ACT Intervention for Post-Surgery Back Pain

(PREPS Trial)

Overseen By Marise Cornelius, MBA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Brigham and Women's Hospital

Disqualifiers: Delirium, Dementia, Psychosis, Pregnancy, others

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

Compensation: Varies

Number of Visits: 2

140 Participants Needed

Trial Summary

What is the purpose of this trial?

The present study aims to adapt and modify a brief presurgical Acceptance and Commitment Therapy (ACT) intervention aimed at preventing the transition to Chronic Post-Surgical Pain (CPSP) and reducing long-term opioid use. Investigators will then assess the acceptability, feasibility, and preliminary efficacy of the finalized intervention to prevent the transition to CPSP and reduce post-surgical opioid use six months following lumbar spine surgery. Finally, investigators will identify psychosocial and psychophysical phenotypes associated with response to this intervention.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment ACT intervention, Acceptance and Commitment Therapy, ACT, for post-surgery back pain?

Research shows that Acceptance and Commitment Therapy (ACT) is effective for managing chronic pain, improving pain acceptance, and reducing anxiety and depression. A study found that ACT helped veterans reduce pain and opioid use after surgery, suggesting it could be beneficial for post-surgery back pain as well. ^{1 2 3 4 5}

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

Acceptance and Commitment Therapy (ACT) has been studied for various conditions, including chronic pain and postsurgical pain, and is generally considered safe for humans. It is a psychological therapy that helps people manage pain and stress, and no significant safety concerns have been reported in the studies reviewed. ^{1 3 4 5 6}

How is the ACT treatment different from other treatments for post-surgery back pain?

ACT (Acceptance and Commitment Therapy) 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 entirely. This psychological approach can be delivered digitally, making it more accessible and integrated into daily life, unlike traditional pain management methods that often rely on medication or physical therapy. ^{1 2 4 5 7}

Eligibility Criteria

This trial is for adults aged 22 or older who are fluent in English and scheduled for specific lumbar spine surgeries like fusion or discectomy. It's not suitable for those with cognitive impairments, pregnant women, individuals who've had ACT therapy recently, previous spinal surgery patients, or cases involving spinal deformity due to causes like trauma or tumors.

Inclusion Criteria

I am scheduled for spine surgery.

I am 22 years old or older.

Able to communicate fluently in English

Exclusion Criteria

I do not have any mental conditions that would stop me from following the study's procedures.

I have participated in Acceptance and Commitment Therapy within the last 2 years.

I need surgery due to a spinal issue or tumor.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Presurgical Intervention

Participants complete a 1-day Acceptance and Commitment Therapy (ACT) workshop

1 day

1 visit (in-person)

Post-surgical Follow-up

Participants receive a telephone booster after surgery and are monitored for pain intensity and opioid use

6 months

1 call (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Treatment Details

Interventions

• ACT intervention

Trial Overview The study tests a brief Acceptance and Commitment Therapy (ACT) program designed to prevent chronic pain after lumbar spine surgery and reduce long-term opioid use. The effectiveness of this intervention will be evaluated six months post-surgery along with identifying patient characteristics that predict a good response.

Participant Groups

Group I: ACT intervention Experimental Treatment 1 Intervention

Participants assigned to this arm will complete a 1-day ACT workshop followed by a telephone booster after surgery

Group II: Treatment As Usual Active Control 1 Intervention

Participants assigned to this arm will receive treatment as usual.

Who Is Running the Clinical Trial?

Brigham and Women's Hospital

Lead Sponsor

Trials

1,694

Recruited

14,790,000+

Findings from Research

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]

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 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]

This study will evaluate the effectiveness of Acceptance and Commitment Therapy (ACT) in improving pain interference, anxiety, and quality of life in 102 patients with degenerative lumbar pathology awaiting surgery, comparing it to standard treatment.

The trial will assess various outcomes, including pain intensity and psychological factors, at multiple follow-up points, aiming to demonstrate that ACT can help patients better cope with the stress related to their condition and upcoming surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of Acceptance and Commitment Therapy (ACT) for the Management of Postsurgical Pain: Study Protocol of a Randomized Controlled Trial (SPINE-ACT Study). Castaño-Asins, JR., Sanabria-Mazo, JP., Luciano, JV., 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.

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]

A systematic review of five trials involving various surgical procedures found that cognitive behavioral therapy (CBT) significantly reduces pain intensity and disability in patients experiencing postsurgical pain.

The review highlights the need for further research to optimize the delivery and efficacy of CBT and explore newer psychological approaches for managing postsurgical pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychological treatments for the management of postsurgical pain: a systematic review of randomized controlled trials. Nicholls, JL., Azam, MA., Burns, LC., et al.[2022]

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]

References

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

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

2. England pubmed.ncbi.nlm.nih.gov

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

3. United States 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. [2023]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Effectiveness of Acceptance and Commitment Therapy (ACT) for the Management of Postsurgical Pain: Study Protocol of a Randomized Controlled Trial (SPINE-ACT Study). [2023]

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

Internet-Delivered Acceptance and Commitment Therapy for Adolescents with Chronic Pain and Their Parents: A Nonrandomized Pilot Trial. [2021]

6. New Zealand pubmed.ncbi.nlm.nih.gov

Psychological treatments for the management of postsurgical pain: a systematic review of randomized controlled trials. [2022]

7. Canada 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. [2020]