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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

460 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-15

Study Completion Date

2027-03-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Chronic Pain Neck Pain Back Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Masking of research staff and participants until baseline assessment is completed. Masking of research staff who interact with patients for outcome assessments.

Study Groups

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Cognitive Behavioral Therapy

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

Group Type EXPERIMENTAL

Cognitive Behavioral Therapy

Intervention Type BEHAVIORAL

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

Acceptance and Commitment Therapy

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

Group Type EXPERIMENTAL

Acceptance and Commitment Therapy

Intervention Type 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.

Emotional Awareness and Expression Therapy

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

Group Type EXPERIMENTAL

Emotional Awareness and Expression Therapy

Intervention Type 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.

Treatment As Usual

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

Group Type OTHER

Treatment as Usual

Intervention Type OTHER

Participants assigned to TAU will not receive any additional psychosocial treatment beyond the other treatments they were receiving before enrolling in this study.

Interventions

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Cognitive Behavioral Therapy

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

Intervention Type BEHAVIORAL

Acceptance and Commitment Therapy

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.

Intervention Type BEHAVIORAL

Emotional Awareness and Expression Therapy

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.

Intervention Type BEHAVIORAL

Treatment as Usual

Participants assigned to TAU will not receive any additional psychosocial treatment beyond the other treatments they were receiving before enrolling in this study.

Intervention Type OTHER

Other Intervention Names

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CBT for chronic pain ACT for chronic pain EAET for chronic pain TAU

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No