NCT06947538 · Boston Medical Center
Stepped Care for Posttraumatic Stress Disorder Study
(STEPPS)
What this study is about
Less than 20% of people with PTSD receive any treatment. This study extends a program of research by the investigator focused on developing adaptive (stepped) interventions for PTSD. The adaptive intervention sequences a digital mental health intervention (DMHI) and brief trauma- and skills-focused treatments for PTSD.
View original scientific description
Less than 20% of people with PTSD receive any treatment. This study extends a program of research by the investigator focused on developing adaptive (stepped) interventions for PTSD. The adaptive intervention sequences a digital mental health intervention (DMHI) and brief trauma- and skills-focused treatments for PTSD. The selected treatments are brief and scalable and less burdensome to systems of care. These treatments are: web-administered Skills Training in Affective and Interpersonal Regulation (webSTAIR), Brief STAIR, and Written Exposure Therapy (WET).
Interventions
BEHAVIORAL
webSTAIR
WebSTAIR consists of 10 online modules that provide psychoeducation on trauma and emotions and teach skills to improve coping with emotions and strengthen interpersonal relationships. Modules are completed at the participants' own pace and utilize interactive exercises, and audio and video components to aid in delivery.
BEHAVIORAL
WebSTAIR plus coaching
WebSTAIR with up to five 30-min coaching sessions with a CHW will focus on guiding participants through the program, discussing exercises that are valuable or problematic, and reviewing module content.
BEHAVIORAL
Clinician administered Brief STAIR
Brief STAIR is a brief, low intensity, therapy that utilizes psychoeducation, coping skills training, and does not include recounting of the trauma memory, making it highly tolerable. It will be delivered by mental health clinicians in five to six 30-minute individual sessions.
BEHAVIORAL
Clinician administered WET
WET is a brief, high intensity, exposure-based treatment delivered by mental health clinicians consisting of six 30-minute individual sessions that cover treatment rationale, psychoeducation about PTSD, and directing participants to write in session about their traumatic experience using scripted instructions.
Primary outcome measures
PTSD symptom severity
Time frame: baseline, 4 weeks, 8 weeks, 18 weeks, 30 weeks
This outcome will be assessed by the PTSD Checklist for the DSM-5 (PCL-5), a 20-item self-report measure that evaluates the degree to which individuals have been bothered by PTSD symptoms in the past month tied to their most distressing event. Total scores ranging from 0 to 80, and a score of 31-33 or higher suggests probable PTSD and potential benefit from treatment.
Treatment retention
Time frame: 4 weeks, 8 weeks, 18 weeks
as the proportion (%) of participant who complete 60% of interventions in the treatment windows.
Treatment acceptability
Time frame: 4 weeks, 8 weeks, 18 weeks, 30 weeks
This outcome will be assessed with the Client Satisfaction Questionnaire 8 \[CSQ-8\], a 8-item instruction where scores are summed across items once. Items 2, 4, 5, and 8 are reverse scored. Total scores range from 8 to 32, with the higher number indicating greater satisfaction.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Assessed at pre-screening
- Boston Medical Center primary care patient
- At least 18 years of age
- Access to computer or mobile device
- Able to receive treatments in English or Spanish
- Able to read at 4th grade level Assessed at baseline
- Endorsement of Criterion A trauma using the Life Events Checklist for the DSM-5 (LEC-5), assessed at baseline
- PTSD diagnosis, confirmed by the Clinician-Administered PTSD Scale for the DSM-5 (CAPS-5) assessed at baseline
- Clinically appropriate for outpatient level of care
- Stable on psychotropic medication for \>4 weeks
Exclusion criteria
- Assessed at pre-screening • Patient is currently engaged in clinician-administered therapy Assessed at baseline (clinician interview)
- Patient is not clinically appropriate for outpatient level of care.
- Acute risk for suicidal thoughts or behaviors, assessed by the Columbia Suicide Severity Rating Scale, administered by research clinician at baseline.
Where
- Boston, Massachusetts
Collaborators
National Institute of Mental Health (NIMH)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 14, 2026 · Source of record for eligibility and locations