Clinical trial NCT06044649: Moderators and Mediators (M & M Trial) of Psychosocial Treatments of Chronic Pain
Official title: Comparative Mechanisms (Moderators, Mediators) of Psychosocial Treatments of Chronic Pain
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Pain
Neck Pain
Back Pain
Lead sponsor: Rush University Medical Center
Sponsor class: OTHER
Collaborators: name: Wayne State University
First posted: 2023-09-21
Enrollment: 460
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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

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.

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.

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)

Primary outcomes:
measure: Brief Pain Inventory (BPI) - Pain Severity
timeFrame: Baseline to post-treatment and 6-month follow-up, and weekly during treatment
measure: Patient-Reported Outcome Measurement Information System (PROMIS) - Pain Interference - Short Form 8a
timeFrame: Baseline to post-treatment and 6-month follow-up, and weekly during treatment
Secondary outcomes:
measure: Patient Global Impression of Change
timeFrame: Weekly during treatment to post-treatment and 6-month follow-up
measure: Patient-Reported Outcome Measurement Information System (PROMIS) - Physical Function - Short Form 10a
timeFrame: Baseline to post-treatment and 6-month follow-up, and weekly during treatment
measure: Patient-Reported Outcome Measurement Information System (PROMIS) - Emotional Distress - Anxiety - Short Form
timeFrame: Baseline to post-treatment and 6-month follow-up, and weekly during treatment
measure: Patient-Reported Outcome Measurement Information System (PROMIS) - Emotional Distress - Depression - Short Form
timeFrame: Baseline to post-treatment and 6-month follow-up, and weekly during treatment
measure: Patient Health Questionnaire - Depression
timeFrame: Baseline to post-treatment and 6-month follow-up, and weekly during treatment
measure: Patient-Reported Outcome Measurement Information System (PROMIS) - Fatigue - Short Form
timeFrame: Baseline to post-treatment and 6-month follow-up, and weekly during treatment
measure: Patient-Reported Outcome Measurement Information System (PROMIS) - Sleep Disturbance - Short Form
timeFrame: Baseline to post-treatment and 6-month follow-up, and weekly during treatment
measure: Patient-Reported Outcome Measurement Information System (PROMIS) - Emotional Distress - Anger - Short Form 5a
timeFrame: Baseline to post-treatment and 6-month follow-up, and weekly during treatment
measure: Positive and Negative Affect Schedule (PANAS) - Positive Affect - Short Form
timeFrame: Baseline to post-treatment and 6-month follow-up, and weekly during treatment
measure: Posttraumatic Stress Disorder Checklist (PCL) - Short Form
timeFrame: Baseline to post-treatment and 6-month follow-up, and weekly during treatment
measure: Pain Stages of Change Questionnaire (PSOCQ): Preparation and action
timeFrame: Baseline to post-treatment and 6-month follow-up, and weekly during treatment
measure: Opioid Use
timeFrame: Baseline to post-treatment and 6-month follow-up, and weekly during treatment
measure: Employment
timeFrame: Baseline to post-treatment and 6-month follow-up
measure: Post-Treatment Satisfaction Questionnaire
timeFrame: Post-Treatment to 6-Month Follow-Up
measure: Levels of Emotional Awareness Scale (LEAS) - Forms A and B
timeFrame: Baseline
measure: Other Pain Treatments and Health Care Use
timeFrame: Baseline to post-treatment and 6-month follow-up
measure: Inventory of Interpersonal Problems (IIP)
timeFrame: Baseline to post-treatment and 6-month follow-up
measure: American College of Rheumatology (ACR) Fibromyalgia Diagnostic Criteria - 2011
timeFrame: Baseline to post-treatment and 6-month follow-up
measure: Psychological Flexibility Scale (PSYFlex)
timeFrame: Baseline to post-treatment and 6-month follow-up
measure: The Tobacco, Alcohol, Prescription medications, and other Substance (TAPS) Tool - Part II
timeFrame: Baseline to post-treatment and 6-month follow-up
measure: Posttraumatic Stress Disorder Checklist (PCL)
timeFrame: Baseline to post-treatment and 6-month follow-up
Other outcomes:
measure: Pain Catastrophizing Scale (PCS)-short form
timeFrame: Baseline to post-treatment and 6-month follow-up, and weekly during treatment
measure: Pain Self-Efficacy Questionnaire (PSEQ) - Short Form
timeFrame: Baseline to post-treatment and 6-month follow-up, and weekly during treatment
measure: Survey of Pain Attitudes (SOPA): Pain Control, Disability, Harm, Emotion subscales
timeFrame: Baseline to post-treatment and 6-month follow-up, and weekly during treatment
measure: Behavioral Activation for Depression (BADS) - Short Form
timeFrame: Baseline to post-treatment and 6-month follow-up, and weekly during treatment
measure: Self-Compassion Scale (SCS) - Short Form
timeFrame: Baseline to post-treatment and 6-month follow-up, and weekly during treatment
measure: Chronic Pain Acceptance Questionnaire (CPAQ)
timeFrame: Baseline to post-treatment and 6-month follow-up, and weekly during treatment
measure: Chronic Pain Values Inventory (CPVI)
timeFrame: Baseline to post-treatment and 6-month follow-up, and weekly during treatment
measure: Emotional Approach Coping Scale (EAC) - Short Form
timeFrame: Baseline to post-treatment and 6-month follow-up, and weekly during treatment
measure: Emotional Breakthrough Inventory (EBI)
timeFrame: Baseline to post-treatment and 6-month follow-up, and weekly during treatment
measure: Psychological Insight Questionnaire (PIQ)
timeFrame: Baseline to post-treatment and 6-month follow-up, and weekly during treatment
measure: Brain and Psychological Attributions for Pain
timeFrame: Baseline to post-treatment and 6-month follow-up, and weekly during treatment
measure: Pain Anxiety Symptom Scale (PASS)
timeFrame: Baseline to post-treatment and 6-month follow-up, and weekly during treatment
measure: Adverse Events
timeFrame: Weekly during treatment to post-treatment and 6-month follow-up
measure: Working Alliance Inventory (WAI) - Patient
timeFrame: Weekly during treatment to post-treatment for three treatment arms only
measure: Working Alliance Inventory (WAI) - Therapist - Short Form
timeFrame: Weekly during treatment to post-treatment for three treatment arms only
measure: Therapist Checklist of Patient Engagement and Homework
timeFrame: Weekly during treatment to post-treatment for three treatment arms only
measure: Treatment Expectancy and Credibility Questionnaire
timeFrame: Weekly during treatment to post-treatment for three treatment arms only
Locations:
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Detroit
country: United States
facility: Wayne State University
state: Michigan
Study officials:
affiliation: Rush University Medical Center
name: John W Burns, PhD
role: PRINCIPAL_INVESTIGATOR
References: