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NCT06044649 · ClinicalTrials.gov registry record · NA
Moderators and Mediators (M & M Trial) of Psychosocial Treatments of Chronic Pain
A NA study of Chronic Pain and Back Pain, sponsored by Rush University Medical Center.
- Recruiting
- Registry status
- NA
- Development phase
- 460
- Enrollment target
- 2
- Study locations
NCT06044649 is a NA study of Chronic Pain and Back Pain that is actively recruiting participants, run by Rush University Medical Center. The registered enrollment target is 460 participants, below the 771-participant average among 301 other Chronic Pain trials with a reported enrollment target (40% lower). The trial reports 2 study locations across 2 states.
The verdict
NCT06044649, a NA study of Chronic Pain and Back Pain, is actively recruiting participants, sponsored by Rush University Medical Center.
- RECRUITING
- Registry status
- NA
- Development phase
- 460 participants
- Enrollment target
- 2
- Study locations
Study Summary
Chronic musculoskeletal pain (CP) is a major public health concern. Psychosocial treatments have been shown to be efficacious when compared to largely inert control conditions, but they are characterized by modest effects on primary outcomes. One strategy to boost efficacy is to increase our understanding of treatment mediators. Studies of mediators that directly compare different treatments with each other are needed to determine which mediators are treatment-specific, which are shared across treatments, and which contribute the most to clinical outcomes. Another strategy is to identify the patient characteristics that moderate treatment responses. Research is needed that is guided by theoretical models and that tests moderators across multiple treatments. Identifying subgroups of patients more likely to respond to one or another treatment can advance precision medicine by informing a priori patient-treatment matches that can optimize treatment effects. To accomplish these goals, the authors will conduct a randomized clinical trial to compare the mediators and moderators of the clinical effects of Cognitive-Behavioral Therapy (CBT), Acceptance and Commitment Therapy (ACT), and Emotional Awareness and Expression Therapy (EAET) on adults with chronic spinal (axial) pain. Following baseline assessment of outcome variables as well as potential mediators and moderators, 460 participants will be randomized to CBT, ACT, EAET, or treatment-as-usual control (TAU). The three treatments will be conducted as individual therapy provided weekly for 8 weeks via telehealth. The researchers will conduct weekly assessments of both potential mediators and outcomes, as well as post-treatment and 6-month follow-up assessments. The goal of the study is to identify the most powerful treatment mechanisms - specific and shared -- and reveal for whom the mediator-outcome pathways are strongest.This project can increase the effects of our psychosocial chronic pain treatments by identifying t
Conditions Studied
Interventions
- BEHAVIORAL Emotional Awareness and Expression Therapy
- OTHER Treatment as Usual
- BEHAVIORAL Cognitive Behavioral Therapy
- BEHAVIORAL Acceptance and Commitment Therapy
Study Locations (2)
Illinois
- Rush University Medical Center - Chicago
Michigan
- Wayne State University - Detroit
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 460 participants |
| Start Date | 2023-11-15 |
| Est. Completion | 2027-03-30 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06044649
The ClinicalTrials.gov registry entry for NCT06044649 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 460 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 771-participant average among 301 other Chronic Pain trials with a reported enrollment target (40% lower). The listed sponsor is Rush University Medical Center, which has 320 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Chronic Pain appearing as the primary indexed condition, and to 4 interventions - of which Emotional Awareness and Expression Therapy is the first listed.
NCT06044649 reports 2 study locations spanning 2 distinct geographic areas - top geographies include Illinois, Michigan.
Frequently Asked Questions
What is clinical trial NCT06044649 about?
NCT06044649 is a clinical study titled "Moderators and Mediators (M & M Trial) of Psychosocial Treatments of Chronic Pain". Chronic musculoskeletal pain (CP) is a major public health concern. Psychosocial treatments have been shown to be efficacious when compared to largely inert control conditions, but they are characterized by modest effects on primary outcomes. One strategy to boost efficacy is to increase our underst...
What is the current status of trial NCT06044649?
This trial is currently recruiting. It is a NA study. The enrollment target is 460 participants. The study started on 2023-11-15. Estimated completion is 2027-03-30.
What conditions does trial NCT06044649 study?
This clinical trial studies the following conditions: Chronic Pain, Back Pain, Neck Pain.
What interventions are being tested in trial NCT06044649?
The interventions under investigation include: Emotional Awareness and Expression Therapy (BEHAVIORAL), Treatment as Usual (OTHER), Cognitive Behavioral Therapy (BEHAVIORAL), Acceptance and Commitment Therapy (BEHAVIORAL).
Who is sponsoring clinical trial NCT06044649?
This trial is sponsored by Rush University Medical Center, which has 320 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06044649 being conducted?
This trial has 2 study locations across Illinois, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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