Stepped Care for Posttraumatic Stress Disorder Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: webSTAIR, WebSTAIR plus coaching, Clinician administered Brief STAIR, Clinician administered WET.
- Who it may be relevant to
- Registry conditions: Post Traumatic Stress Disorder. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Adaptive Interventions to Improve Posttraumatic Stress Disorder (PTSD) Treatment Access, Engagement, and Effectiveness in Routine Care
Overview
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).
Detailed description
This study uses a Sequential, Multiple Assignment, Randomized Trial (SMART) design.
At baseline, participants are randomized to Stage 1 Treatments, either webSTAIR (self-managed) or webSTAIR plus community health worker coaching. At 8 weeks, stage 1 nonresponders are re-randomized to Stage 2 clinician-administered treatments, either Brief STAIR or WET.
Nonresponse is defined as less than a 15-point decrease in PTSD symptom severity from baseline, as measured by the PTSD Checklist for DSM-5 (PCL-5).
The objectives of this study are to:
* examine the main effects of stage 1 treatments, stage 2 treatments, and embedded * adaptive interventions on PTSD symptom severity. * confirm mechanisms of change established in the extant PTSD literature * identify patient-level moderators of change in PTSD symptoms severity at 18 weeks
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]
- Treatment retention [Time frame: 4 weeks, 8 weeks, 18 weeks]
- Treatment acceptability [Time frame: 4 weeks, 8 weeks, 18 weeks, 30 weeks]
Secondary outcome measures (6)
- Trauma coping self-efficacy [Time frame: baseline, 4 weeks, 8 weeks, 18 weeks, 30 weeks]
- Treatment expectancy [Time frame: baseline, 4 weeks, 8 weeks, 18 weeks, 30 weeks]
- Mental health stigma [Time frame: baseline, 4 weeks, 8 weeks, 18 weeks, 30 weeks]
- Medical mistrust [Time frame: baseline, 4 weeks, 8 weeks, 18 weeks, 30 weeks]
- Posttraumatic cognitions [Time frame: baseline, 4 weeks, 8 weeks, 18 weeks, 30 weeks]
- Pathological fear extinction [Time frame: baseline, 4 weeks, 8 weeks, 18 weeks, 30 weeks]
Eligibility criteria
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
\- Concordance between CAPS-5 and PCL-5 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Boston Medical Center — Boston
Identifiers
NCT: NCT06947538 · H-45694 · 1R01MH138549-01