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

Chronic Pain Clinical Trial

Official title:

Comparative Mechanisms (Moderators, Mediators) of Psychosocial Treatments of Chronic Pain

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06044649
• Other study ID #: 22010705
• Status: Recruiting
• Phase: N/A
• Start date: November 15, 2023
• Est. completion date: March 30, 2027

Study information

• Verified date: November 2023
• Source: Rush University Medical Center
• Contact: John W Burns, PhD
• Phone: 312-942-0379
• Email: john_burns[@]rush.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 460
• Est. completion date: March 30, 2027
• Est. primary completion date: September 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 (and in a state that has psychology license agreement: PSYPACT)

• 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)

Related Conditions & MeSH terms

• Back Pain
• Chronic Pain
• Neck Pain

Intervention

Behavioral:
• Cognitive Behavioral Therapy
CBT endorses a pain management model and teaches people skills to cope with chronic pain.
• 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.
• 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:
• 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.

Locations

Country	Name	City	State
United States	Rush University Medical Center	Chicago	Illinois
United States	Wayne State University	Detroit	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
Rush University Medical Center	Wayne State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Pain Catastrophizing Scale (PCS)-short form	Potential Mediator; 6-item measure of pain catastrophizing (range 0 to 4; higher scores = higher pain catastrophizing)	Baseline to post-treatment and 6-month follow-up, and weekly during treatment
Other	Pain Self-Efficacy Questionnaire (PSEQ) - Short Form	Potential Mediator; 4-item measure of current pain self-efficacy (range 0 to 6; higher scores = higher pain self-efficacy)	Baseline to post-treatment and 6-month follow-up, and weekly during treatment
Other	Survey of Pain Attitudes (SOPA): Pain Control, Disability, Harm, Emotion subscales	Potential Mediator; 4, 2-item measures of current pain attitudes (range 0 to 4; higher scores = more of that construct)	Baseline to post-treatment and 6-month follow-up, and weekly during treatment
Other	Behavioral Activation for Depression (BADS) - Short Form	Potential Mediator; 9-item measure of behavioral activation for depression in the past week (range 0 to 6; higher scores = higher behavioral activation)	Baseline to post-treatment and 6-month follow-up, and weekly during treatment
Other	Self-Compassion Scale (SCS) - Short Form	Potential Mediator; 12-item measure of situational self-compassion (range 1 to 5; higher scores = less self-compassion)	Baseline to post-treatment and 6-month follow-up, and weekly during treatment
Other	Chronic Pain Acceptance Questionnaire (CPAQ)	Potential Mediator; 8-item measure of current chronic pain acceptance (range 0 to 6; higher scores = more chronic pain acceptance)	Baseline to post-treatment and 6-month follow-up, and weekly during treatment
Other	Chronic Pain Values Inventory (CPVI)	Potential Mediator; 6-item measure of current values (checklist responses)	Baseline to post-treatment and 6-month follow-up, and weekly during treatment
Other	Emotional Approach Coping Scale (EAC) - Short Form	Potential Mediator; 4-item measure of emotional approach coping (range 1 to 4; higher scores = higher emotional approach coping)	Baseline to post-treatment and 6-month follow-up, and weekly during treatment
Other	Emotional Breakthrough Inventory (EBI)	Potential Mediator; 6-item measure of emotional breakthroughs in the past week (range 0 to 6; higher scores = more emotional breakthroughs)	Baseline to post-treatment and 6-month follow-up, and weekly during treatment
Other	Psychological Insight Questionnaire (PIQ)	Potential Mediator; 6-item measure of psychological insight in the past week (range 0 to 5; higher scores = more psychological insight)	Baseline to post-treatment and 6-month follow-up, and weekly during treatment
Other	Brain and Psychological Attributions for Pain	Potential Mediator; 9-item measure of current belief of brain and psychological attributions for pain (range 0 to 4; higher scores = higher belief in brain and psychological attributions for pain)	Baseline to post-treatment and 6-month follow-up, and weekly during treatment
Other	Pain Anxiety Symptom Scale (PASS)	Potential Mediator; 4-item measure of current pain anxiety symptoms (range 0 to 5; higher scores = worse pain anxiety symptoms)	Baseline to post-treatment and 6-month follow-up, and weekly during treatment
Other	Adverse Events	Potential Mediator; 2-item measure of adverse events in the past week and past 6 months (checklist responses)	Weekly during treatment to post-treatment and 6-month follow-up
Other	Working Alliance Inventory (WAI) - Patient	Potential Mediator; 6-item measure of current working alliance (range 0 to 5; higher scores = better working alliance)	Weekly during treatment to post-treatment for three treatment arms only
Other	Working Alliance Inventory (WAI) - Therapist - Short Form	Potential Mediator; 6-item measure of current working alliance (range 0 to 5; higher scores = better working alliance)	Weekly during treatment to post-treatment for three treatment arms only
Other	Therapist Checklist of Patient Engagement and Homework	Potential Mediator; 4-item measure on current patient engagement (range 0 to 8; higher scores = more patient engagement)	Weekly during treatment to post-treatment for three treatment arms only
Other	Treatment Expectancy and Credibility Questionnaire	Potential Mediator; 8-item measure on current treatment expectancy and credibility (range 0 to 10; higher scores = better treatment expectancy)	Weekly during treatment to post-treatment for three treatment arms only
