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NCT05695209 · ClinicalTrials.gov registry record · NA
Equity Using Interventions for Pain and Depression - Pilot Study
A NA study, sponsored by Indiana University.
- Completed
- Registry status
- NA
- Development phase
- 30
- Enrollment target
NCT05695209 is a NA study that has completed, run by Indiana University. The registered enrollment target is 30 participants.
The verdict
NCT05695209, a NA study, has completed, sponsored by Indiana University.
- COMPLETED
- Registry status
- NA
- Development phase
- 30 participants
- Enrollment target
Study Summary
This project is part of the NIH Helping to End Addiction Long-term (HEAL) initiative (https://heal.nih.gov/). This pilot randomized controlled trial (RCT) is part of phase 1 of a two-phase, 5-year project with the overarching goal of testing a decision aid (DA)/coaching intervention, tailored to Black patients with comorbid chronic pain and depression, to encourage use of and adherence to nonpharmacological pain treatments (NPTs). This 2-arm pilot trial randomized 30 Black patients with comorbid chronic musculoskeletal pain and depression in primary care from an urban safety-net health system. After the baseline assessment, patients randomized to the intervention were asked to participate in 4 coaching sessions over approximately 12 weeks. Sessions used Motivational Interviewing principles to foster openness to NPTs and self-efficacy by helping patients identify their goals and priorities, understand their NPT options, prepare them to discuss and choose options with their primary care providers (PCPs), and reinforce these choices to foster maintenance of these changes. DA contents were integrated into these sessions, which facilitated discussion of these options with their PCP. The first 3 sessions ideally took place prior to the patient's next scheduled PCP visit; the final session occurred after this visit. Assessments were conducted at baseline, 3 months (i.e., after completing the final coaching session), and 6 months. Patients randomized to the wait-list control group received usual care (in addition to study assessments at baseline, 3 months, and 6 months). After completing the final assessment, they were given the DA and offered a 20-minute coaching session to walk them through it (patients could decline the coaching session).
Interventions
- BEHAVIORAL Coaching and Decision Aid
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2023-06-22 |
| Est. Completion | 2024-04-23 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05695209
The ClinicalTrials.gov registry entry for NCT05695209 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Indiana University, which has 890 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Coaching and Decision Aid is the first listed.
NCT05695209 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05695209 about?
NCT05695209 is a clinical study titled "Equity Using Interventions for Pain and Depression - Pilot Study". This project is part of the NIH Helping to End Addiction Long-term (HEAL) initiative (https://heal.nih.gov/). This pilot randomized controlled trial (RCT) is part of phase 1 of a two-phase, 5-year project with the overarching goal of testing a decision aid (DA)/coaching intervention, tailored to Bla...
What is the current status of trial NCT05695209?
This trial is currently completed. It is a NA study. The enrollment target is 30 participants. The study started on 2023-06-22. Estimated completion is 2024-04-23.
What interventions are being tested in trial NCT05695209?
The interventions under investigation include: Coaching and Decision Aid (BEHAVIORAL).
Who is sponsoring clinical trial NCT05695209?
This trial is sponsored by Indiana University, which has 890 total clinical trials registered on ClinicalTrials.gov.
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