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

Primary Purpose

Posttraumatic Stress Disorder

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
STAIR-PC Group
WebSTAIR Group
Sponsored by
Boston Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Posttraumatic Stress Disorder focused on measuring Mental health treatment, Primary Care, STAIR intervention, webSTAIR intervention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Boston Medical Center Clinics

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

STAIR-PC Group

WebSTAIR Group

Arm Description

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 12 weeks.

Participants in the WebSTAIR group will complete 10 self-guided, web-based modules for up to 12 weeks.

Outcomes

Primary Outcome Measures

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.
Feasibility based on retention
The percent of participants who completed at least 90 minutes of an intervention by 3 months
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.
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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
June 15, 2021
Last Updated
May 30, 2023
Sponsor
Boston Medical Center
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT04937504
Brief Title
Implementing a Skills Training Evidence-Based Treatment for Posttraumatic Stress Disorder in Primary Care
Acronym
I-STEP
Official Title
Implementing a Skills Training Evidence-Based Treatment for Posttraumatic Stress Disorder in Primary Care (I-STEP)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 29, 2021 (Actual)
Primary Completion Date
February 2024 (Anticipated)
Study Completion Date
February 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston Medical Center
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Posttraumatic Stress Disorder
Keywords
Mental health treatment, Primary Care, STAIR intervention, webSTAIR intervention

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
STAIR-PC Group
Arm Type
Active Comparator
Arm Description
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 12 weeks.
Arm Title
WebSTAIR Group
Arm Type
Experimental
Arm Description
Participants in the WebSTAIR group will complete 10 self-guided, web-based modules for up to 12 weeks.
Intervention Type
Behavioral
Intervention Name(s)
STAIR-PC Group
Intervention Description
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
Intervention Name(s)
WebSTAIR Group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Posttraumatic Stress Disorder symptoms measured by PTSD Checklist for DSM-5 (PCL-5)
Description
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.
Time Frame
Change from baseline, 3 months, and 9 months
Title
Feasibility based on retention
Description
The percent of participants who completed at least 90 minutes of an intervention by 3 months
Time Frame
3 months
Title
Acceptability measured by Client Satisfaction Questionnaire (CSQ-8) at 3 months
Description
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.
Time Frame
3 months.
Title
Acceptability measured by Client Satisfaction Questionnaire (CSQ-8) at 9 months
Description
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.
Time Frame
9 months.
Secondary Outcome Measure Information:
Title
General Mental Health Functioning measured by the Brief Symptom Inventory (BSI-18)
Description
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.
Time Frame
Baseline, 3 months, 9 months
Title
Emotional Regulation measured by the Difficulties in Emotion Regulation Scale (DERS)
Description
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.
Time Frame
Baseline, 3 months, 9 months
Title
Social Functioning measured by the Interpersonal Support Evaluation List - 12-item version (ISEL-12)
Description
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.
Time Frame
Baseline, 3 months, 9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sarah Valentine, PhD
Organizational Affiliation
Boston Medical Center, Psychiatry Department
Official's Role
Principal Investigator
Facility Information:
Facility Name
Boston Medical Center Clinics
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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