Official Title
Comparative Mechanisms (Moderators, Mediators) of Psychosocial Treatments of Chronic Pain
Brief Summary

Chronic musculoskeletal pain (CP) is a major public health concern. Psychosocialtreatments have been shown to be efficacious when compared to largely inert controlconditions, but they are characterized by modest effects on primary outcomes. Onestrategy to boost efficacy is to increase our understanding of treatment mediators.Studies of mediators that directly compare different treatments with each other areneeded to determine which mediators are treatment-specific, which are shared acrosstreatments, and which contribute the most to clinical outcomes. Another strategy is toidentify the patient characteristics that moderate treatment responses. Research isneeded that is guided by theoretical models and that tests moderators across multipletreatments. Identifying subgroups of patients more likely to respond to one or anothertreatment can advance precision medicine by informing a priori patient-treatment matchesthat can optimize treatment effects. To accomplish these goals, the authors will conducta randomized clinical trial to compare the mediators and moderators of the clinicaleffects 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 potentialmediators and moderators, 460 participants will be randomized to CBT, ACT, EAET, ortreatment-as-usual control (TAU). The three treatments will be conducted as individualtherapy provided weekly for 8 weeks via telehealth. The researchers will conduct weeklyassessments of both potential mediators and outcomes, as well as post-treatment and6-month follow-up assessments. The goal of the study is to identify the most powerfultreatment mechanisms - specific and shared -- and reveal for whom the mediator-outcomepathways are strongest.This project can increase the effects of our psychosocial chronicpain treatments by identifying the most effective treatment mechanisms and by informingpatient-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.

Recruiting
Chronic Pain
Neck Pain
Back Pain

Behavioral: Cognitive Behavioral Therapy

CBT endorses a pain management model and teaches people skills to cope with chronic pain.
Other Name: CBT for chronic pain

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.
Other Name: ACT for chronic pain

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.
Other Name: EAET for chronic pain

Other: 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.
Other Name: TAU

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)

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
United States
Locations

Rush University Medical Center
Chicago, Illinois, United States

Wayne State University
Detroit, Michigan, United States

Contacts

John W Burns, PhD
312-942-0379
john_burns@rush.edu

Mark A Lumley, PhD
313-577-2247
mlumley@wayne.edu

John W Burns, PhD, Principal Investigator
Rush University Medical Center

Wayne State University
NCT Number
MeSH Terms
Chronic Pain
Neck Pain