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NCT Number: NCT06947538

Stepped Care for Posttraumatic Stress Disorder Study

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).

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Key information

Conditions

Post Traumatic Stress Disorder Mental Disorders Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location status: Recruiting

Location contact

Sarah Valentine, PhD

CONTACT

[email protected]

857-264-1102

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

webSTAIR

Behavioral

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 coaching

Behavioral

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

Behavioral

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 WET

Behavioral

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 outcomes

  1. 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.

  2. Treatment retention

    Time frame: 4 weeks, 8 weeks, 18 weeks

    as the proportion (%) of participant who complete 60% of interventions in the treatment windows.

  3. 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.

Secondary outcomes

  1. Trauma coping self-efficacy

    Time frame: baseline, 4 weeks, 8 weeks, 18 weeks, 30 weeks

    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.

  2. Treatment expectancy

    Time frame: baseline, 4 weeks, 8 weeks, 18 weeks, 30 weeks

    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.

  3. Mental health stigma

    Time frame: baseline, 4 weeks, 8 weeks, 18 weeks, 30 weeks

    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.

  4. Medical mistrust

    Time frame: baseline, 4 weeks, 8 weeks, 18 weeks, 30 weeks

    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.

  5. Posttraumatic cognitions

    Time frame: baseline, 4 weeks, 8 weeks, 18 weeks, 30 weeks

    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.

  6. Pathological fear extinction

    Time frame: baseline, 4 weeks, 8 weeks, 18 weeks, 30 weeks

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Sarah Valentine, PhD

CONTACT

[email protected]

857 264 1102

Sponsors and collaborators

Lead sponsor

Boston Medical Center

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Adaptive Interventions to Improve Posttraumatic Stress Disorder (PTSD) Treatment Access, Engagement, and Effectiveness in Routine Care

Acronym: STEPPS

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Apr 27, 2025
Registry last updated
Jul 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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