Moderators and Mediators (M & M Trial) of Psychosocial Treatments of Chronic Pain
Active, not recruitingNot applicableNCT06044649
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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…
Study details
- Official title
- Comparative Mechanisms (Moderators, Mediators) of Psychosocial Treatments of Chronic Pain
- Conditions
- Interventions
- Sponsor
- Rush University Medical Center
- Collaborators
- Wayne State University
- Start date
- 2023-11-15
- Primary completion
- 2026-08-30
- Sex
- All
- Age range
- from 18 Years
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 2
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * Back/neck is primary pain location (e.g., back/neck pain greater than leg pain) * Pain for at least 3 months and experienced 4 or more days/week for the past 6 months * Pain intensity last week is \>= 3 (0 to 10 rating scale) * Pain interference last week is \>= 3 (0 to 10 rating scale) * At least age 18 * Lives in United States * Fluent in English * Has personal computer/tablet and internet access * Able to attend weekly sessions * Willing to be randomized * Seeking to improve their pain-related status via a psychological therapy Exclusion Criteria: Past 2 years (treated for or having experienced): * Complex regional pain syndrome * Epilepsy/seizure disorder * Autoimmune disease * Liver disease * Cancer * Heart disease * Substance dependence or use disorder * Schizophrenia or other psychotic disorder * Bipolar disorder * Obsessive-compulsive disorder * Borderline personality disorder * Suicide attempt or suicide intention or impulse Also: * Major medical procedure scheduled within next 9 months * Applied for/ litigating for pain-related disability/worker's compensation (past year). * Major life event/stressor in past 6 months * Cognitive impairment (screener score \<=4)
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT06044649