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Moderators and Mediators (M & M Trial) of Psychosocial Treatments of Chronic Pain
NCT06044649 · View on ClinicalTrials.gov ↗
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 |
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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. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 460 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Rush University Medical Center, which has 168 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06044649 reports 2 study locations spanning 2 distinct geographic areas — top geographies include Illinois, Michigan. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06044649?
This trial is sponsored by Rush University Medical Center, which has 168 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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