Moderators and Mediators (M & M Trial) of Psychosocial Treatments of Chronic Pain
Launched by RUSH UNIVERSITY MEDICAL CENTER · Sep 13, 2023
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
The M & M Trial is studying how different types of psychological treatments can help adults with chronic pain in their neck or back. Chronic pain is when someone has ongoing pain for more than three months, and this study aims to understand which treatment works best for which patients. The researchers will compare three types of therapy: Cognitive-Behavioral Therapy (CBT), Acceptance and Commitment Therapy (ACT), and Emotional Awareness and Expression Therapy (EAET). Participants will be randomly assigned to one of these treatments or to a control group that receives usual care. The therapy sessions will be done weekly over eight weeks through telehealth, making it easier for participants to join from home.
To be eligible for this trial, participants should be at least 18 years old, live in the United States, and have significant neck or back pain that interferes with their daily life. They also need to have access to a computer or tablet and the internet. However, individuals with certain medical and psychological conditions, like severe depression or recent major life stressors, may not qualify. Throughout the study, participants can expect to complete assessments to track their pain, emotional responses, and overall well-being both during and after the treatment period. This research hopes to identify effective treatment strategies that can improve pain management for different individuals.
Gender
ALL
Eligibility criteria
- 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)
About Rush University Medical Center
Rush University Medical Center is a leading academic medical institution located in Chicago, Illinois, dedicated to advancing healthcare through innovative research and clinical trials. As a sponsor of numerous clinical studies, Rush focuses on translating scientific discoveries into effective treatments and improving patient outcomes across a variety of medical disciplines. With a commitment to excellence in patient care, education, and research, Rush leverages its state-of-the-art facilities and a robust network of specialists to conduct comprehensive trials that adhere to the highest ethical and regulatory standards. Through collaboration with a diverse patient population, Rush aims to enhance the understanding of diseases and develop novel therapeutic strategies.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Chicago, Illinois, United States
Detroit, Michigan, United States
Patients applied
Trial Officials
John W Burns, PhD
Principal Investigator
Rush University Medical Center
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported