Post Traumatic Stress DisorderSTEPPSNCT06947538
Stepped Care for Posttraumatic Stress Disorder Study
A study testing webSTAIR, WebSTAIR plus coaching and Clinician administered Brief STAIR in people with Post Traumatic Stress Disorder, run by Boston Medical Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post Traumatic Stress Disorder
- What is being tested?
- webSTAIR, WebSTAIR plus coaching and Clinician administered Brief STAIR
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 428 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Mar 2026to Jun 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 12Show fewer
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Boston Medical Center
Boston, Massachusetts, 02118
Sarah Valentine, PhD, 857-264-1102, sarah.valentine@bmc.org
About this study
Official title: Adaptive Interventions to Improve Posttraumatic Stress Disorder (PTSD) Treatment Access, Engagement, and Effectiveness in Routine Care
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).
Read the 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
- Conditions
- Post Traumatic Stress Disorder
- Being tested
- webSTAIR, WebSTAIR plus coaching, Clinician administered Brief STAIR, Clinician administered WET
- Keywords
- Stepped Care, Skills training in affective & interpersonal regulation (STAIR), Digital Mental Health Intervention, Written Exposure Therapy (WET), Adaptive Interventions
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
webSTAIRBehavioural
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.
WebSTAIR plus coachingBehavioural
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 STAIRBehavioural
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.
Clinician administered WETBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| webSTAIR to WET | Active comparator | 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. Receives: Behavioral: webSTAIR; Behavioral: Clinician administered WET |
| webSTAIR+coaching to WET | Active comparator | 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 for responders. Receives: Behavioral: WebSTAIR plus coaching; Behavioral: Clinician administered WET |
| WebSTAIR to Brief STAIR | Active comparator | First, offer skills-focused DMHI; then add clinician-administered skills-focused behavioral treatment for nonresponders and continue skills-focused DMHI for responders. Receives: Behavioral: webSTAIR; Behavioral: Clinician administered Brief STAIR |
| WebSTAIR+coaching to Brief STAIR | Active comparator | 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. Receives: Behavioral: WebSTAIR plus coaching; Behavioral: Clinician administered Brief STAIR |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 4 weeks, 8 weeks, 18 weeks, 30 weeks
Secondary outcomes (6)
Trauma coping self-efficacy
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: baseline, 4 weeks, 8 weeks, 18 weeks, 30 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2025
- Study start12 Mar 2026
- Primary completionJun 2029 (estimated)
- Study completionJun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Traumatic Stress DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- This study uses a Sequential, Multiple Assignment, Randomized Trial (SMART) design. Participants are randomized at baseline to either WebSTAIR (self-managed) or WebSTAIR with community health worker coaching. Participants who do not respond to these treatments by 8 weeks, will be re-randomized to either Brief STAIR or WET.
- Masking
- None (open label)
- Enrolment
- 428 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Sarah Valentine, PhD, Principal investigator, Boston Medical Center, Psychiatry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06947538
- Sponsor's protocol ID
- H-45694
- Other IDs
- 1R01MH138549-01
- Acronym
- STEPPS
- Status last verified
- Jul 2026
- First submitted
- 21 Apr 2025
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptive Interventions to Improve Posttraumatic Stress Disorder (PTSD) Treatment Access, Engagement, and Effectiveness in Routine Care
- ClinicalTrials.gov ID
- NCT06947538
- Acronym / sponsor ID
- STEPPS / H-45694
- Conditions
- Post Traumatic Stress Disorder
- Keywords
- Stepped Care, Skills training in affective & interpersonal regulation (STAIR), Digital Mental Health Intervention, Written Exposure Therapy (WET), Adaptive Interventions
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 428 participants (estimated)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 12 Mar 2026 (actual)
- Primary completion
- Jun 2029 (estimated)
- Study completion
- Jun 2029 (estimated)
- First posted
- 27 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- This study uses a Sequential, Multiple Assignment, Randomized Trial (SMART) design. Participants are randomized at baseline to either WebSTAIR (self-managed) or WebSTAIR with community health worker coaching. Participants who do not respond to these treatments by 8 weeks, will be re-randomized to either Brief STAIR or WET.
| Arm | Type | Receives |
|---|---|---|
| webSTAIR to WET | Active comparator | Behavioral: webSTAIR, Behavioral: Clinician administered WETFirst, 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+coaching to WET | Active comparator | Behavioral: WebSTAIR plus coaching, Behavioral: Clinician administered WETFirst, 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 for responders. |
| WebSTAIR to Brief STAIR | Active comparator | Behavioral: webSTAIR, Behavioral: Clinician administered Brief STAIRFirst, offer skills-focused DMHI; then add clinician-administered skills-focused behavioral treatment for nonresponders and continue skills-focused DMHI for responders. |
| WebSTAIR+coaching to Brief STAIR | Active comparator | Behavioral: WebSTAIR plus coaching, Behavioral: Clinician administered Brief STAIRFirst, 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| webSTAIRWebSTAIR 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. | Behavioural | WebSTAIR to Brief STAIR, webSTAIR to WET |
| WebSTAIR plus coachingWebSTAIR 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. | Behavioural | WebSTAIR+coaching to Brief STAIR, webSTAIR+coaching to WET |
| Clinician administered Brief STAIRBrief 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. | Behavioural | WebSTAIR to Brief STAIR, WebSTAIR+coaching to Brief STAIR |
| Clinician administered WETWET 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. | Behavioural | webSTAIR to WET, webSTAIR+coaching to WET |
Primary outcome
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.
6 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sarah Valentine, PhD principal investigator
Boston Medical Center, Psychiatry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing webSTAIR, WebSTAIR plus coaching and Clinician administered Brief STAIR in people with Post Traumatic Stress Disorder, run by Boston Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sarah Valentine, PhD (857 264 1102, sarah.valentine@bmc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PTSD symptom severity (time frame: baseline, 4 weeks, 8 weeks, 18 weeks, 30 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2026.