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).
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
428
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 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.
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.
Boston Medical Center
Boston, Massachusetts, United States
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
Treatment retention
as the proportion (%) of participant who complete 60% of interventions in the treatment windows.
Time frame: 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.
Time frame: 4 weeks, 8 weeks, 18 weeks, 30 weeks
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.
Time frame: 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.
Time frame: baseline, 4 weeks, 8 weeks, 18 weeks, 30 weeks
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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.
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
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
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.
Time frame: 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.
Time frame: baseline, 4 weeks, 8 weeks, 18 weeks, 30 weeks