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Stepped Care for Posttraumatic Stress Disorder Study

ConditionPost Traumatic Stress Disorder
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBoston Medical Center

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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 design

Design model

Sequential

Treatments tested in this trial

  • 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.

Treatment groups

428 Participants
are divided into 4 treatment groups
Group A: webSTAIR to WETActive comparator 2 interventions
Group B: webSTAIR+coaching to WETActive comparator 2 interventions
Group C: WebSTAIR to Brief STAIRActive comparator 2 interventions
Group D: WebSTAIR+coaching to Brief STAIRActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
baseline, 4 weeks, 8 weeks, 18 weeks, 30 weeks
2

Treatment retention

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

Time frame
4 weeks, 8 weeks, 18 weeks
3

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.

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

Secondary outcomes

1

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.

Time frame
baseline, 4 weeks, 8 weeks, 18 weeks, 30 weeks
2

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.

Time frame
baseline, 4 weeks, 8 weeks, 18 weeks, 30 weeks
3

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.

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

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.

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Boston Medical Center

Lead sponsor

National Institute of Mental Health (NIMH)

Collaborator

Source ClinicalTrials.gov
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