Psychosocial Treatments for Chronic Pain
Recruiting in Palo Alto (17 mi)
+1 other location
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Rush University Medical Center
Disqualifiers: Epilepsy, Autoimmune, Cancer, Heart, others
No Placebo Group
Trial Summary
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.
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.
12345Is 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.
26789How 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.
1011121314Eligibility 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.
+8 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.
+2 more
Trial 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
Participant Groups
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.
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
Research Locations NearbySelect from list below to view details:
Rush University Medical CenterChicago, IL
Wayne State UniversityDetroit, MI
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Who Is Running the Clinical Trial?
Rush University Medical CenterLead Sponsor
Wayne State UniversityCollaborator
References
Predictors of outcomes following interdisciplinary acceptance and commitment therapy for chronic pain: Profiling psychological flexibility. [2022]Growing evidence demonstrates the benefit of acceptance and commitment therapy (ACT) for people with chronic pain. However, there remain people with chronic pain who do not benefit from ACT, and predicting treatment response is difficult.
The Efficacy of Acceptance and Commitment Therapy for Chronic Pain: A Systematic Review and Meta-analysis. [2023]Previous meta-analyses of a small number of trials showed that acceptance and commitment therapy (ACT) might improve chronic pain. Many new trials have been published afterward, and the factors that may impact the efficacy of ACT are less understood. We, therefore, conducted an updated systematic review with meta-analysis to investigate the efficacy of ACT for people with chronic pain.
Acceptance and commitment therapy for chronic pain conditions on functioning: A systematic review protocol. [2021]To explore the efficacy of acceptance and commitment therapy (ACT) on chronic pain in terms of functioning; and to identify the most promising modes and patterns for implementing ACT.
Online Acceptance and Commitment Therapy (ACT) interventions for chronic pain: A systematic literature review. [2022]We systematically reviewed all literature concerning online Acceptance and Commitment Therapy (ACT) interventions for chronic pain to evaluate their (1) ACT content, (2) design characteristics, (3) design rationales, and (4) adherence.
A randomized, controlled trial of acceptance and commitment therapy and cognitive-behavioral therapy for chronic pain. [2022]Individuals reporting chronic, nonmalignant pain for at least 6 months (N=114) were randomly assigned to 8 weekly group sessions of acceptance and commitment therapy (ACT) or cognitive-behavioral therapy (CBT) after a 4-6 week pretreatment period and were assessed after treatment and at 6-month follow-up. The protocols were designed for use in a primary care rather than specialty pain clinic setting. All participants remained stable on other pain and mood treatments over the course of the intervention. ACT participants improved on pain interference, depression, and pain-related anxiety; there were no significant differences in improvement between the treatment conditions on any outcome variables. Although there were no differences in attrition between the groups, ACT participants who completed treatment reported significantly higher levels of satisfaction than did CBT participants. These findings suggest that ACT is an effective and acceptable adjunct intervention for patients with chronic pain.
Acceptance and commitment therapy for chronic pain: protocol of a systematic review and individual participant data meta-analysis. [2023]Acceptance and commitment therapy (ACT) can be effective in treating chronic pain. Despite evidence supporting the effectiveness of ACT, uncertainties remain regarding which subgroups in the chronic pain population are likely to benefit most and least. This protocol describes the application for two meta-analytic approaches, one at the level of individual participant data and the other at the level of aggregated data, from randomized controlled trials of ACT for chronic pain (ACT-CP-MA).
Acceptance and Commitment Therapy for chronic pain on functioning: A systematic review of randomized controlled trials. [2022]Chronic pain is a worldwide health problem, Acceptance and Commitment Therapy (ACT) is regarded as one of the promising interventions. ACT aims to help chronic pain patients to create space for pursuing valued life activities in spite of pain. This systematic review of randomized controlled trials (RCTs) examined the efficacy of ACT on functioning for chronic pain. Literature search was performed among seven databases, and 12 RCTs were retrieved. The revised Cochrane risk of bias tool (RoB 2.0) was employed to assess the quality of the 12 RCTs, of which 10 were rated as "low risks", and 2 as "some concerns". Effect sizes of single RCTs and the pooled effect sizes of meta analyses were all rated by Grading of Recommendations Assessment, Development, and Evaluation (GRADE) system. Low to moderate evidence showed that ACT played a positive immediate role in functioning for patients with chronic pain; however, it is inconsistent whether the effect can be sustained. More RCTs are warranted within specific chronic pain conditions.
ACTsmart: Guided Smartphone-Delivered Acceptance and Commitment Therapy for Chronic Pain-A Pilot Trial. [2023]Acceptance and commitment therapy (ACT) is a behavioral health intervention with strong empirical support for chronic pain but, to date, widespread dissemination is limited. Digital solutions improve access to care and can be integrated into patients' everyday lives.
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]Acceptance and Commitment Therapy (ACT) for pain offers an alternative to traditional Cognitive Behavioural Therapy (CBT) approaches. ACT focuses on the enhancement of 'psychological flexibility' that enables individuals to pursue their values and goals despite pain. To assess specific treatment effect or mediators and moderators of change, questionnaires measuring ACT constructs are needed.
Current psychological approaches to the management of chronic pain. [2018]To provide a review of the rationale and evidence supporting three frequently used psychosocial interventions for chronic pain: cognitive-behavioral therapy, operant behavioral therapy and self-hypnosis training. We also review recent work in these areas, with an emphasis on the 2006 publishing year.
[Acceptance and commitment therapy in the treatment of chronic pain]. [2019]The purpose of this article is to present the characteristics of the Acceptance and Commitment Therapy (ACT) for the treatment of chronic pain. The historical context of the development of cognitive and behavioural therapy (CBT) for chronic pain will be described and the theoretical aspects of ACT will be introduced. The components of an acceptance and mindfulness based treatment will also be presented by exploring various processes of the psychological flexibility model. Finally, the article will summarize the scientific evidence supporting ACT based on experimental, correlational and clinical studies in the field of chronic pain.
[Psychosocial treatment of pain at general practitioners and in specialist pain treatment units]. [2018]Patients with complex chronic pain conditions are often difficult to treat with analgesia alone. Psychosocial intervention is needed to help them gain control and find an appropriate level of activity. This article summarizes the possibilities of psychosocial treatment of pain patients at the general practitioners and in specialist units of multidisciplinary pain treatment. The theoretical frame used is cognitive behavioural therapy. In practice, psychoeducation, mindfulness, and relaxation exercises are introduced to the patients to help them with daily life activity and work.
[Behavioral concepts in the treatment of chronic pain]. [2018]In recent decades there has been much work on cognitive behavioral approaches to chronic pain. Now there is a considerable variety of concepts and interventions which share the same roots but differ in theoretical issues and application. Psychotherapeutic interventions are ideally embedded into an interdisciplinary setting and base on a bio-psycho-social perspective. Starting from a classical operant model we will describe the model of fear avoidance and the model of acceptance in the therapy of chronic pain. The latter have been influencing therapy and theory in recent years. The cognitive behavioral perspective on chronic pain has, therefore, not only become more differentiated and complex but also more complicated.
A feasibility study of brief group-based acceptance and commitment therapy for chronic pain in general practice: recruitment, attendance, and patient views. [2022]Acceptance and commitment therapy (ACT), a form of cognitive-behavioral therapy, may help meet a need for accessible and cost-effective treatments for chronic pain. ACT has a growing evidence base, but has not yet been tested within general practice settings.