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Behavioral Intervention

STAIR Skills Training for PTSD (I-STEP Trial)

N/A
Waitlist Available
Led By Sarah Valentine, PhD
Research Sponsored by Boston Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 3 months, 9 months
Awards & highlights

I-STEP Trial Summary

This trial will test a new intervention for PTSD that will be offered in Boston Medical Center's primary care clinics as the new standard of care.

Who is the study for?
This trial is for individuals who have experienced trauma and are showing signs of PTSD, as confirmed by specific checklists. They must be patients at Boston Medical Center's primary care clinics, speak English, and have access to technology like a phone or computer with internet.Check my eligibility
What is being tested?
The study tests a cognitive-behavioral therapy called STAIR for PTSD in two formats: one led by clinicians (STAIR-PC) and another self-guided online version (WebSTAIR). It aims to make this treatment part of the standard care in primary clinics.See study design
What are the potential side effects?
While not explicitly listed, side effects may include emotional discomfort or distress due to discussing traumatic events during therapy sessions. The intervention is non-medical, so typical drug-related side effects are not expected.

I-STEP Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 3 months, 9 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 3 months, 9 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Acceptability measured by Client Satisfaction Questionnaire (CSQ-8) at 3 months
Acceptability measured by Client Satisfaction Questionnaire (CSQ-8) at 9 months
Feasibility based on retention
+1 more
Secondary outcome measures
Emotional Regulation measured by the Difficulties in Emotion Regulation Scale (DERS)
General Mental Health Functioning measured by the Brief Symptom Inventory (BSI-18)
Social Functioning measured by the Interpersonal Support Evaluation List - 12-item version (ISEL-12)

I-STEP Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: WebSTAIR GroupExperimental Treatment1 Intervention
Participants in the WebSTAIR group will complete 10 self-guided, web-based modules for up to 12 weeks.
Group II: STAIR-PC GroupActive Control1 Intervention
Participants in the Skills Training in Affective and Interpersonal Regulation for Primary Care (STAIR-PC) group will complete five (30 minute each) therapist-led sessions in-person or via Telehealth for up to 12 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
WebSTAIR Group
2021
N/A
~60

Find a Location

Who is running the clinical trial?

National Institute of Mental Health (NIMH)NIH
2,783 Previous Clinical Trials
2,689,067 Total Patients Enrolled
Boston Medical CenterLead Sponsor
383 Previous Clinical Trials
871,089 Total Patients Enrolled
Sarah Valentine, PhDPrincipal InvestigatorBoston Medical Center, Psychiatry Department

Media Library

STAIR-PC Group (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT04937504 — N/A
Post-Traumatic Stress Disorder Research Study Groups: WebSTAIR Group, STAIR-PC Group
Post-Traumatic Stress Disorder Clinical Trial 2023: STAIR-PC Group Highlights & Side Effects. Trial Name: NCT04937504 — N/A
STAIR-PC Group (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04937504 — N/A
Post-Traumatic Stress Disorder Patient Testimony for trial: Trial Name: NCT04937504 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this medical research actively seeking participants?

"According to clinicaltrials.gov, this medical study is currently looking for applicants and was first posted on the twenty-ninth of June 2021 with a recent update taking place on the eighth of July 2022."

Answered by AI

How many individuals have been recruited to participate in this trial?

"Confirmed. The information posted on clinicaltrials.gov attests to the fact that this experiment is currently recruiting participants; it was initially listed on June 29th 2021 and last updated July 8th 2022. This study requires 60 trials from one medical facility."

Answered by AI

Who else is applying?

What state do they live in?
Massachusetts
What site did they apply to?
Boston Medical Center Clinics
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

I’ve tried a medication but it just makes me sleepy.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
Implementing a Skills Training Evidence-Based Treatment for Posttraumatic Stress Disorder in Primary Care
2021. "Implementing a Skills Training Evidence-Based Treatment for Posttraumatic Stress Disorder in Primary Care". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04937504.
~16 spots leftby Apr 2025
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