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OpenTrials
Completed

NCT Number: NCT04937504

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

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.

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Key information

Conditions

Posttraumatic Stress Disorder Mental Disorders Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Boston Medical Center Clinics

Boston, Massachusetts, 02118, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

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

    Time frame: Baseline, 15 weeks, 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) so the PTSD checklist total scores can range from 0 to 80, where higher scores indicate higher severity of PTSD symptoms.

  2. Feasibility Based on Retention

    Time frame: 15 weeks

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

  3. Acceptability Measured by Client Satisfaction Questionnaire (CSQ-8)

    Time frame: 15 weeks, 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), and the total range for the CSQ-8 can be from 1 to 32 with higher scores indicating higher satisfaction.

Secondary outcomes

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

    Time frame: Baseline, 15 weeks, 9 months

    The Brief Symptom Inventory (BSI-18) is an 18-item self-report measure to assess psychological problems. The responses for each item ranges from Not At All (0) to Extremely (4), so the toal scores can range from 0 to 72. Higher total scores indicate higher severity of psychological distress.

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

    Time frame: Baseline, 15 weeks, 9 months

    The Difficulties in Emotion Regulation Scale (DERS) is a 36-item self-report measure of emotion regulation difficulties. Individual item responses range from Almost never (1) to Almost always (5), creating a potential total score range for the DERS of 36 to 180. Higher total scores indicate higher symptom severity.

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

    Time frame: Baseline, 15 weeks, 9 months

    The TSDS assesses discriminatory distress and anxiety-related trauma symptoms. It includes 21 items, each of which is rated on a 4-point scale ranging from 1 (Never) to 4 (Often). The total score of the TSDS is calculated by adding up the scores from all items and can range from 21 to 84. HIgher scores are asociated with more trauma.

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

    Time frame: Baseline, 15 weeks, 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. Each item response ranges from Definitely false (1) to Definitely true (4), creating a total score range of 12 to 48. Higher total scores indicate greater social supports.

Sponsors and collaborators

Lead sponsor

Boston Medical Center

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

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

Acronym: I-STEP

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Jun 24, 2021
Registry last updated
Feb 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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