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NCT04937504 · ClinicalTrials.gov registry record · NA

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

A NA study, sponsored by Boston Medical Center.

Completed
Registry status
NA
Development phase
60
Enrollment target

NCT04937504: Completed NA study, sponsored by Boston Medical Center.

NCT04937504 is a NA study that has completed, run by Boston Medical Center. The registered enrollment target is 60 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04937504, a NA study, has completed, sponsored by Boston Medical Center.

COMPLETED
Registry status
NA
Development phase
60 participants
Enrollment target

Study 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.

Primary Outcome

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.

Interventions

  • BEHAVIORAL STAIR-PC Group
  • BEHAVIORAL WebSTAIR Group

Trial Details

FieldValue
Enrollment Target 60 participants
Start Date 2021-06-29
Est. Completion 2024-02-26
Phase NA
Boston Medical Center

253 total trials

What the finished NCT04937504 record still lists

NCT04937504 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).

The record links to 0 conditions, and to 2 interventions - of which STAIR-PC Group is the first listed.

NCT04937504 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04937504 about?

NCT04937504 is a clinical study titled "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 P...

What is the current status of trial NCT04937504?

This trial is currently completed. It is a NA study. The enrollment target is 60 participants. The study started on 2021-06-29. Estimated completion is 2024-02-26.

What interventions are being tested in trial NCT04937504?

The interventions under investigation include: STAIR-PC Group (BEHAVIORAL), WebSTAIR Group (BEHAVIORAL).

Who is sponsoring clinical trial NCT04937504?

This trial is sponsored by Boston Medical Center, which has 253 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04937504's enrollment target sits among peer trials

60 1164th of 2000 higher than 745 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04937504, the US trial registry maintained by the National Library of Medicine. NCT04937504 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.