NCT06044649

Moderators and Mediators (M & M Trial) of Psychosocial Treatments of Chronic Pain

Recruiting now NA Last updated 25 April 2025

What this trial tests

NA trial testing Cognitive Behavioral Therapy in Chronic Pain in 460 participants. Currently enrolling.

Timeline

15 November 2023

Primary endpoint
30 September 2026

30 March 2027

Quick facts

Lead sponsor	Rush University Medical Center
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	460
Start date	15 November 2023
Primary completion	30 September 2026
Estimated completion	30 March 2027
Sites	2 locations across United States

Drugs / interventions tested

• Cognitive Behavioral Therapy
• Acceptance and Commitment Therapy
• Emotional Awareness and Expression Therapy
• Treatment as Usual

Conditions studied

• Chronic Pain — all drugs for Chronic Pain →
• Neck Pain — all drugs for Neck Pain →
• Back Pain — all drugs for Back Pain →

Sponsor

Rush University Medical Center

Who can join

18 and older, any sex, with Chronic Pain or Neck Pain. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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 the most effective treatment mechanisms and by informing patient-treatment matches that can optimize treatment effects.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Comparative main effects, mediators, and moderators of cognitive behavioral therapy, acceptance and commitment therapy, and emotional awareness and expression therapy for chronic spinal pain: Randomized controlled trial rationale and protocol.
   Burns JW, Lumley MA, Vowles KE, Jensen MP, et al · · 2025 · cited 1× · PMID 39881888 · DOI 10.1016/j.conctc.2025.101428