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Behavioral Intervention

Coaching for Chronic Pain and Depression (EQUIPD Trial)

N/A
Recruiting
Led By Marianne Matthias, PHd
Research Sponsored by Indiana University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients must have musculoskeletal pain in the low back, cervical spine, or extremities (hip, knee, shoulder) for ≥3 months
Patients must have at least moderate pain intensity and interference with function, defined by a score ≥4 on the Pain, Enjoyment of Life and General Activity scale (PEG)
Must not have
Patients with severe hearing/speech or cognitive impairment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to test a coaching intervention for Black patients with chronic pain and depression. Patients will receive coaching sessions to help them understand and choose non-drug treatments for pain. The trial will enroll

Who is the study for?
This trial is for Black patients with both chronic musculoskeletal pain and depression. Participants will be from an urban safety-net health system and must not have started any nonpharmacological pain treatments (NPTs) before the study.
What is being tested?
The trial tests a decision aid/coaching intervention tailored to encourage use of NPTs among Black patients with chronic pain and depression. It compares this approach against usual care in a randomized controlled setup over approximately 6 months.
What are the potential side effects?
Since the interventions involve coaching sessions using Motivational Interviewing principles, there are no direct medical side effects expected as it's non-pharmacological. However, participants may experience emotional or psychological responses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have had pain in my back, neck, or limbs for over 3 months.
Select...
My pain is moderate or severe, affecting my daily activities.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have severe hearing, speech, or cognitive issues.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change from Baseline Brief Pain Inventory (BPI) Interference Scale at 3 months
Change from Baseline Brief Pain Inventory (BPI) Interference Scale at 6 months
Change from Baseline Patient Health Questionnaire (PHQ)-8 at 3 months
+1 more
Secondary study objectives
Change from Baseline Altarum Consumer Engagement (ACE) Measure at 3 months
Change from Baseline Altarum Consumer Engagement (ACE) Measure at 6 months
Change from Baseline Brief Pain Inventory (BPI) Intensity Scale at 3 months
+28 more
Other study objectives
Change from Baseline Perceived Efficacy in Patient-Physician Interactions Scale (PEPPI-5) at 3 months
Change from Baseline Perceived Efficacy in Patient-Physician Interactions Scale (PEPPI-5) at 6 months

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Coaching and Decision AidExperimental Treatment1 Intervention
Intervention group (Individual coaching sessions and Decision Aid)
Group II: ControlActive Control1 Intervention
Wait-list control group
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Coaching and Decision Aid
2023
N/A
~30

Find a Location

Who is running the clinical trial?

Indiana UniversityLead Sponsor
1,037 Previous Clinical Trials
1,218,669 Total Patients Enrolled
2 Trials studying Musculoskeletal Pain
830 Patients Enrolled for Musculoskeletal Pain
National Institute of Nursing Research (NINR)NIH
600 Previous Clinical Trials
10,377,469 Total Patients Enrolled
3 Trials studying Musculoskeletal Pain
362 Patients Enrolled for Musculoskeletal Pain
Marianne Matthias, PHdPrincipal InvestigatorIndiana University
~203 spots leftby May 2027
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