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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 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 3 months, 9 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 3 months, 9 months
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 moreSecondary 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
2,798 Previous Clinical Trials
2,660,858 Total Patients Enrolled
Boston Medical CenterLead Sponsor
388 Previous Clinical Trials
873,940 Total Patients Enrolled
Sarah Valentine, PhDPrincipal InvestigatorBoston Medical Center, Psychiatry Department
1 Previous Clinical Trials
80 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are currently receiving a type of therapy called cognitive behavioral therapy for PTSD somewhere else.You are currently dealing with the loss of someone close to you and need support specifically for grief, rather than treatment for post-traumatic stress disorder (PTSD).You have experienced a traumatic event, as determined by a checklist called LEC-5.
Research Study Groups:
This trial has the following groups:- Group 1: WebSTAIR Group
- Group 2: STAIR-PC Group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Post-Traumatic Stress Disorder Patient Testimony for trial: Trial Name: NCT04937504 — N/A
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