Psychosocial Treatments for Chronic Pain

Recruiting at 1 trial location

Overseen By Mark A Lumley, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Rush University Medical Center

Disqualifiers: Epilepsy, Autoimmune, Cancer, Heart, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 14

Duration: 8 weeks

460 Participants Needed

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. ^{1 2 3 4 5}

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. ^{2 6 7 8 9}

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. ^{10 11 12 13 14}

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

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.

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.

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

Group I: Treatment As Usual Experimental Treatment 1 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 Therapy Experimental Treatment 1 Intervention

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

Group III: Cognitive Behavioral Therapy Experimental Treatment 1 Intervention

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

Group IV: Acceptance and Commitment Therapy Experimental Treatment 1 Intervention

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

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acceptance and commitment therapy for chronic pain conditions on functioning: A systematic review protocol. Du, S., Dong, J., Jin, S., et al.[2021]

A systematic review of 20 articles found that online Acceptance and Commitment Therapy (ACT) interventions for chronic pain are effective, particularly in studies that included randomized controlled trials (RCTs).

Most interventions were designed according to ACT principles and often included guidance, but many studies lacked detailed information on how design choices were made to enhance user engagement and adherence, which are important for maximizing effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Online Acceptance and Commitment Therapy (ACT) interventions for chronic pain: A systematic literature review. van de Graaf, DL., Trompetter, HR., Smeets, T., et al.[2022]

In a study of 114 individuals with chronic pain, acceptance and commitment therapy (ACT) showed significant improvements in pain interference, depression, and pain-related anxiety, indicating its efficacy as a treatment option.

Participants in the ACT group reported higher satisfaction levels compared to those in cognitive-behavioral therapy (CBT), suggesting that ACT may be a more acceptable adjunct intervention for managing chronic pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized, controlled trial of acceptance and commitment therapy and cognitive-behavioral therapy for chronic pain. Wetherell, JL., Afari, N., Rutledge, T., et al.[2022]

This study will conduct a comprehensive meta-analysis of Acceptance and Commitment Therapy (ACT) for chronic pain, including both individual participant data and aggregated data from randomized controlled trials, to identify which subgroups of chronic pain patients benefit most from ACT.

The outcomes will assess various factors such as pain interference, intensity, and overall quality of life, aiming to provide insights that could enhance future clinical trials and treatment decisions for chronic pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acceptance and commitment therapy for chronic pain: protocol of a systematic review and individual participant data meta-analysis. Lin, J., Scott, W., Carpenter, L., et al.[2023]

A systematic review of 12 randomized controlled trials involving Acceptance and Commitment Therapy (ACT) found low to moderate evidence that ACT positively impacts functioning in patients with chronic pain, with 10 studies rated as having low risk of bias.

While ACT shows promise for improving immediate functioning in chronic pain patients, the sustainability of these effects remains uncertain, indicating a need for further research in specific chronic pain conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acceptance and Commitment Therapy for chronic pain on functioning: A systematic review of randomized controlled trials. Du, S., Dong, J., Jin, S., et al.[2022]

The ACTsmart intervention, a smartphone-delivered acceptance and commitment therapy, showed significant improvements in pain interference among 34 adults with chronic pain after 8 weeks of treatment, with a large effect size (d = -1.01).

All secondary outcomes, including psychological flexibility and quality of life, also improved significantly and these benefits were maintained for up to 12 months, suggesting that ACTsmart is an effective and accessible treatment option for chronic pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

ACTsmart: Guided Smartphone-Delivered Acceptance and Commitment Therapy for Chronic Pain-A Pilot Trial. Gentili, C., Zetterqvist, V., Rickardsson, J., et al.[2023]

The Psychological Inflexibility in Pain Scale (PIPS) was validated in a German sample of 182 participants with chronic back pain, showing that the Avoidance subscale effectively predicts pain-related disability, highlighting its potential as a useful tool in assessing treatment processes for chronic pain.

The study found that the PIPS subscale Fusion had lower internal consistency and may not be as reliable in this population, suggesting that further research is needed to understand its relevance and the overall concept of psychological flexibility in chronic pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Barke, A., Riecke, J., Rief, W., et al.[2019]

Cognitive-behavioral therapy (CBT) and operant behavioral therapy are effective adjunctive treatments for chronic pain, with recent studies highlighting their role in addressing pain-related fears and adapting to specific patient groups.

