Acceptance and Commitment Therapy for Chronic Post-Surgical Pain

Recruiting at 1 trial location

Overseen By Claire E Lunde

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Must not be taking: Illegal hard drugs

Disqualifiers: Severe cognitive impairment, psychiatric disorders, others

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

Compensation: Varies

Number of Visits: 1

Duration: 1 month

110 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how Acceptance and Commitment Therapy (ACT) can assist individuals with chronic post-surgical pain, defined as pain persisting for more than three months after surgery. The researchers aim to understand the brain's response to this pain and discover improved treatment methods, particularly for those unresponsive to current treatments. Participants will either attend a one-day group ACT session with a follow-up or continue their usual treatment. This trial suits individuals aged 12 and older who have experienced persistent pain for at least three months following major orthopedic surgery. As an unphased trial, it offers a unique opportunity to contribute to innovative research that could enhance pain management strategies.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are using illegal hard drugs, you cannot participate. Prescription medications containing similar compounds are allowed.

What prior data suggests that Acceptance and Commitment Therapy is safe for chronic post-surgical pain?

Studies have shown that Acceptance and Commitment Therapy (ACT) is generally safe for patients. Some research indicates that ACT can reduce the need for pain medication after surgery. Specifically, one study found that seven weeks post-surgery, 29% of patients using ACT continued taking opioids, compared to 52% of those who did not receive ACT. This suggests that ACT might manage pain with fewer side effects than medications. Additionally, ACT often improves how people accept and cope with pain, potentially helping them handle pain better without significant harm. Overall, ACT appears to be a safe option for managing chronic pain after surgery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Acceptance and Commitment Therapy (ACT) for chronic post-surgical pain (CPSP) is unique because it focuses on changing the relationship individuals have with their pain rather than trying to eliminate it outright. Unlike standard treatments for CPSP, which often include medications like opioids and physical therapy, ACT uses psychological techniques to help patients accept their pain and commit to living fulfilling lives despite it. Researchers are excited about ACT because it offers a non-drug approach that may reduce reliance on medications and their associated side effects, and it could improve mental well-being by teaching patients coping strategies that enhance their overall quality of life.

What evidence suggests that Acceptance and Commitment Therapy is effective for chronic post-surgical pain?

Research has shown that Acceptance and Commitment Therapy (ACT), which participants in this trial may receive, can help reduce pain after surgery. Specifically, it can speed up pain relief and decrease the need for painkillers after surgeries like hip and knee replacements. Some studies suggest that ACT also improves mood and reduces the impact of pain on daily activities. Overall, ACT helps patients manage their pain better and use fewer opioids, which are strong pain medications. This makes it a promising option for those dealing with ongoing pain after surgery. ^{1 3 6 7 8}

Who Is on the Research Team?

Christine B. Sieberg

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

This trial is for males and females aged 12 or older who have had surgery at least 6 months ago and are experiencing chronic pain that has lasted for more than 3 months post-surgery. Participants must be able to communicate in English or a language the research team can interpret. Those with severe cognitive impairments, significant psychiatric disorders, or illegal hard drug use are excluded.

Inclusion Criteria

I am 12 or older, had surgery over 6 months ago, and have had pain for 3 months or more after it.

Exclusion Criteria

I do not use illegal drugs, or if I do, they are prescribed.

I cannot communicate effectively in English or any language the research team understands.

You have a history of severe cognitive problems, such as intellectual disability or serious head injury.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a one-day (5 hours) group workshop based on Acceptance and Commitment Therapy (ACT) and a one-month post workshop zoom individual booster session

1 month

1 in-person workshop, 1 virtual booster session

Follow-up

Participants are monitored for changes in brain function and pain acceptance using fNIRS and CPAQ-R over a long-term period

5 years

What Are the Treatments Tested in This Trial?

Interventions

• Acceptance and Commitment Therapy

Trial Overview

The study aims to understand the psychophysical and neural mechanisms of chronic post-surgical pain (CPSP) across different ages. It will evaluate how Acceptance and Commitment Therapy may influence CPSP by examining neurobiological factors, providing metrics for patient follow-up, predicting chronification risks, and exploring age-related differences.

How Is the Trial Designed?

