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

NCT ID: NCT04937504

Last Updated: 2025-02-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-29
• Study Completion Date: 2024-02-26

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.

Conditions

Posttraumatic Stress Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

STAIR-PC Group

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.

Group Type: ACTIVE_COMPARATOR

STAIR-PC Group

Intervention Type: 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.

WebSTAIR Group

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

Group Type: EXPERIMENTAL

WebSTAIR Group

Intervention Type: 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.

Interventions

STAIR-PC Group

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.

Intervention Type: BEHAVIORAL

WebSTAIR Group

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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

Boston Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sarah Valentine, PhD

Role: PRINCIPAL_INVESTIGATOR

Boston Medical Center, Psychiatry Department

Locations

Boston Medical Center Clinics

Boston, Massachusetts, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 37244367 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

K23MH117221-03

Identifier Type: NIH

Identifier Source: secondary_id

View Link

H-41323

Identifier Type: -

Identifier Source: org_study_id