460 Participants Needed

Psychosocial Treatments for Chronic Pain

Recruiting at 1 trial location
JB
MA
Overseen ByMark A Lumley, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Rush University Medical Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It focuses on psychological therapies for chronic pain, so it's best to discuss your medications with the trial coordinators.

What data supports the effectiveness of the treatment Acceptance and Commitment Therapy (ACT) for chronic pain?

Research shows that Acceptance and Commitment Therapy (ACT) can help people with chronic pain by improving their ability to manage pain, reducing depression, and lowering pain-related anxiety. Studies indicate that ACT is an effective and satisfactory treatment option for chronic pain, with participants reporting high levels of satisfaction.12345

Is Acceptance and Commitment Therapy (ACT) safe for treating chronic pain?

The research does not specifically address safety concerns, but Acceptance and Commitment Therapy (ACT) is generally considered safe for treating chronic pain, as it is a psychological intervention focusing on improving mental health and coping strategies.26789

How is the treatment Acceptance and Commitment Therapy (ACT) for chronic pain different from other treatments?

Acceptance and Commitment Therapy (ACT) is unique because it focuses on helping patients accept their pain and commit to living a meaningful life despite it, using mindfulness and psychological flexibility, rather than trying to eliminate the pain itself. This approach contrasts with traditional therapies that often aim to reduce or manage pain directly.1011121314

What is the purpose of this trial?

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.

Research Team

JW

John Burns, PhD

Principal Investigator

Rush University Medical Center

Eligibility Criteria

This trial is for adults in the US with chronic back or neck pain that's been present most days for at least 6 months, and who are fluent in English. Participants must have internet access, a computer/tablet, and be willing to attend weekly telehealth therapy sessions. People with certain medical conditions or recent major life stressors cannot join.

Inclusion Criteria

My main pain is in my back or neck, more than in my legs.
I want to try psychological therapy to manage my pain.
My pain level last week was 3 or higher on a scale of 0 to 10.
See 7 more

Exclusion Criteria

In the past 2 years, I have not had any of the listed conditions or treatments.
You have recently filed a claim for pain-related disability or worker's compensation.
I have a major medical procedure planned in the next 9 months.
See 2 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive individual therapy (CBT, ACT, or EAET) weekly for 8 weeks via telehealth

8 weeks
8 visits (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months
Post-treatment and 6-month follow-up assessments

Treatment Details

Interventions

  • Acceptance and Commitment Therapy
  • Cognitive Behavioral Therapy
  • Emotional Awareness and Expression Therapy
Trial Overview The study compares three psychological therapies—Cognitive Behavioral Therapy (CBT), Acceptance and Commitment Therapy (ACT), Emotional Awareness and Expression Therapy (EAET)—and usual treatment to see which is best at helping chronic spinal pain. Each therapy will be given individually over telehealth once a week for eight weeks.
Participant Groups
4Treatment groups
Experimental Treatment
Group I: Treatment As UsualExperimental Treatment1 Intervention
In this control condition, participants will engage in their usual care for neck/back pain with no additional experimental intervention
Group II: Emotional Awareness and Expression TherapyExperimental Treatment1 Intervention
8-session, individual, Emotional Awareness and Expression Therapy delivered remotely by skilled EAET
Group III: Cognitive Behavioral TherapyExperimental Treatment1 Intervention
8-session, individual, Cognitive Behavioral Therapy delivered remotely by skilled CBT therapists
Group IV: Acceptance and Commitment TherapyExperimental Treatment1 Intervention
8-session, individual, Acceptance and Commitment Therapy delivered remotely by skilled ACT therapists

Find a Clinic Near You

Who Is Running the Clinical Trial?

Rush University Medical Center

Lead Sponsor

Trials
448
Recruited
247,000+

Wayne State University

Collaborator

Trials
318
Recruited
111,000+

Findings from Research

In a study of 415 participants undergoing an ACT-based pain management program, three distinct psychological flexibility (PF) profiles were identified: low PF, low openness, and high awareness and action, indicating that individuals with chronic pain have varied psychological characteristics.
Despite these differences in baseline PF profiles, all subgroups showed similar responses to ACT treatment, suggesting that ACT may be effective across different psychological profiles, but further research is needed to tailor treatments to individual needs.
Predictors of outcomes following interdisciplinary acceptance and commitment therapy for chronic pain: Profiling psychological flexibility.Yu, L., McCracken, LM., Scott, W.[2022]
Acceptance and Commitment Therapy (ACT) has been shown to significantly improve various aspects of chronic pain management, including pain acceptance (SMD 0.67) and quality of life (SMD 0.43), based on a systematic review of 21 trials involving 1962 participants.
ACT not only reduces pain intensity (SMD -0.45) but also decreases anxiety (SMD -0.35) and depression (SMD -0.74), indicating its comprehensive benefits for individuals suffering from chronic pain.
The Efficacy of Acceptance and Commitment Therapy for Chronic Pain: A Systematic Review and Meta-analysis.Ma, TW., Yuen, AS., Yang, Z.[2023]
This systematic review and meta-analysis aims to evaluate the effectiveness of acceptance and commitment therapy (ACT) in improving functioning for individuals with chronic pain, utilizing randomized controlled trials as the basis for analysis.
The study will identify the most effective methods for implementing ACT, potentially leading to better management strategies for chronic pain, which is a widespread issue affecting many people's daily lives.
Acceptance and commitment therapy for chronic pain conditions on functioning: A systematic review protocol.Du, S., Dong, J., Jin, S., et al.[2021]

References

Predictors of outcomes following interdisciplinary acceptance and commitment therapy for chronic pain: Profiling psychological flexibility. [2022]
The Efficacy of Acceptance and Commitment Therapy for Chronic Pain: A Systematic Review and Meta-analysis. [2023]
Acceptance and commitment therapy for chronic pain conditions on functioning: A systematic review protocol. [2021]
Online Acceptance and Commitment Therapy (ACT) interventions for chronic pain: A systematic literature review. [2022]
A randomized, controlled trial of acceptance and commitment therapy and cognitive-behavioral therapy for chronic pain. [2022]
Acceptance and commitment therapy for chronic pain: protocol of a systematic review and individual participant data meta-analysis. [2023]
Acceptance and Commitment Therapy for chronic pain on functioning: A systematic review of randomized controlled trials. [2022]
ACTsmart: Guided Smartphone-Delivered Acceptance and Commitment Therapy for Chronic Pain-A Pilot Trial. [2023]
The Psychological Inflexibility in Pain Scale (PIPS) - validation, factor structure and comparison to the Chronic Pain Acceptance Questionnaire (CPAQ) and other validated measures in German chronic back pain patients. [2019]
10.United Statespubmed.ncbi.nlm.nih.gov
Current psychological approaches to the management of chronic pain. [2018]
[Acceptance and commitment therapy in the treatment of chronic pain]. [2019]
[Psychosocial treatment of pain at general practitioners and in specialist pain treatment units]. [2018]
[Behavioral concepts in the treatment of chronic pain]. [2018]
A feasibility study of brief group-based acceptance and commitment therapy for chronic pain in general practice: recruitment, attendance, and patient views. [2022]
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