Brief Peer Supported webSTAIR Compared to Enhanced Wait ListLast updated on July 2021
- Recruitment Status
- Estimated Enrollment
- Same as current
- Emotion Regulation
- Post Traumatic Stress Disorder
- Not Applicable
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment
- Between 21 years and 80 years
- Both males and females
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-modulen web-based transdiagnostic program that provides skills training in emot...
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-modulen 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 (Ortigo & Cloitre, 2018) 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 (Koenig et al., 2016), 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 (primary outcome) 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. It is anticipated by the researchers that Veterans and other individuals with symptoms of PTSD and depression could potentially benefit in several ways by participating in this study. These benefits may include reduced symptoms of depression and PTSD and improved emotion regulation and work and social adjustment. This is a two-condition randomized controlled trial comparing BPS webSTAIR to WL. Participants will be enrolled in a 2:1 ratio (BPS webSTAIR vs. WL). Participants will be recruited from among users of the Vets Prevail website. A special effort will be made to enroll women Veterans via relevant ads on Facebook and other social media. Vets Prevail is responsible for enrolling 300 Veterans (200 into webSTAIR, 100 into WL). As noted in the study contract, enrollment is defined as the number of participants who have been accepted into the study and randomized into a treatment condition. Vets Prevail is responsible for recruiting and screening veterans and alerting NCPTSD RA to make phone contact with Veteran at all relevant assessment periods (baseline, post-tx and follow-up). The NCPTSD RA will facilitate completion of verbal informed consent, describe program including goal of completing program in 10 weeks answer questions about the study and motivate engagement in the program. The NCPTSD RA will then read through the baseline questions and document the answers. The RA will also inquire about veteran's interest in doing an extra phone interview (CAPS-5) and complete it on the phone during the same call if they are interested. At the end of the call, the RA will recommend to the Veteran that they enter the Welcome Module and provide guidance to them at that time if they are ready to begin program. In regards to the interview, every quarter, every other participant will be provided with an option to participate in the CAPS-5 until 8 individuals have agreed to the assessment that quarter. The total number of CAPS-5 collected is expected to be 32 or approximately 10% of study participants. Individuals accepted into the study will either be provided with access to BPS webSTAIR or placed on waitlist. Participants in BPS webSTAIR will complete a posttreatment assessment and 2-month follow-up. Participants in the WL condition will complete a second assessment at 10th week, conclude their involvement in the study and be offered the Vets Prevail coping program. 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. Participants will be random.
- NCT #
- Not Provided
- Not Provided