Actively Recruiting
Moderators and Mediators (M & M Trial) of Psychosocial Treatments of Chronic Pain
Led by Rush University Medical Center · Updated on 2025-04-25
460
Participants Needed
2
Research Sites
175 weeks
Total Duration
On this page
Sponsors
R
Rush University Medical Center
Lead Sponsor
W
Wayne State University
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Moderators and Mediators (M & M Trial) of Psychosocial Treatments of Chronic Pain
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Back or neck is the primary pain location (pain in back/neck greater than leg pain)
- Pain lasting at least 3 months and occurring on 4 or more days per week over the past 6 months
- Pain intensity of 3 or higher on a 0 to 10 scale in the last week
- Pain interference of 3 or higher on a 0 to 10 scale in the last week
- At least 18 years old
- Lives in the United States
- Fluent in English
- Has personal computer or tablet and internet access
- Able to attend weekly therapy sessions
- Willing to be randomly assigned to a treatment group
- Seeking improvement in pain through psychological therapy
You will not qualify if you...
- Treatment for or experience of complex regional pain syndrome in past 2 years
- Treatment for or experience of epilepsy or seizure disorder in past 2 years
- Treatment for or experience of autoimmune disease in past 2 years
- Treatment for or experience of liver disease in past 2 years
- Treatment for or experience of cancer in past 2 years
- Treatment for or experience of heart disease in past 2 years
- Substance dependence or use disorder in past 2 years
- Schizophrenia or other psychotic disorder in past 2 years
- Bipolar disorder in past 2 years
- Obsessive-compulsive disorder in past 2 years
- Borderline personality disorder in past 2 years
- Suicide attempt, intention, or impulse in past 2 years
- Major medical procedure planned within next 9 months
- Applied for or involved in litigation for pain-related disability or worker's compensation in past year
- Experienced major life event or stressor in past 6 months
- Cognitive impairment with screener score of 4 or less
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Rush University Medical Center
Chicago, Illinois, United States, 60612
Actively Recruiting
2
Wayne State University
Detroit, Michigan, United States, 48202
Actively Recruiting
Research Team
J
John W Burns, PhD
CONTACT
M
Mark A Lumley, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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