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

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Rush University Medical Center
Study ID
NCT06044649
Status
Recruiting
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Conditions

  • Back Pain
  • Chronic Pain
  • Neck Pain

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Cognitive Behavioral Therapy — BEHAVIORAL
    CBT endorses a pain management model and teaches people skills to cope with chronic pain.
  • Acceptance and Commitment Therapy — BEHAVIORAL
    ACT is based on an acceptance model that seeks to decrease pain avoidance behaviors and enhance engagement in valued, adaptive activities that contribute to fewer pain-related restrictions in functioning.
  • Emotional Awareness and Expression Therapy — BEHAVIORAL
    EAET advocates a pain treatment model in which pain can be substantially reduced by helping people learn that their pain is brain-based and can be substantially reduced or eliminated by decreasing fear of pain and of various emotional/interpersonal problems.
  • Treatment as Usual — OTHER
    Participants assigned to TAU will not receive any additional psychosocial treatment beyond the other treatments they were receiving before enrolling in this study.

Study Details

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.

Key Dates

Start date
Nov 15, 2023
Status verified
Apr 2025
Primary completion
Sep 30, 2026
Completion
Mar 30, 2027

Study Design

Enrollment
460 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cognitive Behavioral Therapy
    8-session, individual, Cognitive Behavioral Therapy delivered remotely by skilled CBT therapists
  • Experimental: Acceptance and Commitment Therapy
    8-session, individual, Acceptance and Commitment Therapy delivered remotely by skilled ACT therapists
  • Experimental: Emotional Awareness and Expression Therapy
    8-session, individual, Emotional Awareness and Expression Therapy delivered remotely by skilled EAET
  • Other: Treatment As Usual
    In this control condition, participants will engage in their usual care for neck/back pain with no additional experimental intervention

Primary Outcome Measure

Brief Pain Inventory (BPI) - Pain Severity [ Time Frame: Baseline to post-treatment and 6-month follow-up, and weekly during treatment ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Rush University Medical CenterChicagoIllinois60612
John W Burns, PhD
[email protected]
312-942-0379
Wayne State UniversityDetroitMichigan48202
Mark A. Lumley, PhD
[email protected]
313-577-2247

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By research site
Rush University Medical Center· Chicago, ILWayne State University· Detroit, MI

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