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

Posttraumatic Stress Disorder Clinical Trial

— I-STEP  

Official title:

Implementing a Skills Training Evidence-Based Treatment for Posttraumatic Stress Disorder in Primary Care (I-STEP)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04937504
• Other study ID #: H-41323
• Secondary ID: K23MH117221-03
• Status: Completed
• Phase: N/A
• Start date: June 29, 2021
• Est. completion date: February 26, 2024

Study information

• Verified date: February 2024
• Source: Boston Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: February 26, 2024
• Est. primary completion date: February 26, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 for the DSM-5 [LEC-5])

• Subthreshold or Full Criteria for PTSD (as indicated by the PTSD Checklist 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 IBH (per clinician judgement)

• Currently receiving cognitive behavioral therapy for PTSD elsewhere (e.g., CPT, PE, 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.

Related Conditions & MeSH terms

• Posttraumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Behavioral:
• 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.
• 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.

Locations

Country	Name	City	State
United States	Boston Medical Center Clinics	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Boston Medical Center	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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), where higher scores indicate higher severity of PTSD symptoms.	Change from baseline, 3 months, and 9 months
Primary	Feasibility based on retention	The percent of participants who completed at least 90 minutes of an intervention by 3 months	3 months
Primary	Acceptability measured by Client Satisfaction Questionnaire (CSQ-8) at 3 months	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), with higher scores indicating higher satisfaction.	3 months.
Primary	Acceptability measured by Client Satisfaction Questionnaire (CSQ-8) at 9 months	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), with higher scores indicating higher satisfaction.	9 months.
Secondary	General Mental Health Functioning measured by the Brief Symptom Inventory (BSI-18)	The Brief Symptom Inventory (BSI-18) is an 18-item self-report measure to assess psychological problems. The scale ranges from Not At All (0) to Extremely (4), where higher scores indicate higher severity of psychological distress.	Baseline, 3 months, 9 months
Secondary	Emotional Regulation measured by the Difficulties in Emotion Regulation Scale (DERS)	The Difficulties in Emotion Regulation Scale (DERS) is a 36-item self-report measure of emotion regulation difficulties. The scale ranges from Almost Never (1) to Almost Always (5), where higher scores indicate higher symptom severity.	Baseline, 3 months, 9 months
Secondary	Social Functioning measured by the Interpersonal Support Evaluation List - 12-item version (ISEL-12)	The Interpersonal Support Evaluation List - 12-item version (ISEL-12) is a 12-item self-report measure to assess perceptions of social supports. The scale ranges from Definitely False (1) to Definitely True (4), where higher scores indicate greater social supports.	Baseline, 3 months, 9 months