Clinical trial NCT04286165: Brief Peer Supported webSTAIR Compared to Enhanced Wait List
Official title: A Randomized Controlled Trial Comparing Brief Peer Supported webSTAIR to Enhanced Wait List
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post Traumatic Stress Disorder
Depression
Emotion Regulation
Keywords: PTSD
Post Traumatic Stress Disorder
Depression
Emotion Regulation
Skills Building
Peer
Coaching
Online
Lead sponsor: Palo Alto Veterans Institute for Research
Sponsor class: OTHER
First posted: 2020-02-26
Enrollment: 178
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will enroll 180 Veterans at a 2:1 ratio where 120 Veterans will be enrolled into a brief transdiagnostic peer supported webSTAIR (BPS webSTAIR) and 60 will be supported into Waitlist. The purpose of the study is to assess the efficacy BPS webSTAIR in regard to four outcomes: reduction in PTSD and depression symptoms (measured by the PCL-5 and PHQ-8, respectively) and improvement in emotion regulation and work and social adjustment (measured by the DERS-16 and WSAS, respectively). The active treatment is a 6-session modular treatment that focuses on learning emotion management skills where Particpants will have 10 weeks to complete the treatment. Assessments will occur three times for those in webSTAIR: baseline, post-treatment (10 weeks after randomization) and 8-week follow-up and twice for those on waitlist (baseline and 10 weeks after randomization). It is hypothesized that BPS WebSTAIR will be superior to the Waitlist condition on all four outcomes. Mixed Effects Models will be used to evaluate the outcomes.

Detailed description: The purpose of this randomized controlled trial is to assess the efficacy of a brief version of webSTAIR (BPS webSTAIR) supported by peers compared to a waitlist condition (WL). Brief peer supported (BPS) webSTAIR is a 6-module web-based transdiagnostic program that provides skills training in emotion regulation; participants in this condition will be able to contact a Veteran peer trained in the program to obtain general support plus guidance about program use and application of skills.

An 11-module version of webSTAIR with therapist coaching has provided pilot data that the program is effective in reducing symptoms of posttraumatic stress disorder (PTSD) and depression as well as improving emotion regulation and work and social adjustment. Pilot data indicate that initial gains are made in the first 6 sessions. In addition, qualitative interviews with Veterans who have completed the program indicate high satisfaction with these modules. This study will assess whether a shorter version of the treatment (6 rather than 11 modules) and with peer rather than professional coaching will be effective compared to a waitlist condition. The BPS webSTAIR program was developed with the aim of providing a treatment for trauma-related symptoms that is effective, brief, engaging and likely to be completed by the user. The reduction of the number of modules creates a briefer treatment than the investigators current web-based program. In addition, data indicated that integrating Veteran peers into mental health programs leads to better engagement and greater retention providing the rationale for including Veteran peers rather than therapists (e.g., psychologists, social workers). Given the absence of findings that a brief, peer-supported version of webSTAIR provides improvement in the above symptoms, the research team followed recommendations for the development and testing of psychotherapies and used a waitlist control as an initial test of efficacy.

The aim is to establish the efficacy of BPS webSTAIR in improving symptoms of PTSD and depression, emotion regulation problems and work and social adjustment compared to a Waitlist Control.

Hypothesis 1a: Compared to WL, BPS webSTAIR will provide greater improvement in PTSD symptoms as measured by the PCL5 and depression as measured by the PHQ-8 (secondary outcome). Assessments will be made at pre-treatment, post-treatment, and 8-week follow-up for webSTAIR participants and pre and post-treatment (or 10 weeks from randomization) for WL.

Hypothesis 1b: Compared to WL, BPS webSTAIR will provide greater improvement in emotion regulation as measured by the DERS-16 and overall functioning as measured by the work and social adjustment scale (WSAS) (secondary outcomes). Assessments will be made at pre-treatment, post-treatment and 8-week follow-up for webSTAIR participants and pre and post-treatment (or 10 weeks after randomization) for WL.

In the BPS webSTAIR condition, participants will first complete a welcome module to orient them to the program. After randomization, participants will have 10 weeks to complete the 6 modules. Every time the Veteran logs on they will have the opportunity to engage with a Veteran peer for support through the web program. Contacts can last for up to an hour. Veterans will receive a series of automated reminders and engagement emails that the Vets Prevail program sends at various points in the program.

The equivalence of the treatment conditions on baseline variables demographics and psychological variables) will be assessed and controlled (if necessary) in the final analyses. Other preliminary analyses will include examination of distributional properties of the measures. Transformations will be used to improve distributions when necessary. Missing data patterns (from missed assessments and from dropout) will be examined and compared between conditions. Mixed Effects Models (MEMs) will be used to evaluate differences between the two treatments over time with time as a main effect and treatment-by-time as an interaction term.

Eligibility criteria: Inclusion Criteria:

* Able to read/write English
* Internet connection allowing stable access to VetsPrevail website
* Have experienced at least one traumatic event (positive on the LEC)
* A score greater than or equal to 3 on the PC-PTSD OR greater than or equal to 2 on the PHQ2 on the screen.
* Enrollment into the webSTAIR study must be completed within two weeks of completing screener/eligibility based on symptoms.

Exclusion Criteria:

* Currently receiving a trauma-focused intervention (PE, CPT, EMDR, WET) assessed during baseline
* Being unlikely to benefit from therapy or Telemental health, for example:
* Cognitive difficulties as indicated during baseline assessment.
* Active psychosis as indicated during baseline assessment

Primary outcomes:
measure: Change from Baseline on PTSD Checklist for DSM-5 (PCL-5) at program completion and at two months after program completion.
timeFrame: Before the participant is randomized. 10 weeks from randomization. 2 months after the participant finishes all 6 levels of the intervention for participants engaged in treatment.
measure: Change from Baseline on Personal Health Questionnaire Depression Scale (PHQ - 8) at program completion and at two months after program completion.
timeFrame: Before the participant is randomized. 10 weeks from randomization. 2 months after the participant finishes all 6 levels of the intervention for participants engaged in treatment.
measure: Change from Baseline on Difficulties in Emotion Regulation Scale - 16 item version (DERS-16) at program completion and at two months after program completion.
timeFrame: Before the participant is randomized. 10 weeks from randomization. 2 months after the participant finishes all 6 levels of the intervention for participants engaged in treatment.
measure: Change from Baseline on The Work and Social Adjustment Scale (WSAS) at program completion and at two months after program completion.
timeFrame: Before the participant is randomized. 10 weeks from randomization. 2 months after the participant finishes all 6 levels of the intervention for participants engaged in treatment.
measure: Life Events Checklist for DSM-5 (LEC-2)
timeFrame: Before the participant is randomized to a condition.
Secondary outcomes:
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: VA Palo Alto Health Care System, NC-PTSD, Dissemination and Training Division
state: California
Study officials:
affiliation: National Center for PTSD Dissemination and Training Division
name: Marylene Cloitre, PhD
role: PRINCIPAL_INVESTIGATOR
References: