Comparative Mechanisms (Moderators, Mediators) of Psychosocial Treatments of Chronic Pain

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Behavioral, Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Illinois
Rush University Medical Center
RECRUITING
Chicago
Michigan
Wayne State University
RECRUITING
Detroit
Contact Information
Primary
John W Burns, PhD
john_burns@rush.edu
312-942-0379
Backup
Mark A Lumley, PhD
mlumley@wayne.edu
313-577-2247
Time Frame
Start Date: 2023-11-15
Estimated Completion Date: 2027-03-30
Participants
Target number of participants: 460
Treatments
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
Related Therapeutic Areas
Sponsors
Leads: Rush University Medical Center
Collaborators: Wayne State University

This content was sourced from clinicaltrials.gov