Brief Peer Supported webSTAIR Compared to Enhanced Wait List

NCT04286165 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 178

Last updated 2023-08-18

No results posted yet for this study

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

Interventions

OTHER

Brief Peer Supported webSTAIR

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).

Sponsors & Collaborators

  • Palo Alto Veterans Institute for Research

    lead OTHER

Principal Investigators

  • Marylene Cloitre, PhD · National Center for PTSD Dissemination and Training Division

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-20
Primary Completion
2022-06-01
Completion
2022-09-28

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04286165 on ClinicalTrials.gov