Web-Based Therapy for PTSD

(webSTAIR Trial)

Overseen By Sarah Valentine, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Boston Medical Center

Disqualifiers: Declines participation

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 3 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a web-based therapy for individuals with posttraumatic stress disorder (PTSD). The goal is to make treatment more accessible, particularly for those facing barriers like stigma or limited access to traditional therapy. Participants will either use a self-directed online program called webSTAIR (Skills Training in Affective and Interpersonal Regulation) or receive additional support from a community health worker. Individuals who have experienced trauma and are currently on the Boston Medical Center's waitlist for therapy might be suitable candidates, especially if they have reliable internet access. As an unphased trial, this study offers a unique opportunity to access innovative therapy methods that could enhance mental health.

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 prior data suggests that webSTAIR is safe for PTSD treatment?

Research has shown that webSTAIR, a digital therapy for PTSD, is generally easy to use. In earlier studies, participants using webSTAIR experienced improvements in PTSD and depression symptoms. They also became better at managing emotions and interacting with others. These results suggest that the treatment is safe for users.

Another study examined the safety and effectiveness of similar therapy programs and found significant symptom reductions in participants, further supporting the safety of webSTAIR.

Although this trial lacks a specific phase, existing evidence from past studies indicates that webSTAIR is a safe option for treating PTSD symptoms. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about webSTAIR for PTSD because it offers a fresh approach to therapy by being entirely web-based, which could make it more accessible for people who can't easily get to traditional therapy sessions. Unlike standard treatments like cognitive-behavioral therapy (CBT) or medication, webSTAIR allows participants to work through skills training on their own or with guidance from a Community Health Worker (CHW), adding flexibility and support. This method focuses on improving emotional regulation and interpersonal skills, which are crucial for managing PTSD symptoms. The combination of accessibility, self-direction, and optional coaching sets webSTAIR apart as a potentially game-changing option for those with PTSD.

What evidence suggests that webSTAIR could be an effective treatment for PTSD?

Research has shown that the webSTAIR program can effectively reduce PTSD symptoms. One study demonstrated moderate-to-large improvements in symptoms of PTSD and depression through webSTAIR. Participants also found it easier to manage their emotions and improve social interactions. In this trial, participants will be randomized to receive either self-directed webSTAIR or webSTAIR with coaching from a Community Health Worker (CHW). These findings suggest that webSTAIR might be a promising option for those dealing with PTSD, potentially helping people better manage their feelings and enhance their everyday lives. ^{1 2 4 6 7}

Who Is on the Research Team?

Sarah Valentine, PhD

Principal Investigator

Boston Medical Center, Psychiatry Department

Are You a Good Fit for This Trial?

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+)

Reasonable access to technology (e.g., phone, computer, internet access)

Client on the RESTORE Center waitlist at Boston Medical Center

Exclusion Criteria

I do not want to participate in the study.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• webSTAIR

Trial Overview

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.

How Is the Trial Designed?

Group I: Self-directed webSTAIR Experimental Treatment 1 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 Control 2 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

Who Is Running the Clinical Trial?

Boston Medical Center

Lead Sponsor

Trials

410

Recruited

890,000+

Published Research Related to This Trial

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment for PTSD related to childhood abuse: a randomized controlled trial. Cloitre, M., Stovall-McClough, KC., Nooner, K., et al.[2022]

The study evaluated a 5-week therapist-guided internet-based cognitive-behavioral therapy (iCBT) for 37 service members with PTSD, but found that improvements in PTSD symptoms were small and not statistically significant.

While there were small significant improvements in anxiety levels from pre-treatment to follow-up, the high dropout rate of 32.3% highlights challenges in treatment engagement among military personnel.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of an internet-based intervention for service members of the German armed forces with deployment-related posttraumatic stress symptoms. Niemeyer, H., Knaevelsrud, C., Schumacher, S., et al.[2020]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

A 1-week virtual massed cognitive processing therapy (CPT) program for PTSD was successfully completed by 95.8% of participants, with no reported adverse events, indicating its safety and feasibility.

