who are eligible, contact information (e.g., address, telephone number) and contact information for at least one friend or family member who typically would know the whereabouts of the participant should study staff have difficulty making contact will be recorded. Eligible patients will be invited to complete a baseline online survey.

Baseline and follow-up online surveys (60-90 minutes). The baseline and follow-up surveys (at post-treatment and 12- and 24-week follow-ups) consist of an online survey. Each online survey takes 60-90 minutes to complete. Participants will be compensated for the baseline survey, for each of the follow-up surveys, and a bonus for completing all surveys. If the interval between the eligibility interview and baseline survey is longer than four weeks, we will require re-administration of CAPS via telephone to ensure PTSD status. Participants will be given one-week and one-day reminders to complete the survey. Following completion of the baseline survey, participants will be randomly assigned to one of the conditions.

Randomization scheme. Fifty participants will be randomized to the adapted, web-based intervention and 50 to phone monitoring only. Participants will be randomized following their completion of the baseline survey. Stratification of randomization by rural status will be done to facilitate exploratory analyses of the impact of this variable on trial outcomes. Following randomization, the study coach will arrange an initial telephone session with each participant.

Study conditions. The treatment phase for both study conditions will last 8 weeks; however, participants will have up to 12 weeks to complete the intervention and complete study coach calls, if needed.

Phone monitoring condition. Participants randomized to the phone monitoring condition will receive calls from a study coach once a week for 8 weeks for approximately 10-15 minutes. The coach will assess their PTSD symptoms and safety.

DESTRESS-WV. Those randomly assigned to the web-based intervention will also receive calls from a study coach once a week for 8 weeks to assess PTSD symptoms and safety; the coach will also review the participant's progress with the DESTRESS-WV website. Participants will be instructed to log-on to the website twice per week, with each session taking approximately 30-60 minutes. The web-based intervention consists of 16 sessions involving structured, cognitive-behavioral components, including cognitive restructuring and in-vivo and imaginal exposure. Participants will be reminded of the study office phone number as well as the Veterans Crisis Line phone number at every logon.

Eligibility 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

Primary outcomes:
measure: Change in PTSD Checklist (PCL-5)
timeFrame: Baseline, Post-treatment (8-12 weeks after baseline), 3-months post-treatment, 6-months post-treatment
Secondary outcomes:
measure: Change in Patient Health Questionnaire-8 (PHQ-8)
timeFrame: Baseline, Post-treatment (8-12 weeks after baseline), 3-months post-treatment, 6-months post-treatment
measure: Change in the Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form
timeFrame: Baseline, Post-treatment (8-12 weeks after baseline), 3-months post-treatment, 6-months post-treatment
Other outcomes:
Locations:
city: Seattle
country: United States
facility: VA Puget Sound Health Care System Seattle Division, Seattle, WA
state: Washington
Study officials:
affiliation: VA Puget Sound Health Care System Seattle Division, Seattle, WA
name: Keren Lehavot, PhD MS BA
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.