110 Participants Needed

Acceptance and Commitment Therapy for Chronic Post-Surgical Pain

Recruiting at 1 trial location
CB
CE
Overseen ByClaire E Lunde
Age: Any Age
Sex: Any
Trial Phase: Academic
Sponsor: Massachusetts General Hospital
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

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 data supports the effectiveness of the treatment Acceptance and Commitment Therapy for chronic post-surgical pain?

Research shows that Acceptance and Commitment Therapy (ACT) is effective for managing chronic pain by helping people improve their daily functioning and cope better with pain. ACT has been successfully used in both adults and adolescents with chronic pain, and digital versions of the therapy have made it more accessible.12345

Is Acceptance and Commitment Therapy (ACT) safe for humans?

Acceptance and Commitment Therapy (ACT) has been studied for various conditions, including chronic pain, and is generally considered safe for humans. The research does not report any significant safety concerns, suggesting it is a safe treatment option.23567

How is Acceptance and Commitment Therapy different from other treatments for chronic post-surgical pain?

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, rather than trying to eliminate the pain itself. This approach is different from traditional pain treatments that often focus on reducing or managing pain symptoms directly.12389

What is the purpose of this trial?

The current project will (1) enhance our understanding of the neurobiology of chronic post-surgical pain (CPSP); (2) provide a metric to follow patients with CPSP in the clinic; (3) provide a metric for those who will chronify; and (4) understand the age-related differences in CPSP. Ultimately, an improved comprehension of mechanisms linked to CPSP will provide finer tools for optimizing the selection of treatments for individual patients. Moreover, data that demonstrates the underlying pathobiological pain mechanism(s) active in CPSP, particularly those non-responsive to current therapies, may be used to validate novel strategies both pharmacological and non-pharmacological.

Research Team

CB

Christine B. Sieberg

Principal Investigator

Massachusetts General Hospital

Eligibility Criteria

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.
See 1 more

Timeline

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

Treatment Details

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.
Participant Groups
2Treatment groups
Active Control
Group I: ACT Group InterventionActive Control1 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 UsualActive Control1 Intervention
Treatment as Usual (TAU) for those with CPSP

Find a Clinic Near You

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+

Findings from Research

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

References

Acceptance and commitment therapy for chronic pain conditions on functioning: A systematic review protocol. [2021]
ACTsmart: Guided Smartphone-Delivered Acceptance and Commitment Therapy for Chronic Pain-A Pilot Trial. [2023]
Internet-Delivered Acceptance and Commitment Therapy for Adolescents with Chronic Pain and Their Parents: A Nonrandomized Pilot Trial. [2021]
Predictors of outcomes following interdisciplinary acceptance and commitment therapy for chronic pain: Profiling psychological flexibility. [2022]
An Internet-Based Intervention for Chronic Pain. [2020]
Acceptance and Commitment Therapy for Prevention of Chronic Postsurgical Pain and Opioid Use in At-Risk Veterans: A Pilot Randomized Controlled Study. [2023]
Acceptance and Commitment Therapy Delivered via a Mobile Phone Messaging Robot to Decrease Postoperative Opioid Use in Patients With Orthopedic Trauma: Randomized Controlled Trial. [2020]
Psychometric properties of the 8-item Chronic Pain Acceptance Questionnaire (CPAQ-8) in a Swedish chronic pain cohort. [2019]
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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