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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04937504
Recruitment Status : Recruiting
First Posted : June 24, 2021
Last Update Posted : July 11, 2022
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Boston Medical Center

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.


Condition or disease Intervention/treatment Phase
Posttraumatic Stress Disorder Behavioral: STAIR-PC Group Behavioral: WebSTAIR Group Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Implementing a Skills Training Evidence-Based Treatment for Posttraumatic Stress Disorder in Primary Care (I-STEP)
Actual Study Start Date : June 29, 2021
Estimated Primary Completion Date : September 2023
Estimated Study Completion Date : September 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 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 12 weeks.
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.

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




Primary Outcome Measures :
  1. Posttraumatic Stress Disorder symptoms measured by PTSD Checklist for DSM-5 (PCL-5) [ Time Frame: Change from baseline, 3 months, and 9 months ]
    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.

  2. Feasibility based on retention [ Time Frame: 3 months ]
    The percent of participants who completed at least 90 minutes of an intervention by 3 months

  3. Acceptability measured by Client Satisfaction Questionnaire (CSQ-8) at 3 months [ Time Frame: 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.

  4. Acceptability measured by Client Satisfaction Questionnaire (CSQ-8) at 9 months [ Time Frame: 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 :
  1. General Mental Health Functioning measured by the Brief Symptom Inventory (BSI-18) [ Time Frame: Baseline, 3 months, 9 months ]
    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.

  2. Emotional Regulation measured by the Difficulties in Emotion Regulation Scale (DERS) [ Time Frame: Baseline, 3 months, 9 months ]
    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.

  3. Social Functioning measured by the Interpersonal Support Evaluation List - 12-item version (ISEL-12) [ Time Frame: Baseline, 3 months, 9 months ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04937504


Contacts
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Contact: Sarah Valentine, PhD (617) 414-5520 sarah.valentine@bmc.org
Contact: Laura Godfrey (617) 414-5520 laura.godfrey@bmc.org

Locations
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United States, Massachusetts
Boston Medical Center Clinics Recruiting
Boston, Massachusetts, United States, 02118
Contact: Sarah Valentine, PhD    617-414-5520    sarah.valentine@bmc.org   
Sponsors and Collaborators
Boston Medical Center
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: Sarah Valentine, PhD Boston Medical Center, Psychiatry Department
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Responsible Party: Boston Medical Center
ClinicalTrials.gov Identifier: NCT04937504    
Other Study ID Numbers: H-41323
K23MH117221-03 ( U.S. NIH Grant/Contract )
First Posted: June 24, 2021    Key Record Dates
Last Update Posted: July 11, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Boston Medical Center:
Mental health treatment
Primary Care
STAIR intervention
webSTAIR intervention
Additional relevant MeSH terms:
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Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders
Mental Disorders