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.
What safety data exists for web-based therapy for PTSD, including webSTAIR and STAIR?The available research does not directly address the safety data for web-based therapy for PTSD, including webSTAIR and STAIR. However, studies have evaluated the efficacy and benefits of STAIR in various formats, such as group treatment and phase-based therapy, indicating it is an evidence-based treatment. The safety of web-based versions specifically has not been detailed in the provided studies.356711
Do I need to stop my current medications for this trial?The trial protocol does not specify whether you need to stop taking your current medications.
Is the webSTAIR treatment a promising treatment for PTSD?Yes, webSTAIR is a promising treatment for PTSD. It helps improve emotion management and interpersonal skills, which are important for people with PTSD. Studies show that it leads to significant improvements in PTSD symptoms, social functioning, and emotion regulation. It is especially helpful for people in rural areas who might feel isolated.138910
What data supports the idea that Web-Based Therapy for PTSD is an effective treatment?The available research shows that Web-Based Therapy for PTSD, specifically the STAIR program, is effective. In one study, women with PTSD related to childhood abuse who received STAIR showed significant improvements in managing emotions, interpersonal skills, and PTSD symptoms compared to those who did not receive the treatment. These improvements were maintained for several months after the treatment ended. Another study found that women veterans who experienced military sexual trauma and received STAIR via video calls reported high satisfaction and significant improvements in social functioning, PTSD symptoms, depression, and emotion regulation. This suggests that Web-Based Therapy for PTSD can be a successful treatment option, especially for those in rural areas with limited access to in-person therapy.12348
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
I am over 18 years old.
Exclusion Criteria
I do not want to participate in the study.
Treatment Details
The 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.
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.
webSTAIR is already approved in United States for the following indications:
🇺🇸 Approved in United States as webSTAIR for:
- Posttraumatic stress disorder (PTSD)
- Depression
Find a clinic near you
Research locations nearbySelect from list below to view details:
Boston Medical CenterBoston, MA
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Who is running the clinical trial?
Boston Medical CenterLead Sponsor
References
Skills training in affective and interpersonal regulation followed by exposure: a phase-based treatment for PTSD related to childhood abuse. [2022]Fifty-eight women with posttraumatic stress disorder (PTSD) related to childhood abuse were randomly assigned to a 2-phase cognitive-behavioral treatment or a minimal attention wait list. Phase 1 of treatment included 8 weekly sessions of skills training in affect and interpersonal regulation; Phase 2 included 8 sessions of modified prolonged exposure. Compared with those on wait list, participants in active treatment showed significant improvement in affect regulation problems, interpersonal skills deficits, and PTSD symptoms. Gains were maintained at 3- and 9-month follow-up. Phase 1 therapeutic alliance and negative mood regulation skills predicted Phase 2 exposure success in reducing PTSD, suggesting the value of establishing a strong therapeutic relationship and emotion regulation skills before exposure work among chronic PTSD populations.
Trauma healing via cognitive behavior therapy in chronically hospitalized patients. [2021]This study examines the effect of Skill Training In Affect Regulation (STAIR) on a cohort of 24 inpatients with Schizophrenia with histories of significant trauma and Complex PTSD.
Treatment for PTSD related to childhood abuse: a randomized controlled trial. [2022]Posttraumatic stress disorder (PTSD) related to childhood abuse is associated with features of affect regulation and interpersonal disturbances that substantially contribute to impairment. Existing treatments do not address these problems or the difficulties they may pose in the exploration of trauma memories, an efficacious and frequently recommended approach to resolving PTSD. The authors evaluated the benefits and risks of a treatment combining an initial preparatory phase of skills training in affect and interpersonal regulation (STAIR) followed by exposure by comparing it against two control conditions: Supportive Counseling followed by Exposure (Support/Exposure) and skills training followed by Supportive Counseling (STAIR/Support).
A randomized clinical trial comparing affect regulation and social problem-solving psychotherapies for mothers with victimization-related PTSD. [2011]Addressing affect dysregulation may provide a complementary alternative or adjunctive approach to the empirically supported trauma memory processing models of cognitive behavior therapy (CBT) for posttraumatic stress disorder (PTSD). A CBT designed to enhance affect regulation without trauma memory processing--trauma affect regulation: guide for education and therapy (TARGET)--was compared to present centered therapy (PCT) and wait-list (WL) conditions in a randomized clinical trial with 146 primarily low-income and ethnoracial minority mothers with PTSD. TARGET achieved statistically and clinically significant improvement on PTSD and affect regulation measures compared to WL, with more consistent and sustained (over a 6-month follow-up period) evidence of improvement than PCT. Drop-out rates (~25%) were comparable in TARGET and PCT, similar to those previously reported for trauma memory processing CBTs. Symptom worsening was rare (2-8%) and transient. Affect regulation-based CBT without trauma memory processing warrants further research as a potentially efficacious therapy for victimization-related PTSD.
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]Improved accessibility of effective and efficient evidence-based treatments (EBTs) for military personnel suffering with posttraumatic stress disorder (PTSD) is an urgent need to meet the growing demand for timely care. In addition, a better understanding of the mechanism of action of behavioral therapy can inform the delivery of care to meet accessibility demands. Effective EBTs for PTSD are available, but logistical and stigma-related barriers to accessing behavioral healthcare can deter military personnel from receiving these treatments. Web-based treatments represent an innovative way to overcome these barriers. The efficacy of previously developed web-based treatments for PTSD appears promising; however, they were not developed based on treatment protocols with strong empirical support for their efficacy. No study to date has examined web-based treatment of PTSD using a well-established evidence-based treatment, nor delineated the biological mechanisms through which a web-based treatment exerts its effects. This paper describes the rationale and methods of a randomized controlled trial comparing the efficacy and potential biological mediators of 10 sessions of a web-version of Prolonged Exposure (PE), "Web-PE," delivered over 8weeks compared to 10 sessions of in-person Present-Centered Therapy (PCT) delivered over 8weeks by a therapist in 120 active duty military personnel and veterans with PTSD.