Primary	Brief Pain Inventory (BPI) - Pain Severity	4-item measure of pain severity over past week (range 0 to 10; higher scores = worse pain severity)	Baseline to post-treatment and 6-month follow-up, and weekly during treatment
Primary	Patient-Reported Outcome Measurement Information System (PROMIS) - Pain Interference - Short Form 8a	8-item measure of pain interference over past week (range1 to 5; higher scores = more pain interference)	Baseline to post-treatment and 6-month follow-up, and weekly during treatment
Secondary	Patient Global Impression of Change	1-item measure of overall health change since the start of the study (range 1 to 7; higher scores = more health improvement)	Weekly during treatment to post-treatment and 6-month follow-up
Secondary	Patient-Reported Outcome Measurement Information System (PROMIS) - Physical Function - Short Form 10a	4-item measure of current physical function (range 1 to 5; higher scores = poorer physical function)	Baseline to post-treatment and 6-month follow-up, and weekly during treatment
Secondary	Patient-Reported Outcome Measurement Information System (PROMIS) - Emotional Distress - Anxiety - Short Form	4-item measure of anxiety symptoms in the past week (range 1 to 5; higher scores = more anxiety symptoms)	Baseline to post-treatment and 6-month follow-up, and weekly during treatment
Secondary	Patient-Reported Outcome Measurement Information System (PROMIS) - Emotional Distress - Depression - Short Form	4-item measure of depression symptoms in the past week (range 1 to 5; higher scores = more depression symptoms)	Baseline to post-treatment and 6-month follow-up, and weekly during treatment
Secondary	Patient Health Questionnaire - Depression	8-item measure of depression symptoms in the past week (range 0 to 3; higher scores = more depression symptoms)	Baseline to post-treatment and 6-month follow-up, and weekly during treatment
Secondary	Patient-Reported Outcome Measurement Information System (PROMIS) - Fatigue - Short Form	4-item measure of fatigue in the past week (range 1 to 5; higher scores = more fatigue)	Baseline to post-treatment and 6-month follow-up, and weekly during treatment
Secondary	Patient-Reported Outcome Measurement Information System (PROMIS) - Sleep Disturbance - Short Form	4-item measure of sleep disturbance in the past week (range 1 to 5; higher scores = more sleep disturbance)	Baseline to post-treatment and 6-month follow-up, and weekly during treatment
Secondary	Patient-Reported Outcome Measurement Information System (PROMIS) - Emotional Distress - Anger - Short Form 5a	5-item measure of anger in the past week (range 1 to 5; higher scores = more anger)	Baseline to post-treatment and 6-month follow-up, and weekly during treatment
Secondary	Positive and Negative Affect Schedule (PANAS) - Positive Affect - Short Form	5-item measure of positive affect in the past week (range 1 to 5; higher scores = more positive affectivity)	Baseline to post-treatment and 6-month follow-up, and weekly during treatment
Secondary	Posttraumatic Stress Disorder Checklist (PCL) - Short Form	5-item measure of trauma symptoms in the past week (range 1 to 4; higher scores = worse PTSD symptoms)	Baseline to post-treatment and 6-month follow-up, and weekly during treatment
Secondary	Pain Stages of Change Questionnaire (PSOCQ): Preparation and action	13-item measure on current readiness to adopt self-management for pain, Preparation and Action items only (range 1 to 5; higher scores = more ready to change)	Baseline to post-treatment and 6-month follow-up, and weekly during treatment
Secondary	Opioid Use	1-item measure on opioid use in past 7 days (range 1 to 7; higher scores = more days)	Baseline to post-treatment and 6-month follow-up, and weekly during treatment
Secondary	Employment	3-item measure on current employment (options for current status and qualitative responses)	Baseline to post-treatment and 6-month follow-up
Secondary	Post-Treatment Satisfaction Questionnaire	8-item measure on patient post-treatment satisfaction (range 1 to 10; higher scores = more satisfied - also included qualitative responses)	Post-Treatment to 6-Month Follow-Up
Secondary	Levels of Emotional Awareness Scale (LEAS) - Forms A and B	10-item measure of current emotional awareness (includes qualitative responses); responses coded for levels of emotional awareness; higher = greater awareness; Form A baseline and Form B at post-treatment	Baseline
Secondary	Other Pain Treatments and Health Care Use	2-item measure of health care currently, the past 6 months, and the past 4 weeks (2 items with yes/no responses and remaining range 0 to 4; higher scores = more treatment)	Baseline to post-treatment and 6-month follow-up
Secondary	Inventory of Interpersonal Problems (IIP)	32-item measure of current interpersonal problems (range 0 to 4; higher scores = more interpersonal problems)	Baseline to post-treatment and 6-month follow-up
Secondary	American College of Rheumatology (ACR) Fibromyalgia Diagnostic Criteria - 2011	8-item measure on fibromyalgia symptoms in the past week (items with yes/no responses, a checklist, and remaining range 0 to 3; higher scores = worse fibromyalgia symptoms)	Baseline to post-treatment and 6-month follow-up
Secondary	Psychological Flexibility Scale (PSYFlex)	6-item measure of psychological flexibility in the past week (range 0 to 5; higher scores = higher psychological flexibility)	Baseline to post-treatment and 6-month follow-up
Secondary	The Tobacco, Alcohol, Prescription medications, and other Substance (TAPS) Tool - Part II	9-item measure on substance use in the past week (yes/no responses); higher scores = more use	Baseline to post-treatment and 6-month follow-up
Secondary	Posttraumatic Stress Disorder Checklist (PCL)	20-item measure of PTSD symptoms in the past month (range 0 to 4; higher scores = worse PTSD symptoms)	Baseline to post-treatment and 6-month follow-up