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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how three different therapies can help reduce chronic back or neck pain. Researchers compare Cognitive Behavioral Therapy (CBT), Acceptance and Commitment Therapy (ACT), and Emotional Awareness and Expression Therapy (EAET) to determine which works best and for whom. Participants will attend weekly telehealth sessions over eight weeks. The trial suits those experiencing chronic back or neck pain at least four days a week for the past six months and seeking psychological therapy to improve their condition. As an unphased trial, it offers participants the opportunity to contribute to valuable research that may enhance future treatment options for chronic pain.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that the treatments tested in this trial—Cognitive Behavioral Therapy (CBT), Acceptance and Commitment Therapy (ACT), and Emotional Awareness and Expression Therapy (EAET)—are generally safe for people.

Studies indicate that CBT helps manage chronic pain by reducing pain and disability without major safety issues. It assists patients in changing negative thought patterns and is well-received even when conducted online.

Research has shown that ACT improves how people function despite their pain. Most patients respond well to ACT, although not everyone benefits equally. This therapy focuses on accepting pain and committing to a fulfilling life despite it.

EAET also shows promise. Studies suggest it can significantly reduce pain by helping people deal with emotions related to stress. Early trials reported large benefits with no major side effects.

In summary, these therapies are considered safe and aim to help patients manage chronic pain through mental and emotional strategies. They are generally well-tolerated, and any side effects are usually mild. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these psychosocial treatments for chronic pain because they offer diverse approaches that go beyond traditional medication. Acceptance and Commitment Therapy (ACT) helps patients develop psychological flexibility by focusing on values-based action despite pain, which is different from typical treatments that try to eliminate pain symptoms. Cognitive Behavioral Therapy (CBT) is well-known for modifying negative thought patterns and behaviors, providing tools for coping without medication. Emotional Awareness and Expression Therapy (EAET) encourages patients to express emotions related to their pain, potentially uncovering emotional drivers of physical symptoms. These therapies are delivered remotely, making them accessible and convenient, which is especially beneficial for individuals with chronic pain who may have mobility challenges.

What evidence suggests that this trial's treatments could be effective for chronic pain?

Research has shown that Cognitive Behavioral Therapy (CBT), one of the treatments in this trial, effectively manages chronic pain, often outperforming standard treatments. Studies indicate that CBT reduces pain and enhances daily activities. Acceptance and Commitment Therapy (ACT), another treatment option in this trial, also shows promise, with evidence suggesting it helps individuals manage chronic pain more effectively. ACT often matches other treatments in reducing pain's impact on daily life and improving overall quality of life. Emotional Awareness and Expression Therapy (EAET), also tested in this trial, stands out, with one study finding that 63% of participants experienced significant pain relief. EAET helps individuals process emotions related to their pain, making it particularly effective for chronic pain conditions. ^{2 4 6 7 8}

Who Is on the Research Team?

John Burns, PhD

Principal Investigator

Rush University Medical Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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) 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]

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]

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]

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]

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]

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 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]

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36827194/

The Efficacy of Acceptance and Commitment Therapy for ... ACT is effective and comparable to, if not better than, some other available active treatments for chronic pain.

2. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0301226

Acceptance and commitment therapy for patients with chronic ... The results showed that at post-treatment and three months post-treatment, ACT had small to large ES on pain interference, functional impairment ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S1526590023005394

Acceptance and Commitment Therapy for Chronic Pain: An ... Overall, however, randomized clinical trials and systematic reviews show that ACT can improve outcomes related to chronic pain (eg, pain-related functioning).

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38875241/

A systematic review and meta-analysis on psychological ... Post-treatment data highlight the efficacy of ACT in moderating pain-related outcomes. Clinical nurses are encouraged to incorporate ACT ...

5. tandfonline.com tandfonline.com/doi/full/10.1080/24740527.2025.2515106

The efficacy of a clustered group-based acceptance and ... A group-based ACT for chronic pain clustered into 3-day bouts may strengthen pain acceptance processes, including pain willingness and activity engagement.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11092929/

a systematic review and meta-analysis - PMC - PubMed Central The results suggest ACT improved outcomes in patients with FM: there was an overall improvement in all outcomes post-intervention, with most maintained at ...

7. bmcprimcare.biomedcentral.com bmcprimcare.biomedcentral.com/articles/10.1186/s12875-022-01690-2

Addressing chronic pain with Focused Acceptance and ... Findings support that FACT-CP was acceptable for patients with chronic pain and feasible for delivery in a primary care setting by a BHC.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9543918/

Predictors of outcomes following interdisciplinary acceptance ... There remain people with chronic pain who do not benefit from acceptance and commitment therapy (ACT), and predicting treatment response is difficult.