Evaluating web-based cognitive-affective remediation in recent trauma survivors: study rationale and protocol. [2020]Background: The immediate aftermath of traumatic events is a period of enhanced neural plasticity, following which some survivors remain with post-traumatic stress disorder (PTSD) whereas others recover. Evidence points to impairments in emotional reactivity, emotion regulation, and broader executive functions as critically contributing to PTSD. Emerging evidence further suggests that the neural mechanisms underlying these functions remain plastic in adulthood and that targeted retraining of these systems may enhance their efficiency and could reduce the likelihood of developing PTSD. Administering targeted neurocognitive training shortly after trauma exposure is a daunting challenge. This work describes a study design addressing that challenge. The study evaluated the direct effects of cognitive remediation training on neurocognitive mechanisms that hypothetically underlay PTSD, and the indirect effect of this intervention on emerging PTSD symptoms. Method: We describe a study rationale, design, and methodological choices involving: (a) participants' enrolment; (b) implementation and management of a daily self-administered, web-based intervention; (c) reliable, timely screening and assessment of treatment of eligible survivors; and (d) defining control conditions and outcome measures. We outline the rationale of choices made regarding study sample, timing of intervention, measurements, monitoring participants' adherence, and ways to harmonize and retain interviewers' fidelity and mitigate eventual burnout by repeated contacts with recently traumatized survivors. Conclusion: Early web-based interventions targeting causative mechanisms of PTSD can be informed by the model presented in this paper.
STAIR Group Treatment for Veterans with PTSD: Efficacy and Impact of Gender on Outcome. [2019]Group Skills Training in Affective and Interpersonal Regulation (STAIR) is an evidence-based, manualized treatment for individuals with post-traumatic stress symptoms, that focuses on improving functioning through mood management (e.g., emotion regulation) and relationship skills development. To date, no study has evaluated the potential benefit of group STAIR among Veterans. Feasibility of delivering STAIR in a mixed-gender group format and the potential impact of gender on outcome were examined.
Telemental Health Delivery of Skills Training in Affective and Interpersonal Regulation (STAIR) for Rural Women Veterans Who Have Experienced Military Sexual Trauma. [2019]This pilot study assessed the feasibility, acceptability, and initial efficacy of a skills-focused treatment delivered via video teleconferencing (VTC) to women veterans living in rural areas who had experienced military sexual trauma (MST). The Skills Training in Affective and Interpersonal Regulation (STAIR) program focuses on teaching emotion management and interpersonal skills in 8 to 10 sessions. The STAIR program may be a good fit for individuals in rural areas for whom social isolation and low social support are particularly problematic. Clinic-to-clinic VTC was used to connect a STAIR therapist with veterans for weekly individual therapy sessions. The participants (n = 10) reported high satisfaction with the intervention and would recommend the program to others. There were significant pretreatment to posttreatment improvements in social functioning, Hedge's g = 1.41, as well as in posttraumatic stress disorder symptoms, Hedge's g = 2.35; depression, Hedge's g = 1.81; and emotion regulation, Hedge's g = 2.32. This is the first report of the successful application of a skills-focused treatment via VTC for women veterans.
Evaluation of an internet-based intervention for service members of the German armed forces with deployment-related posttraumatic stress symptoms. [2020]The present study was designed to evaluate the efficacy of a therapist-guided internet-based cognitive-behavioral therapy (iCBT) intervention for service members of the German Armed Forces with posttraumatic stress disorder (PTSD). The iCBT was adapted from Interapy, a trauma-focused evidence-based treatment based on prolonged exposure and cognitive restructuring. It lasted for 5 weeks and included 10 writing assignments (twice a week). The program included a reminder function if assignments were overdue, but no multimedia elements. Therapeutic written feedback was provided asynchronously within one working day.
Treating posttraumatic stress disorder at home in a single week using 1-week virtual massed cognitive processing therapy. [2022]Posttraumatic stress disorder (PTSD) treatments are increasingly delivered in massed formats and have shown comparable results to standard, weekly treatment. To date, massed cognitive processing therapy (CPT), delivered daily, has been delivered primarily in combination with adjunctive services and among veteran populations, but it has not been rigorously evaluated as a standalone intervention. The present study evaluated 1-week massed CPT delivered virtually (i.e., via telehealth) to a community sample of trauma-exposed individuals (N = 24). Using a single-arm open-label design, participants received CPT twice per day for 5 days. The results indicated that most participants completed treatment (n = 23, 95.8%), and no adverse events were reported. Participants exhibited large reductions in clinician-rated, d = 2.01, and self-reported PTSD symptoms, d = 2.55, as well as self-reported depressive symptoms, d = 1.46. On average, participants reported a 5-point PTSD symptom reduction and 1-point reduction in depressive symptoms for each treatment day. Reductions in PTSD and depressive symptoms were maintained at 3-month follow-up. Overall, 1-week massed CPT delivered virtually was shown to be feasible and to result in rapid symptom reductions that were sustained over time. Virtual massed CPT has the potential to increase access to effective treatments and help trauma survivors restore aspects of their lives in short amounts of time.
Comparing phase-based treatment, prolonged exposure, and skills-training for Complex Posttraumatic Stress Disorder: A randomized controlled trial. [2023]This study examines treatment effects in STAIR Narrative Therapy (SNT), a phase-based treatment where Skills Training in Affective and Interpersonal Regulation (STAIR) precedes Narrative Therapy (NT), compared to Prolonged Exposure (PE) and to STAIR.