Brief Peer Supported webSTAIR Compared to Enhanced Wait List

NCT04286165 | Completed

• 1 other identifier: CLO0009
• Study Type: interventional
• Target: 178
• Locations: 1 country
• Sites: 1

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.

Conditions

Post Traumatic Stress Disorder; Depression; Emotion Regulation

Keywords

PTSD; Post Traumatic Stress Disorder; Depression; Emotion Regulation; Skills Building; Peer; Coaching; Online

Outcome Measures

Primary Outcomes (5)

• Change from Baseline on PTSD Checklist for DSM-5 (PCL-5) at program completion and at two months after program completion.

  The PTSD Checklist for DSM-5 (PCL-5) is a 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD. The PCL-5 has a variety of purposes, including, monitoring symptom change during and after treatment, screening individuals for PTSD and making a provisional PTSD diagnosis. The scale ranges from Not At All (0) to Extremely (4) Higher scores relate to more severe symptoms.

  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.

• Change from Baseline on Personal Health Questionnaire Depression Scale (PHQ - 8) at program completion and at two months after program completion.

  The eight-item Personal Health Questionnaire Depression Scale (PHQ - 8) is established as a valid diagnostic and severity measure for depressive disorders in large clinical studies.The scale ranges from Not At All (1) to Nearly Every Day (4) Higher scores relate to more severe symptoms.

  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.

• Change from Baseline on Difficulties in Emotion Regulation Scale - 16 item version (DERS-16) at program completion and at two months after program completion.

  Difficulties in Emotion Regulation Scale - 16 item version (DERS-16) is a widely-used, theoretically-driven, and psychometrically-sound self-report measure of emotion regulation difficulties. The scale ranges from Almost Never (1) to Almost Always (5). Higher scores relate to more severe symptoms.

  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.

• Change from Baseline on The Work and Social Adjustment Scale (WSAS) at program completion and at two months after program completion.

  The The Work and Social Adjustment Scale (WSAS) is a measure of people's problems sometimes affect their ability to do certain day-to-day tasks in their lives. To rate your problems, look at each section and determine on the scale provided how much your problem impairs your ability to carry out the activity in the past month.The scale ranges from No Impairment (0) to Very Severe Impairment (8). Higher scores relate to more severe impairment.

  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.

• Life Events Checklist for DSM-5 (LEC-2)

  The Life Events Checklist for DSM-5 (LEC-2) lists difficult or stressful things that sometimes happen to people. Mark the item for any single stressful event you have experienced. Be sure to consider your entire life (growing up, as well as adulthood) as you go through the list of events. You do not need to answer any of these questions if doing so would be distressing. The scale consists of Yes, No and Prefer Not To Answer. More Yes responses indicate experiencing more traumatic events in a participant's history.

  Before the participant is randomized to a condition.

Study Arms (2)

BPS webSTAIR 6 Levels with Peer Support

ACTIVE COMPARATOR

Participants in BPS webSTAIR will complete a baseline, posttreatment and 2-month follow-up assessment. 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.

Other: Brief Peer Supported webSTAIR

Wait List

NO INTERVENTION

In Wait list, participants will be asked to go about their life as usual. They will be asked not to participate in any other programs for PTSD or depression symptoms for 10 weeks. After the 10 weeks, WL participants can begin any other program for PTSD or depression. They will also be given the option of participating in BPS webSTAIR or be provided with information about other web-based programs that might be of interest or relevant to them.

Interventions

Brief Peer Supported webSTAIR OTHER

The BPS webSTAIR program is an online platform where individuals are taught skills in emotion regulation. In this program they will learn how to recognize the emotions they are feeling by assessing their own body language, being attentive to their thought processes, and attempting to replace negative behaviors with positive. Throughout the platform they will engage in written exercises to help them solidify the lessons with their own life experiencing. They will also have the support of peers throughout the program to help them when they need clarification or having a difficult time applying the lesson(s).

BPS webSTAIR 6 Levels with Peer Support

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Palo Alto Veterans Institute for Research: lead

Study Sites (1)

VA Palo Alto Health Care System, NC-PTSD, Dissemination and Training Division

Palo Alto, California, 94304, United States

Location

Related Publications (1)

• Ong LE, Speicher S, Villasenor D, Kim J, Jacobs A, Macia KS, Cloitre M. Brief Peer-Supported Web-Based Skills Training in Affective and Interpersonal Regulation (BPS webSTAIR) for Trauma-Exposed Veterans in the Community: Randomized Controlled Trial. J Med Internet Res. 2024 Oct 2;26:e52130. doi: 10.2196/52130.

  PMID: 39012722 DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Depression; Emotional Regulation

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Behavioral Symptoms; Behavior; Self-Control; Social Behavior

Study Officials

• Marylene Cloitre, PhD

  National Center for PTSD Dissemination and Training Division

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 8, 2020
• First Posted: February 26, 2020
• Study Start: January 20, 2020
• Primary Completion: June 1, 2022
• Study Completion: September 28, 2022
• Last Updated: August 18, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)