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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a method to help people manage pain and reduce long-term opioid use after back surgery through Acceptance and Commitment Therapy (ACT), which emphasizes mindfulness and personal values. Participants will either attend a one-day ACT workshop with follow-up support or receive their usual treatment to determine which approach is more effective. The trial seeks individuals scheduled for specific back surgeries, such as fusion or discectomy, who have not undergone this type of therapy in the past two years. As an unphased trial, it offers a unique opportunity to explore innovative pain management techniques that could enhance recovery and quality of life.

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 prior data suggests that this ACT intervention is safe for post-surgery back pain?

Research shows that Acceptance and Commitment Therapy (ACT) is generally safe for people. Studies have found that ACT can help with pain, disability, and quality of life. These benefits appear both shortly after treatment and even six months later.

In past studies, ACT reduced the impact of pain on daily life and improved mental health issues like anxiety and depression. No serious negative effects were reported, suggesting that patients tolerate ACT well.

Overall, the safety information for ACT is encouraging, with no major problems reported in previous research. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the ACT intervention for post-surgery back pain because it offers a fresh approach by incorporating psychological strategies. Unlike traditional pain management treatments, which often rely on medications like opioids or physical therapy, ACT (Acceptance and Commitment Therapy) uses a mental health technique that encourages patients to accept their pain and commit to living a fulfilling life despite it. This approach is delivered through a 1-day workshop followed by a telephone booster, making it potentially more convenient and less invasive than ongoing medication or therapy sessions. By focusing on mental resilience and adaptation, ACT could offer a more holistic way to manage pain and improve quality of life after surgery.

What evidence suggests that the ACT intervention is effective for preventing chronic post-surgical pain and reducing opioid use?

Research has shown that Acceptance and Commitment Therapy (ACT) can help manage pain and improve quality of life. Studies have found that ACT may lessen the impact of pain on daily activities and reduce feelings of anxiety and depression. Additionally, ACT has helped people recover more quickly from pain after hip and knee surgeries. Some participants in this trial will receive the ACT intervention, which includes a 1-day workshop followed by a telephone booster after surgery. These findings suggest that ACT might prevent long-term pain and reduce the need for opioids after spine surgery. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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 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 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]

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

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10299249/

Effectiveness of Acceptance and Commitment Therapy (ACT ... There is evidence to suggest that this psychological therapy may be effective in improving pain interference, anxiety, depression, and quality of life.

2. sciencedirect.com sciencedirect.com/science/article/pii/S1526590024001597

Acceptability and Feasibility of a Single Session ... Acceptance and commitment therapy (ACT) has resulted in faster cessation of pain following hip and knee replacement surgery. However, this has not been assessed ...

3. researchgate.net researchgate.net/publication/371649194_Effectiveness_of_Acceptance_and_Commitment_Therapy_ACT_for_the_Management_of_Postsurgical_Pain_Study_Protocol_of_a_Randomized_Controlled_Trial_SPINE-ACT_Study

Study Protocol of a Randomized Controlled Trial (SPINE ... Secondary outcomes will include changes in pain intensity, anxiety, depression, pain catastrophizing, fear of movement, quality of life, ...

4. jpain.org jpain.org/article/S1526-5900(25)00577-2/fulltext

Effects of acceptance and commitment therapy plus ... Exploratory analyses revealed that ACT+Ex significantly improved pain intensity, disability, psychological inflexibility, HRQoL, and physical fitness at post- ...

5. mdpi.com mdpi.com/2077-0383/12/12/4066/review_report

Effectiveness of Acceptance and Commitment Therapy ... Effectiveness of Acceptance and Commitment Therapy (ACT) for the Management of Postsurgical Pain: Study Protocol of a Randomized Controlled ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6163061/

Acceptance and Commitment Therapy for Prevention ... Post-operative complications exhibited a moderating effect on these outcomes such that the effects of ACT were greater in patients without complications.

7. sciencedirect.com sciencedirect.com/science/article/pii/S1526590025005772

Effects of acceptance and commitment therapy plus ... ACT+Ex significantly improved pain intensity, disability, psychological inflexibility, HRQoL, and physical fitness at post-treatment and 6-month follow-up.

8. clinicaltrials.gov clinicaltrials.gov/study/NCT05306665?cond=%22Back%20Injuries%22&aggFilters=status:not%20rec&rank=3

Study Details | PREventing Pain After Surgery The present study aims to adapt and modify a brief presurgical Acceptance and Commitment Therapy (ACT) intervention aimed at preventing the transition to ...

9. mdpi.com mdpi.com/2077-0383/12/12/4066

Effectiveness of Acceptance and Commitment Therapy ... There is evidence to suggest that this psychological therapy may be effective in improving pain interference, anxiety, depression, and quality of life.

10. withpower.com withpower.com/trial/phase-back-injuries-3-2022-d6c0a

ACT Intervention for Post-Surgery Back Pain (PREPS Trial) The ACTsmart intervention, a smartphone-delivered acceptance and commitment therapy, showed significant improvements in pain interference among 34 adults with ...