~47 spots leftby Dec 2025

Web-Based Therapy for PTSD

(webSTAIR Trial)

SV
Overseen bySarah Valentine, PhD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Boston Medical Center
Disqualifiers: Declines participation
No Placebo Group
Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

Posttraumatic stress disorder (PTSD) is a significant public health challenge with population prevalence rates in the US between 6.1 to 9.2%. There are large racial and socioeconomic inequities in access to PTSD treatment, as up to half (30-50%) of patients in safety net clinical settings meet criteria for PTSD, yet only 13% receive any behavioral health treatment. Workforce shortages are one major barrier to accessing care. Additional barriers to care can include heightened mental health stigma and mistrust of health services. Digital mental health interventions (DMHIs) may be suitable within the continuum of care for PTSD in hospital settings, given their potential for rapid-access, scalability, and the high acceptability of DMHI among individuals with high stigma and social needs. Among the available DMHIs for PTSD, the investigators have selected web-administered Skills Training in Affective and Interpersonal Regulation (webSTAIR), based on emerging scientific evidence and a close collaboration with Boston Medical Center (BMC) users (patients and providers) in a previous pilot study in primary care. The aim of this randomized study is to implement webSTAIR at BMC in the Recovery from Stress and Trauma through Outpatient Care, Research, and Education (RESTORE) Center's subspecialty clinic.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment webSTAIR for PTSD?

Research shows that the STAIR program, which is part of webSTAIR, helps improve emotion management and interpersonal skills, leading to significant reductions in PTSD symptoms. Studies have found that participants in STAIR-based treatments report high satisfaction and improvements in social functioning, PTSD symptoms, depression, and emotion regulation.12345

Is web-based therapy for PTSD, like webSTAIR or STAIR, safe for humans?

The studies reviewed do not specifically address the safety of web-based therapy for PTSD, but STAIR, a related treatment, is described as an evidence-based approach focusing on mood management and relationship skills, suggesting it is generally considered safe for use in humans.16789

How is the webSTAIR treatment for PTSD different from other treatments?

The webSTAIR treatment is unique because it combines skills training in managing emotions and improving interpersonal relationships with exposure therapy, addressing both emotional regulation and trauma processing, which are often not covered together in other PTSD treatments.1231011

Research Team

SV

Sarah Valentine, PhD

Principal Investigator

Boston Medical Center, Psychiatry Department

Eligibility Criteria

This trial is for adults over 18 who've experienced trauma, likely have PTSD (with a PCL score of 33+), and are on the RESTORE Center waitlist at Boston Medical Center. They must be able to engage in therapy in English or Spanish and have reasonable access to technology like phones or computers.

Inclusion Criteria

Probable PTSD (as indicated by the PTSD Checklist for the DSM-5 [PCL-5] based on PCL score of 33+)
Client on the RESTORE Center waitlist at Boston Medical Center
Reasonable access to technology (e.g., phone, computer, internet access)
See 3 more

Exclusion Criteria

I do not want to participate in the study.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive web-administered Skills Training in Affective and Interpersonal Regulation (webSTAIR), either self-directed or with coaching from a Community Health Worker

3 months
Web-based sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

Treatment Details

Interventions

  • webSTAIR (Behavioural Intervention)
Trial OverviewThe study tests webSTAIR, an online program designed to help with emotional and interpersonal skills after trauma, combined with CHW coaching. It's aimed at patients facing barriers to care such as stigma or mistrust of health services.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Self-directed webSTAIRExperimental Treatment1 Intervention
Participants on the Research, and Education Center (RESTORE) waitlist randomized to this arm will receive the self-managed web-administered Skills Training in Affective and Interpersonal Regulation (webSTAIR).
Group II: webSTAIR with coaching from a Community Health Worker (CHW)Active Control2 Interventions
Participants on the RESTORE waitlist randomized to this arm will receive the web-administered Skills Training in Affective and Interpersonal Regulation (webSTAIR) with coaching support from a CHW.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Boston Medical Center

