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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: Completed NA study, sponsored by Indiana University.
NCT05695209 is a NA study that has completed, run by Indiana University. The registered enrollment target is 30 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
The pain interference score averages seven ratings, 0 (does not interfere) to 10 (interferes completely), of interference with general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life.
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 |
What the finished NCT05695209 record still lists
NCT05695209 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 1 intervention - of which Coaching and Decision Aid is the first listed.
NCT05695209 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05695209's enrollment target sits among peer trials
30 1593rd of 2000 higher than 299 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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