Clinical trial NCT04937504: Implementing a Skills Training Evidence-Based Treatment for Posttraumatic Stress Disorder in Primary Care
Official title: Implementing a Skills Training Evidence-Based Treatment for Posttraumatic Stress Disorder in Primary Care (I-STEP)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Posttraumatic Stress Disorder
Keywords: Mental health treatment
Primary Care
STAIR intervention
webSTAIR intervention
Lead sponsor: Boston Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2021-06-24
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A majority of residents in low income communities have been exposed to a potentially traumatic event, and up to half (30-50%) of trauma-exposed residents in safety net clinical settings meet criteria for posttraumatic stress disorder (PTSD). Despite this, only 13% receive treatment. Poor access to PTSD treatment is due to a shortage of mental health specialists.

This study aims to evaluate the implementation and effectiveness of a brief, cognitive-behavioral intervention for posttraumatic stress disorder (PTSD)-Skills Training in Affective and Interpersonal Regulation (STAIR)- that will be offered in Boston Medical Center (BMC)'s primary care clinics as the new standard of care following integrated behavioral healthcare (IBH) therapist training. In response to clinician capacity concerns and the impact of the COVID-19 pandemic, we will be offering the intervention in both clinician-administered and self-paced, web-administered formats. The evidence base suggests that STAIR, delivered both synchronously (in-person/telehealth STAIR) and asynchronously (webSTAIR), is associated with significant improvements in PTSD and depression symptoms.

Detailed description: Participants who enroll in the study will be randomized to either in-person/telehealth STAIR or webSTAIR. Those who do not enroll in the study will still be able to receive STAIR in person or via telehealth as part of usual care.

Participant data will be for 9 months. Treatment plans will continue to be determined by usual care providers, the study has no involvement in any decisions regarding care. This means that a participant's IBH therapist can continue the therapy, offer a different treatment option, or refer to other services at any time in the study and after the study is completed. At any time, patients can also choose to change their treatment plans, for example from webSTAIR to in-person/telehealth STAIR, or to another treatment option in the clinic. Access to webSTAIR will be discontinued at 9 months.

The investigators hypothesize that offering a low intensity treatment for PTSD through primary care will improve access to and engagement in care for PTSD among BMC's patient population. The feasibility of two modes of treatment delivery will be compared, while gathering further evidence of the effectiveness of the intervention in our local setting. It is also hypothesized that both formats will be effective in reducing mental health symptoms, while webSTAIR may have some advantages in regard to uptake and long-term sustainability in usual care.

Eligibility criteria: Inclusion Criteria:

* Client seen in integrated behavioral health in Boston Medical Center's General Internal Medicine and Family Medicine clinics.
* Able to receive therapy in English (per participant report)
* Exposure to trauma (as indicated by Life Events Checklist (LEC) for the Diagnostic and Statistical Manual of Mental Disorders (DSM) DSM-5 \[LEC-5\])
* Subthreshold or Full Criteria for PTSD (as indicated by the PTSD Checklist Posttraumatic Stress Disorder Checklist (PCL) for the DSM-5 \[PCL-5\])
* Reasonable to access to technology needed to support either condition (e.g., phone, computer, internet access).

Exclusion Criteria:

* Patient is not appropriate for outpatient level of care / standard of care provided in Integrated behavioral health (IBH) per clinician judgement
* Currently receiving cognitive behavioral therapy for PTSD elsewhere e.g., cognitive processing theory (CPT), prolonged exposure (PE), eye movement desensitization and reprocessing (EMDR).
* Patient is experiencing bereavement (death of someone close) as primary clinical concern, and is therefore not a good fit for a PTSD-specific treatment at this time.

Primary outcomes:
measure: Posttraumatic Stress Disorder Symptoms Measured by PTSD Checklist for DSM-5 (PCL-5)
timeFrame: Baseline, 15 weeks, and 9 months
measure: Feasibility Based on Retention
timeFrame: 15 weeks
measure: Acceptability Measured by Client Satisfaction Questionnaire (CSQ-8)
timeFrame: 15 weeks, 9 months
Secondary outcomes:
measure: General Mental Health Functioning Measured by the Brief Symptom Inventory (BSI-18)
timeFrame: Baseline, 15 weeks, 9 months
measure: Emotional Regulation Measured by the Difficulties in Emotion Regulation Scale (DERS)
timeFrame: Baseline, 15 weeks, 9 months
measure: Trauma Symptoms as Assessed by the Trauma Symptoms of Discrimination Scale (TSDS) of Discrimination Scale,
timeFrame: Baseline, 15 weeks, 9 months
measure: Social Functioning Measured by the Interpersonal Support Evaluation List - 12-item Version (ISEL-12)
timeFrame: Baseline, 15 weeks, 9 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Medical Center Clinics
state: Massachusetts
Study officials:
affiliation: Boston Medical Center, Psychiatry Department
name: Sarah Valentine, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Godfrey LB, Cloitre M, Elwy AR, Fortuna LR, Fuchs C, Valentine SE. Study protocol for a hybrid 1 effectiveness-implementation trial of Brief Skills Training in Affective and Interpersonal Regulation (Brief STAIR) and web-administered STAIR (webSTAIR) for posttraumatic stress disorder in integrated primary care. Contemp Clin Trials. 2023 Aug;131:107241. doi: 10.1016/j.cct.2023.107241. Epub 2023 May 25.