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De klinische studie NCT06947538 (STEPPS) voor Posttraumatische stressstoornis is nog niet rekruterend. Bekijk de kaartweergave van de Klinische Studies Radar en de AI-ontdekkingstools voor alle details. Of stel hier een vraag. | ||
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Kaartweergave
Stepped Care for Posttraumatic Stress Disorder Study (STEPPS)
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De klinische studie NCT06947538 (STEPPS) is een interventioneel studie bij Posttraumatische stressstoornis met de status nog niet rekruterend. De inclusie van 428 deelnemers start op 1 februari 2026. De studie wordt geleid door Boston Medical Center en de voltooiing is gepland op 1 juni 2029. Laatste update op ClinicalTrials.gov: 7 oktober 2025.
Beknopte samenvatting
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).
Uitgebreide beschrijving
This study uses a Sequential, Multiple Assignment, Randomized Trial (SMART) design. All participants enrolled will receive access to webSTAIR at baseline ("initial treatment").
Nonresponders at 4 weeks are randomized to either continue webSTAIR or webSTAIR plus community health worker coaching ("stage 1 treatments").
Nonresponders at 8 weeks are re-randomized to clinician-administered treatments, either Brief STAIR or WET ("stage 2 treatments").
Nonresponse is defined as less than a 15-point decrease in PTSD symptom severity, 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
Officiële titel
Adaptive Interventions to Improve Posttraumatic Stress Disorder (PTSD) Treatment Access, Engagement, and Effectiveness in Routine Care
Aandoeningen
Posttraumatische stressstoornisAndere studie-ID's
- STEPPS
- H-45694
- 1R01MH138549-01 (Subsidie/contract van NIH (VS))
NCT-ID
Startdatum (Werkelijk)
2026-02
Laatste update geplaatst
2025-10-07
Verwachte einddatum
2029-06
Inschrijving (Geschat)
428
Studietype
Interventioneel
FASE
N.v.t.
Status
Nog niet rekruterend
Trefwoorden
Stepped Care
Skills training in affective and interpersonal regulation (STAIR)
Digital Mental Health Intervention
Written Exposure Therapy (WET)
Adaptive Interventions
Skills training in affective and interpersonal regulation (STAIR)
Digital Mental Health Intervention
Written Exposure Therapy (WET)
Adaptive Interventions
Primaire doel
Behandeling
Toewijzing
Gerandomiseerd
Interventiemodel
Sequentieel
Blindering
Geen (Open-label)
Armen / Interventies
| Deelnemersgroep/Studiearm | Interventie/Behandeling |
|---|---|
Actieve comparatorwebSTAIR, webSTAIR to WET First, offer skills-focused digital mental health intervention (DMHI); then switch to clinician-administered trauma-focused behavioral treatment for nonresponders and continue skills-focused DMHI for responders. | 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. 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. |
Actieve comparatorwebSTAIR+coaching, webSTAIR+coaching to WET First, offer skills-focused DMHI plus community health worker (CHW) coaching; then add clinician-administered trauma-focused behavioral treatment for nonresponders and continue skills-focused DMHI plus CHW coaching for responders. | 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. 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. |
Actieve comparatorwebSTAIR, webSTAIR to Brief STAIR First, offer skills-focused DMHI; then add clinician-administered skills-focused behavioral treatment for nonresponders and continue skills-focused DMHI for responders. | 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. 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. |
Actieve comparatorwebSTAIR+coaching, websTAIR+coaching to Brief STAIR First, offer skills-focused DMHI plus CHW coaching; then add clinician-administered skills-focused behavioral treatment for nonresponders and continue skills-focused DMHI plus CHW coaching for responders. | 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. 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. |
Primaire uitkomst
Secundaire uitkomst
| Uitkomstmaat | Beschrijving van de uitkomstmaat | Tijdsbestek |
|---|---|---|
PTSD symptom severity | 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. | baseline, 4 weeks, 8 weeks, 18 weeks, 30 weeks |
Treatment retention | as the proportion (%) of participant who complete 60% of interventions in the treatment windows. | 4 weeks, 8 weeks, 18 weeks |
Treatment acceptability | 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. | 4 weeks, 8 weeks, 18 weeks, 30 weeks |
| Uitkomstmaat | Beschrijving van de uitkomstmaat | Tijdsbestek |
|---|---|---|
Trauma coping | This outcome will be assessed with the Trauma Coping Self-Efficacy Scale (TCSE, a 9-item instrument with items rated on a 7-point scale (1=not at all capable to 7=totally capable) and a total score calculated by averaging the item responses, Higher scores suggest better trauma coping. | baseline, 4 weeks, 8 weeks, 18 weeks, 30 weeks |
Treatment expectancy | This outcome will be assessed with the Treatment Expectancy Questionnaire (TEQ), is a multidimensional scale measuring participants' expectations of medical and psychological treatments, scored by adding up scores on each item to yield a total score, with higher scores indicating stronger expectations. | baseline, 4 weeks, 8 weeks, 18 weeks, 30 weeks |
Mental health stigma | This outcome will be assessed with the Consumer Experiences of Stigma Questionnaire (CESQ), using a 5-point Likert scale (never to very often) for each item, with higher scores indicating greater stigma experienced. | baseline, 4 weeks, 8 weeks, 18 weeks, 30 weeks |
Medical mistrust | This outcome will be assessed with the Group-Based Medical Mistrust Scale (GBMMS), a 12-item measure that assesses suspicion of mainstream health care systems and health care professionals and the treatment provided to individuals. The response key is a Likert-type scale ranging from 1 (strongly disagree) to 5 (strongly agree) and the score range is 12 to 60. Higher scores suggest more medical distrust. | baseline, 4 weeks, 8 weeks, 18 weeks, 30 weeks |
Posttraumatic cognitions | This outcome will be assessed with the 9-item brief version of the posttraumatic cognitions inventory (PTCI-9). It is scored by averaging the responses to its nine items (a Likert-type scale from 1 to 7) to get a total score ranging from 1 to 7. Higher scores reflect greater endorsement of negative posttraumatic cognitions. | baseline, 4 weeks, 8 weeks, 18 weeks, 30 weeks |
Pathological fear extinction | This outcome will be assessed with the subjective units of distress (SUDs), a simple self-assessment tool used to quantify the intensity of distress or anxiety an individual feels at a particular moment. Scores can range from 0 to 10 with a score of 0 indicating complete calmness, while 10 signifies the highest level of distress imaginable. | baseline, 4 weeks, 8 weeks, 18 weeks, 30 weeks |
Geschiktheidscriteria
Leeftijd van deelnemers
Volwassene, Oudere volwassene
Minimumleeftijd
18 Years
Geslachten die in aanmerking komen voor de studie
Allen
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
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.
Boston Medical CenterNational Institute of Mental Health (NIMH)Centraal Contactpersoon
Contact: Sarah Valentine, PhD, 857 264 1102, [email protected]
1 Studielocaties in 1 landen
Massachusetts
Boston Medical Center, Boston, Massachusetts, 02118, United States
Sarah Valentine, PhD, Contact, 857-264-1102, [email protected]