Moderators and Mediators (M & M Trial) of Psychosocial Treatments of Chronic Pain
Comparative Mechanisms (Moderators, Mediators) of Psychosocial Treatments of Chronic Pain
Rush University Medical Center
460 participants
Nov 15, 2023
INTERVENTIONAL
Conditions
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 the most effective treatment mechanisms and by informing patient-treatment matches that can optimize treatment effects.
Eligibility
Inclusion Criteria11
- 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 Criteria18
- 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)
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Interventions
CBT endorses a pain management model and teaches people skills to cope with chronic pain.
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.
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.
Participants assigned to TAU will not receive any additional psychosocial treatment beyond the other treatments they were receiving before enrolling in this study.
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06044649