Ignite Creation Date:
2024-07-17 @ 10:41 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06500780
Status:
RECRUITING
Last Update Posted:
2024-07-15
First Post:
2024-07-08
Brief Title:
Equity Using Interventions for Pain and Depression
Sponsor:
Indiana University
Organization:
Indiana University
Study Overview
Official Title:
Equity Using Interventions for Pain and Depression EQUIPD - Phase 2
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EQUIPD
Brief Summary:
This project is part of the NIH Helping to End Addiction Long-term HEAL initiative httpshealnihgov This pilot randomized controlled trial RCT is phase 2 of a two-phase 5-year project with the overarching goal of testing a decision aid DAcoaching 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 will aim to enroll up to 355 Black patients with comorbid chronic musculoskeletal pain and depression in primary care from an urban safety-net health system Eskenazi in order to randomize at least 304 patients After the baseline assessment patients randomized to the intervention will be asked to participate in 4 coaching sessions over approximately 12 weeks Sessions will use 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 will be integrated into these sessions which will facilitate discussion of these options with their PCP The first 3 sessions take place prior to the patients next scheduled PCP visit the final session occurs after this visit Assessments will be conducted at baseline 3 months ie after completing the final coaching session and 6 months
Patients randomized to the wait-list control group will receive usual care in addition to study assessments at baseline 3 months and 6 months After completing the final assessment they will then be given the DA and offered a 20-minute coaching session to walk them through it
This 2-arm pilot trial will aim to enroll up to 355 Black patients with comorbid chronic musculoskeletal pain and depression in primary care from an urban safety-net health system Eskenazi in order to randomize at least 304 patients After the baseline assessment patients randomized to the intervention will be asked to participate in 4 coaching sessions over approximately 12 weeks Sessions will use 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 will be integrated into these sessions which will facilitate discussion of these options with their PCP The first 3 sessions take place prior to the patients next scheduled PCP visit the final session occurs after this visit Assessments will be conducted at baseline 3 months ie after completing the final coaching session and 6 months
Patients randomized to the wait-list control group will receive usual care in addition to study assessments at baseline 3 months and 6 months After completing the final assessment they will then be given the DA and offered a 20-minute coaching session to walk them through it
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 4R33NR020845-02 | NIH | None | None |