N/A
N=60
Implementing a Skills Training Evidence-Based Treatment for Posttraumatic Stress Disorder in Primary Care
Posttraumatic Stress Disorder
Bottom Line
View on ClinicalTrials.gov: NCT04937504 ↗Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Feb 2025
Primary outcome: Primary: Posttraumatic Stress Disorder Symptoms Measured by PTSD Checklist for DSM-5 (PCL-5) — 61.48; 58.28; 39.12; 36.30 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- STAIR-PC Group (Behavioral); WebSTAIR Group (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Boston Medical Center
- Primary completion
- Feb 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Posttraumatic Stress Disorder Symptoms Measured by PTSD Checklist for DSM-5 (PCL-5) |
61.48; 58.28; 39.12; 36.30; 28.04; 36.39 | — |
| PRIMARY Feasibility Based on Retention |
24; 12 | — |
| PRIMARY Acceptability Measured by Client Satisfaction Questionnaire (CSQ-8) |
26.6; 23.7; 26.1; 23.3 | — |
| SECONDARY General Mental Health Functioning Measured by the Brief Symptom Inventory (BSI-18) |
37.77; 37.21; 25.80; 28.30; 20.13; 25.29 | — |
| SECONDARY Emotional Regulation Measured by the Difficulties in Emotion Regulation Scale (DERS) |
106.26; 109.83; 92.56; 97.80; 80.87; 87.35 | — |
| SECONDARY Trauma Symptoms as Assessed by the Trauma Symptoms of Discrimination Scale (TSDS) of Discrimination Scale, |
58.39; 56.34; 53.08; 48.30; 49.83; 55.38 | — |
| SECONDARY Social Functioning Measured by the Interpersonal Support Evaluation List - 12-item Version (ISEL-12) |
30.48; 31.26; 32.36; 31.77; 34.14; 33.50 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT04937504). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.