Moderators and Mediators (M & M Trial) of Psychosocial Treatments of Chronic Pain
Purpose
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
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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)
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- 4-arm parallel randomized clinical trial comparing three therapies with each other and with a treatment as usual control
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
- Masking Description
- Masking of research staff and participants until baseline assessment is completed. Masking of research staff who interact with patients for outcome assessments.
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
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 |
|
Recruiting Locations
Chicago 4887398, Illinois 4896861 60612
Detroit 4990729, Michigan 5001836 48202
More Details
- Status
- Recruiting
- Sponsor
- Rush University Medical Center
Detailed Description
Chronic musculoskeletal pain (CP) is a major public health concern. A number of psychosocial treatments have emerged in recent decades to help address this problem. These interventions have been shown to be efficacious when compared to largely inert control conditions; however, recent meta-analyses indicate that most of these treatments are characterized by modest effects on primary outcomes. This is a critical shortcoming of these otherwise promising approaches. Rather than attempting to boost efficacy only by developing new and hopefully more powerful interventions, we can also look within our already proven treatments for ways to enhance the magnitude of treatment effects. One strategy 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. The findings from such research could be used to inform adaptations to existing treatment that enhance their benefits. A second strategy for increasing the beneficial effects of existing treatments 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, we 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 we will randomize 460 participants 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. We will conduct weekly assessments of both potential mediators and outcomes, as well as post-treatment and 6-month follow-up assessments. In addition to comparing the three treatments to each other (and TAU) for overall efficacy, we focus on two specific aims: Aim 1 is to identify mediators that are specific to treatments and those that are shared across treatments. Aim 2 is to identify baseline moderators of specific treatments and general predictors across treatments. This project can increase the effects of our psychosocial chronic pain treatments by identifying the most powerful treatment mechanisms - specific and shared -- and revealing for whom the mediator-outcome pathways are strongest. Via increased understanding of mediator and moderators, more effective pain treatment approaches can be developed, tested, and implemented.