Participants experienced significant reductions in PTSD symptoms (d = 2.01) and depressive symptoms (d = 1.46), with improvements maintained at a 3-month follow-up, suggesting that this intensive treatment can effectively alleviate trauma-related symptoms in a short time frame.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treating posttraumatic stress disorder at home in a single week using 1-week virtual massed cognitive processing therapy. Held, P., Kovacevic, M., Petrey, K., et al.[2022]

Group Skills Training in Affective and Interpersonal Regulation (STAIR) significantly improved PTSD symptoms and general psychological distress in a study of 39 Veterans, with effect sizes indicating strong benefits (Cohen's d = 0.91 for PTSD and d = 0.90 for psychological distress).

While both male and female Veterans showed improvements in PTSD symptoms, only male Veterans experienced a significant reduction in general psychological distress, highlighting the need to explore gender differences in responses to mixed-gender group therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

STAIR Group Treatment for Veterans with PTSD: Efficacy and Impact of Gender on Outcome. Jackson, C., Weiss, BJ., Cloitre, M.[2019]

The study involved 24 inpatients with schizophrenia and complex PTSD who participated in 12 weeks of group-based Cognitive Behavior Therapy focused on trauma healing, which led to significant improvements in emotional regulation and control over anger and hostility.

Patients receiving the Skill Training In Affect Regulation (STAIR) therapy showed better outcomes compared to those receiving supportive psychotherapy, indicating that targeted trauma recovery approaches can be beneficial for individuals with chronic mental illness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trauma healing via cognitive behavior therapy in chronically hospitalized patients. Trappler, B., Newville, H.[2021]

The trauma affect regulation therapy (TARGET) significantly improved PTSD symptoms and affect regulation in 146 low-income and ethnoracial minority mothers compared to a wait-list group, showing sustained benefits over a 6-month follow-up.

TARGET was more effective than present centered therapy (PCT) in maintaining improvements, with low rates of symptom worsening, suggesting that affect regulation-focused CBT could be a valuable alternative for treating PTSD without directly processing trauma memories.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized clinical trial comparing affect regulation and social problem-solving psychotherapies for mothers with victimization-related PTSD. Ford, JD., Steinberg, KL., Zhang, W.[2011]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

The pilot study demonstrated that the STAIR program, delivered via video teleconferencing, is feasible and well-accepted by women veterans in rural areas who have experienced military sexual trauma, with high participant satisfaction reported.

Participants showed significant improvements in various areas, including social functioning and symptoms of PTSD, depression, and emotion regulation, indicating the initial efficacy of the STAIR program with effect sizes ranging from Hedge's g = 1.41 to 2.35.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telemental Health Delivery of Skills Training in Affective and Interpersonal Regulation (STAIR) for Rural Women Veterans Who Have Experienced Military Sexual Trauma. Weiss, BJ., Azevedo, K., Webb, K., et al.[2019]

A randomized controlled trial is being conducted to compare the efficacy of a web-based version of Prolonged Exposure therapy (Web-PE) with in-person Present-Centered Therapy (PCT) for treating PTSD in 120 active duty military personnel and veterans over 8 weeks.

This study aims to not only assess the effectiveness of Web-PE but also to explore the biological mechanisms that may underlie its therapeutic effects, addressing the urgent need for accessible PTSD treatments in the military.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. McLean, CP., Rauch, SAM., Foa, EB., et al.[2019]

The study outlines a design for a web-based cognitive remediation training aimed at enhancing neurocognitive functions that may help prevent the development of PTSD in trauma survivors.

By focusing on early intervention shortly after trauma exposure, the study aims to address the challenges of administering targeted training to improve emotional reactivity and regulation, potentially reducing PTSD symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating web-based cognitive-affective remediation in recent trauma survivors: study rationale and protocol. Fine, NB., Achituv, M., Etkin, A., et al.[2020]

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