Group I: ACT Group Intervention Active Control 1 Intervention

We will evaluate the effects of an Acceptance and Commitment Therapy (ACT) one-day group intervention (with 1-month post group zoom booster session) on the functional near-infrared spectroscopy (fNIRS) signal in groups of adolescents and adult patients diagnosed with CPSP at \>3 months post major orthopedic surgery.

Group II: Treatment as Usual Active Control 1 Intervention

Treatment as Usual (TAU) for those with CPSP

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

Boston Children's Hospital

Lead Sponsor

Trials

801

Recruited

5,584,000+

Published Research Related to This Trial

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]

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 pilot study involving 28 adolescents aged 13-17 showed that an 8-week internet-delivered Acceptance and Commitment Therapy (ACT) significantly improved pain interference in adolescents (effect size d = 1.09) and pain reactivity in parents (effect size d = 0.70).

Despite some challenges in recruitment and compliance, the study indicates that internet-delivered ACT could be a feasible and effective treatment option for managing chronic pain in adolescents and their parents, warranting further research with larger randomized trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Internet-Delivered Acceptance and Commitment Therapy for Adolescents with Chronic Pain and Their Parents: A Nonrandomized Pilot Trial. Zetterqvist, V., Gentili, C., Rickardsson, J., et al.[2021]

The CPAQ-8, a shorter version of the Chronic Pain Acceptance Questionnaire, has been validated in a Swedish context and shows strong psychometric properties, including good internal consistency and a better fit for a 2-factor model compared to a 1-factor model.

This instrument is sensitive to treatment effects, effectively tracking rehabilitation changes in chronic pain patients, as indicated by a large effect size (d = 0.89) in a study involving 891 participants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychometric properties of the 8-item Chronic Pain Acceptance Questionnaire (CPAQ-8) in a Swedish chronic pain cohort. Rovner, GS., Arestedt, K., Gerdle, B., et al.[2019]

In a study of 302 chronic pain patients, guided online acceptance and commitment therapy (ACTonPain) significantly reduced pain interference compared to a control group, with a moderate effect size and a number needed to treat of 3.14.

The unguided ACTonPain group showed a significant reduction in depression levels compared to the control group after 6 months, indicating that both guided and unguided formats can be beneficial, though guided therapy was more effective for pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Internet-Based Intervention for Chronic Pain. Lin, J., Paganini, S., Sander, L., et al.[2020]

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]

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]

A 1-day Acceptance and Commitment Therapy (ACT) workshop significantly helped at-risk veterans undergoing orthopedic surgery to reduce pain and opioid use more quickly compared to those receiving standard treatment alone, based on a study of 88 participants.

The effectiveness of ACT was particularly pronounced in patients without postoperative complications, suggesting that preoperative interventions could shift the focus from managing pain to preventing chronic pain in at-risk individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acceptance and Commitment Therapy for Prevention of Chronic Postsurgical Pain and Opioid Use in At-Risk Veterans: A Pilot Randomized Controlled Study. Dindo, L., Zimmerman, MB., Hadlandsmyth, K., et al.[2023]

The study involved 82 patients who underwent orthopedic surgery, and those receiving an automated mobile messaging intervention based on Acceptance and Commitment Therapy (ACT) used 36.5% fewer opioid tablets compared to the control group, indicating a significant reduction in opioid consumption (P=0.004).

Patients in the ACT intervention group reported lower pain intensity scores after two weeks post-surgery (mean score of 45.9) compared to the control group (mean score of 49.7), suggesting that ACT may help in managing pain, although the difference may not be clinically significant (P=0.04).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acceptance and Commitment Therapy Delivered via a Mobile Phone Messaging Robot to Decrease Postoperative Opioid Use in Patients With Orthopedic Trauma: Randomized Controlled Trial. Anthony, CA., Rojas, EO., Keffala, V., et al.[2020]

Citations

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The primary outcomes are pain intensity and knee-specific functioning; secondary outcomes are symptoms of distress and coping skills. Mediation analyses will ...

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Seven weeks post-surgery, 29% of the patients in ACT and 52% of those in Usual Care were still taking opioids. Increases in pain acceptance and engagement in ...