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

NCT06044649 | Recruiting

• 1 other identifier: 22010705
• Study Type: interventional
• Target: 460
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Chronic Pain; Neck Pain; Back Pain

Outcome Measures

Primary Outcomes (2)

• Brief Pain Inventory (BPI) - Pain Severity

  4-item measure of pain severity over past week (range 0 to 10; higher scores = worse pain severity)

  Baseline to post-treatment and 6-month follow-up, and weekly during treatment

• Patient-Reported Outcome Measurement Information System (PROMIS) - Pain Interference - Short Form 8a

  8-item measure of pain interference over past week (range1 to 5; higher scores = more pain interference)

  Baseline to post-treatment and 6-month follow-up, and weekly during treatment

Secondary Outcomes (21)

• Patient Global Impression of Change

  Weekly during treatment to post-treatment and 6-month follow-up

• Patient-Reported Outcome Measurement Information System (PROMIS) - Physical Function - Short Form 10a

  Baseline to post-treatment and 6-month follow-up, and weekly during treatment

• Patient-Reported Outcome Measurement Information System (PROMIS) - Emotional Distress - Anxiety - Short Form

  Baseline to post-treatment and 6-month follow-up, and weekly during treatment

• Patient-Reported Outcome Measurement Information System (PROMIS) - Emotional Distress - Depression - Short Form

  Baseline to post-treatment and 6-month follow-up, and weekly during treatment

• Patient Health Questionnaire - Depression

  Baseline to post-treatment and 6-month follow-up, and weekly during treatment

Other Outcomes (17)

• Pain Catastrophizing Scale (PCS)-short form

  Baseline to post-treatment and 6-month follow-up, and weekly during treatment

• Pain Self-Efficacy Questionnaire (PSEQ) - Short Form

  Baseline to post-treatment and 6-month follow-up, and weekly during treatment

• Survey of Pain Attitudes (SOPA): Pain Control, Disability, Harm, Emotion subscales

  Baseline to post-treatment and 6-month follow-up, and weekly during treatment

Study Arms (4)

Cognitive Behavioral Therapy

EXPERIMENTAL

8-session, individual, Cognitive Behavioral Therapy delivered remotely by skilled CBT therapists

Behavioral: Cognitive Behavioral Therapy

Acceptance and Commitment Therapy

EXPERIMENTAL

8-session, individual, Acceptance and Commitment Therapy delivered remotely by skilled ACT therapists

Behavioral: Acceptance and Commitment Therapy

Emotional Awareness and Expression Therapy

EXPERIMENTAL

8-session, individual, Emotional Awareness and Expression Therapy delivered remotely by skilled EAET

Behavioral: Emotional Awareness and Expression Therapy

Treatment As Usual

OTHER

In this control condition, participants will engage in their usual care for neck/back pain with no additional experimental intervention

Other: Treatment as Usual

Interventions

Cognitive Behavioral Therapy BEHAVIORAL

CBT endorses a pain management model and teaches people skills to cope with chronic pain.

Also known as: CBT for chronic pain

Cognitive Behavioral Therapy

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.

Also known as: ACT for chronic pain

Acceptance and Commitment Therapy

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.

Also known as: EAET for chronic pain

Emotional Awareness and Expression Therapy

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.

Also known as: TAU

Treatment As Usual

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rush University Medical Center: lead
• Wayne State University: collaborator

Study Sites (2)

Rush University Medical Center

Chicago, Illinois, 60612, United States

RECRUITING

Wayne State University

Detroit, Michigan, 48202, United States

RECRUITING

MeSH Terms

Conditions

Chronic Pain; Neck Pain; Back Pain

Interventions

Cognitive Behavioral Therapy; Acceptance and Commitment Therapy; Therapeutics

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• John W Burns, PhD

  Rush University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

John W Burns, PhD

CONTACT

312-942-0379; john_burns@rush.edu

Mark A Lumley, PhD

CONTACT

313-577-2247; mlumley@wayne.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Masking of research staff and participants until baseline assessment is completed. Masking of research staff who interact with patients for outcome assessments.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 4-arm parallel randomized clinical trial comparing three therapies with each other and with a treatment as usual control

Study Record Dates

• First Submitted: September 11, 2023
• First Posted: September 21, 2023
• Study Start: November 15, 2023
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): March 30, 2027
• Last Updated: April 25, 2025

Record last verified: 2025-04

Locations

US (2)