Implementing a Skills Training Evidence-Based Treatment for Posttraumatic Stress Disorder in Primary Care

NCT04937504 | Completed Results

• 2 other identifiers: H-41323K23MH117221-03
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Posttraumatic Stress Disorder

Keywords

Mental health treatment; Primary Care; STAIR intervention; webSTAIR intervention

Outcome Measures

Primary Outcomes (3)

• Posttraumatic Stress Disorder Symptoms Measured by PTSD Checklist for DSM-5 (PCL-5)

  The PTSD Checklist for DSM-5 (PCL-5) is a 20-item self-report measure that assesses the 20 DSM-5 symptoms. The PCL-5 scale ranges from Not At All (0) to Extremely (4) so the PTSD checklist total scores can range from 0 to 80, where higher scores indicate higher severity of PTSD symptoms.

  Baseline, 15 weeks, and 9 months

• Feasibility Based on Retention

  The number of participants who completed at least 90 minutes of an intervention by 15 weeks

  15 weeks

• Acceptability Measured by Client Satisfaction Questionnaire (CSQ-8)

  The Client Satisfaction Questionnaire (CSQ-8) is an 8-item survey to measure and assess consumer satisfaction with health and human services. Response options differ for each item, the scale ranges from very negative response (1) to a very positive response (4), and the total range for the CSQ-8 can be from 1 to 32 with higher scores indicating higher satisfaction.

  15 weeks, 9 months

Secondary Outcomes (4)

• General Mental Health Functioning Measured by the Brief Symptom Inventory (BSI-18)

  Baseline, 15 weeks, 9 months

• Emotional Regulation Measured by the Difficulties in Emotion Regulation Scale (DERS)

  Baseline, 15 weeks, 9 months

• Trauma Symptoms as Assessed by the Trauma Symptoms of Discrimination Scale (TSDS) of Discrimination Scale,

  Baseline, 15 weeks, 9 months

• Social Functioning Measured by the Interpersonal Support Evaluation List - 12-item Version (ISEL-12)

  Baseline, 15 weeks, 9 months

Study Arms (2)

STAIR-PC Group

ACTIVE COMPARATOR

Participants in the Skills Training in Affective and Interpersonal Regulation for Primary Care (STAIR-PC) group will complete five (30 minute each) therapist-led sessions in-person or via Telehealth for up to 15 weeks.

Behavioral: STAIR-PC Group

WebSTAIR Group

EXPERIMENTAL

Participants in the WebSTAIR group will complete 10 self-guided, web-based modules for up to 15 weeks.

Behavioral: WebSTAIR Group

Interventions

STAIR-PC Group BEHAVIORAL

Skills Training in Affective and Interpersonal Regulation for Primary Care (STAIR-PC) is a face-to-face, individual, brief (5 session) therapy adapted from the STAIR program. STAIR-PC is an appropriate treatment for individuals who have experienced traumatic stressors, and addresses symptom targets by teaching skills to improve coping with emotions and strengthen interpersonal relationships.

STAIR-PC Group

WebSTAIR Group BEHAVIORAL

WebSTAIR is a web-based self-help program adapted from the STAIR program for individuals who have experienced traumatic stressors. WebSTAIR contains 10 self-guided interactive modules that teach skills to improve coping with emotions and strengthen interpersonal relationships.

WebSTAIR Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boston Medical Center: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Boston Medical Center Clinics

Boston, Massachusetts, 02118, United States

Location

Related Publications (1)

• 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.

  PMID: 37244367 BACKGROUND

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Results Point of Contact

• Title: Sarah Valentine, PhD
• Organization: Boston Medical Center, Psychiatry Department

sarah.valentine@bmc.org

(617) 414-1989

Study Officials

• Sarah Valentine, PhD

  Boston Medical Center, Psychiatry Department

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2021
• First Posted: June 24, 2021
• Study Start: June 29, 2021
• Primary Completion: February 26, 2024
• Study Completion: February 26, 2024
• Last Updated: February 14, 2025
• Results First Posted: February 14, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)