Self-hypnosis training can provide temporary pain relief for many individuals with chronic pain, with some experiencing significant long-term reductions in pain, although its effectiveness is comparable to other relaxation techniques.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current psychological approaches to the management of chronic pain. Molton, IR., Graham, C., Stoelb, BL., et al.[2018]

Acceptance and Commitment Therapy (ACT) is an evidence-based approach that effectively complements traditional Cognitive Behavioral Therapy (CBT) in treating chronic pain, supported by various experimental and clinical studies.

ACT focuses on enhancing psychological flexibility through acceptance and mindfulness strategies, showing promise in improving the quality of life for individuals suffering from chronic pain, although further research is needed to fully understand its mechanisms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Acceptance and commitment therapy in the treatment of chronic pain]. Dionne, F., Blais, MC., Monestès, JL.[2019]

Patients with complex chronic pain conditions benefit from psychosocial interventions alongside traditional pain relief methods, as analgesia alone is often insufficient.

Cognitive behavioral therapy techniques, including psychoeducation, mindfulness, and relaxation exercises, are effective in helping patients manage their pain and improve daily functioning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Psychosocial treatment of pain at general practitioners and in specialist pain treatment units]. Handberg, G.[2018]

Cognitive behavioral approaches to chronic pain have evolved significantly, incorporating various concepts and interventions that emphasize a bio-psycho-social perspective, which is essential for effective treatment.

Recent models, such as fear avoidance and acceptance, have become influential in therapy for chronic pain, highlighting the increasing complexity and differentiation in cognitive behavioral strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Behavioral concepts in the treatment of chronic pain]. Kaiser, U., Nilges, P.[2018]

A study involving 481 potential participants with chronic pain showed that Acceptance and Commitment Therapy (ACT) is feasible to implement in general practice, with 73 participants allocated to either ACT plus usual care or usual care alone.

The majority of participants (70.3%) attended most ACT sessions and rated the treatment as credible, indicating that ACT could be a promising and acceptable option for managing chronic pain in primary care settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A feasibility study of brief group-based acceptance and commitment therapy for chronic pain in general practice: recruitment, attendance, and patient views. McCracken, LM., Sato, A., Wainwright, D., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Predictors of outcomes following interdisciplinary acceptance and commitment therapy for chronic pain: Profiling psychological flexibility. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

The Efficacy of Acceptance and Commitment Therapy for Chronic Pain: A Systematic Review and Meta-analysis. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Acceptance and commitment therapy for chronic pain conditions on functioning: A systematic review protocol. [2021]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Online Acceptance and Commitment Therapy (ACT) interventions for chronic pain: A systematic literature review. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

A randomized, controlled trial of acceptance and commitment therapy and cognitive-behavioral therapy for chronic pain. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Acceptance and commitment therapy for chronic pain: protocol of a systematic review and individual participant data meta-analysis. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Acceptance and Commitment Therapy for chronic pain on functioning: A systematic review of randomized controlled trials. [2022]

8. England pubmed.ncbi.nlm.nih.gov

ACTsmart: Guided Smartphone-Delivered Acceptance and Commitment Therapy for Chronic Pain-A Pilot Trial. [2023]

9. England pubmed.ncbi.nlm.nih.gov

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 States pubmed.ncbi.nlm.nih.gov

Current psychological approaches to the management of chronic pain. [2018]

11. Canada pubmed.ncbi.nlm.nih.gov

[Acceptance and commitment therapy in the treatment of chronic pain]. [2019]

12. Denmark pubmed.ncbi.nlm.nih.gov

[Psychosocial treatment of pain at general practitioners and in specialist pain treatment units]. [2018]

13. Germany pubmed.ncbi.nlm.nih.gov

[Behavioral concepts in the treatment of chronic pain]. [2018]

14. England pubmed.ncbi.nlm.nih.gov

A feasibility study of brief group-based acceptance and commitment therapy for chronic pain in general practice: recruitment, attendance, and patient views. [2022]