← Back to Search

Coaching + Decision Aid for Chronic Pain and Depression (EQUIPD-Pilot Trial)

N/A

Waitlist Available

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 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), a 3-item measure of pain intensity, interference with enjoyment of life, and interference with general activity

Eligible patients must have musculoskeletal pain in the low back, cervical spine, or extremities (hip, knee, shoulder) for ≥3 months

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

EQUIPD-Pilot Trial Summary

This trial will examine if a decision aid/coaching intervention tailored to Black patients with chronic pain & depression can encourage use & adherence to non-pharm treatments.

Who is the study for?

This trial is for Black patients with chronic musculoskeletal pain and depression, who have access to a phone and are open to new pain treatments. They must have moderate pain and mild depression as measured by specific scales, and be scheduled to see their primary care provider soon. Those with severe medical conditions or past participation in related studies are excluded.Check my eligibility

What is being tested?

The study tests a decision aid/coaching intervention tailored for Black patients with chronic pain and depression, aiming to improve the use of nonpharmacological treatments. Participants will either receive coaching sessions before a primary care visit or be placed on a wait-list control group receiving usual care.See study design

What are the potential side effects?

Since the interventions involve coaching sessions and decision aids rather than medications, traditional side effects are not expected. However, participants may experience emotional discomfort discussing personal health issues during these sessions.

EQUIPD-Pilot Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I experience moderate to severe pain that affects my daily activities and enjoyment of life.

Select...

I have had muscle or joint pain in my back, neck, or limbs for over 3 months.

Select...

I experience moderate to severe pain that affects my daily life.

Select...

I have had pain in my back, neck, or limbs for more than 3 months.

EQUIPD-Pilot Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change from Baseline Brief Pain Inventory (BPI) Interference Scale at 3 months

Change from Baseline Brief Pain Inventory (BPI) Interference Scale at 6 months

Secondary outcome measures

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

EQUIPD-Pilot Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Coaching and Decision AidExperimental Treatment1 Intervention

Individual coaching sessions and Decision Aid

Group II: ControlActive Control1 Intervention

Wait-list control group

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Indiana UniversityLead Sponsor

980 Previous Clinical Trials

983,131 Total Patients Enrolled

1 Trials studying Health Equity

1,463 Patients Enrolled for Health Equity

National Institute of Nursing Research (NINR)NIH

579 Previous Clinical Trials

10,376,352 Total Patients Enrolled

Marianne Matthias, PhDPrincipal InvestigatorIndiana University

Media Library

Coaching and Decision Aid Clinical Trial Eligibility Overview. Trial Name: NCT05695209 — N/A

Health Equity Research Study Groups: Coaching and Decision Aid, Control

Health Equity Clinical Trial 2023: Coaching and Decision Aid Highlights & Side Effects. Trial Name: NCT05695209 — N/A

Coaching and Decision Aid 2023 Treatment Timeline for Medical Study. Trial Name: NCT05695209 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has enrollment for this research experiment begun?

"Based on the information published in clinicaltrials.gov, this medical experiment is not currently recruiting test subjects. Initially posted on April 1st 2023 and last edited twenty days ago, there are presently no openings for volunteers; however, 1650 other trials have available slots right now."

Answered by AI

What is the ultimate goal of this medical experiment?

"The primary goal of this trial, which will follow progress over a 6-month period, is to observe the changes from baseline in Brief Pain Inventory (BPI) Interference Scale at 3 months. Secondary objectives include assessing variations from baseline for Brief Pain Inventory (BPI) Intensity Scale at 3 months and Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Short Form scores over both 3 month and 6 month intervals."

Answered by AI