Lead Sponsor

Trials
410
Recruited
890,000+
Dr. Alastair Bell profile image

Dr. Alastair Bell

Boston Medical Center

Chief Executive Officer since 2023

MD from University of Oxford, MBA from Harvard Business School

Dr. Ravin Davidoff profile image

Dr. Ravin Davidoff

Boston Medical Center

Chief Medical Officer since 2008

M.B., B.Ch. from University of Witwatersrand, South Africa

Findings from Research

In a study of 104 women with PTSD related to childhood abuse, a treatment combining skills training in affect regulation followed by exposure therapy (STAIR/Exposure) led to a higher rate of sustained PTSD remission (27%) compared to supportive counseling followed by exposure (13%) and skills training followed by supportive counseling (0%).
The STAIR/Exposure group also showed greater improvements in emotion regulation and interpersonal problems, had a lower dropout rate, and experienced fewer worsening PTSD symptoms during treatment compared to the other two conditions.
Treatment for PTSD related to childhood abuse: a randomized controlled trial.Cloitre, M., Stovall-McClough, KC., Nooner, K., et al.[2022]
A study involving 58 women with PTSD from childhood abuse showed that a two-phase cognitive-behavioral treatment significantly improved their emotional regulation, interpersonal skills, and PTSD symptoms compared to a waitlist group.
The success of the treatment was linked to the strength of the therapeutic alliance and the development of negative mood regulation skills during the initial phase, highlighting the importance of these factors before engaging in exposure therapy.
Skills training in affective and interpersonal regulation followed by exposure: a phase-based treatment for PTSD related to childhood abuse.Cloitre, M., Koenen, KC., Cohen, LR., et al.[2022]
In a study involving 92 adults with PTSD and CPTSD, Prolonged Exposure (PE) therapy was found to be more effective than STAIR Narrative Therapy (SNT) in reducing PTSD symptoms from pre-treatment to post-treatment.
While STAIR showed similar effectiveness to PE in improving CPTSD symptoms, the anticipated advantages of SNT over PE and STAIR were not supported, suggesting that immediate trauma-focused treatments may be more beneficial than phase-based approaches.
Comparing phase-based treatment, prolonged exposure, and skills-training for Complex Posttraumatic Stress Disorder: A randomized controlled trial.Sele, P., Hoffart, A., Cloitre, M., et al.[2023]

References

Treatment for PTSD related to childhood abuse: a randomized controlled trial. [2022]
Skills training in affective and interpersonal regulation followed by exposure: a phase-based treatment for PTSD related to childhood abuse. [2022]
Telemental Health Delivery of Skills Training in Affective and Interpersonal Regulation (STAIR) for Rural Women Veterans Who Have Experienced Military Sexual Trauma. [2019]
Trauma healing via cognitive behavior therapy in chronically hospitalized patients. [2021]
A randomized clinical trial comparing affect regulation and social problem-solving psychotherapies for mothers with victimization-related PTSD. [2011]
Comparing phase-based treatment, prolonged exposure, and skills-training for Complex Posttraumatic Stress Disorder: A randomized controlled trial. [2023]
Design of a randomized controlled trial examining the efficacy and biological mechanisms of web-prolonged exposure and present-centered therapy for PTSD among active-duty military personnel and veterans. [2019]
Evaluating web-based cognitive-affective remediation in recent trauma survivors: study rationale and protocol. [2020]
STAIR Group Treatment for Veterans with PTSD: Efficacy and Impact of Gender on Outcome. [2019]
Evaluation of an internet-based intervention for service members of the German armed forces with deployment-related posttraumatic stress symptoms. [2020]
11.United Statespubmed.ncbi.nlm.nih.gov
Treating posttraumatic stress disorder at home in a single week using 1-week virtual massed cognitive processing therapy. [2022]