ACT Intervention for Post-Surgery Back Pain
(PREPS Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Brigham and Women's Hospital
Disqualifiers: Delirium, Dementia, Psychosis, Pregnancy, others
No Placebo Group
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.
12345Is 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.
13456How 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.
12457Eligibility 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.
+3 more
Trial 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
Participant Groups
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.
2Treatment groups
Experimental Treatment
Active Control
Group I: ACT interventionExperimental Treatment1 Intervention
Participants assigned to this arm will complete a 1-day ACT workshop followed by a telephone booster after surgery
Group II: Treatment As UsualActive Control1 Intervention
Participants assigned to this arm will receive treatment as usual.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Brigham and Women's HospitalChestnut Hill, MA
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Who Is Running the Clinical Trial?
Brigham and Women's HospitalLead Sponsor
References
ACTsmart: Guided Smartphone-Delivered Acceptance and Commitment Therapy for Chronic Pain-A Pilot Trial. [2023]Acceptance and commitment therapy (ACT) is a behavioral health intervention with strong empirical support for chronic pain but, to date, widespread dissemination is limited. Digital solutions improve access to care and can be integrated into patients' everyday lives.
Acceptance and commitment therapy for chronic pain conditions on functioning: A systematic review protocol. [2021]To explore the efficacy of acceptance and commitment therapy (ACT) on chronic pain in terms of functioning; and to identify the most promising modes and patterns for implementing ACT.
Acceptance and Commitment Therapy for Prevention of Chronic Postsurgical Pain and Opioid Use in At-Risk Veterans: A Pilot Randomized Controlled Study. [2023]High levels of pain, significant anxiety, or depressive symptoms before surgery put patients at elevated risk for chronic pain and prolonged opioid use following surgery. The purpose of this preliminary study was to assess the efficacy of a 1-day Acceptance and Commitment Therapy (ACT) workshop in "at-risk" veterans for the prevention of chronic pain and opioid use following orthopedic surgery. In a randomized controlled trial, 88 at-risk veterans undergoing orthopedic surgery were assigned to treatment as usual (TAU; n = 44) or TAU plus a 1-day ACT workshop (n = 44). Pain levels and opioid use were assessed up to 3 months following surgery. Pain acceptance and values-based behavior were assessed at baseline and 3-month follow-up. Participants who completed the ACT workshop reached pain and opioid cessation sooner than those in TAU. Postoperative complications exhibited a moderating effect on these outcomes, such that the effects of ACT were greater in patients without complications. Increases in pain acceptance and values-based behavior, processes targeted in ACT, were related to better outcomes. These promising results merit further investigation in a larger clinical trial. Providing an intervention before surgery for at-risk veterans has the potential to change clinical practice from a focus on management of postoperative pain to prevention of chronic pain in at-risk individuals.
Effectiveness of Acceptance and Commitment Therapy (ACT) for the Management of Postsurgical Pain: Study Protocol of a Randomized Controlled Trial (SPINE-ACT Study). [2023]Research on the use of Acceptance and Commitment Therapy (ACT) for patients with degenerative lumbar pathology awaiting surgery are limited. However, there is evidence to suggest that this psychological therapy may be effective in improving pain interference, anxiety, depression, and quality of life. This is the protocol for a randomized controlled trial (RCT) to evaluate the effectiveness of ACT compared to treatment as usual (TAU) for people with degenerative lumbar pathology who are candidates for surgery in the short term. A total of 102 patients with degenerative lumbar spine pathology will be randomly assigned to TAU (control group) or ACT + TAU (intervention group). Participants will be assessed after treatment and at 3-, 6-, and 12-month follow-ups. The primary outcome will be the mean change from baseline on the Brief Pain Inventory (pain interference). Secondary outcomes will include changes in pain intensity, anxiety, depression, pain catastrophizing, fear of movement, quality of life, disability due to low back pain (LBP), pain acceptance, and psychological inflexibility. Linear mixed models will be used to analyze the data. Additionally, effect sizes and number needed to treat (NNT) will be calculated. We posit that ACT may be used to help patients cope with the stress and uncertainty associated with their condition and the surgery itself.
Internet-Delivered Acceptance and Commitment Therapy for Adolescents with Chronic Pain and Their Parents: A Nonrandomized Pilot Trial. [2021]Acceptance and Commitment Therapy (ACT) is an empirically supported treatment for chronic pain in adults. There is also a small but growing evidence base of ACT for pediatric chronic pain. However, because of limited access to psychological treatment for pain, and geographical distances from pain facilities, many patients will not receive such treatment.
Psychological treatments for the management of postsurgical pain: a systematic review of randomized controlled trials. [2022]Inadequately managed pain is a risk factor for chronic postsurgical pain (CPSP), a growing public health challenge. Multidisciplinary pain-management programs with psychological approaches, including cognitive behavioral therapy (CBT), acceptance and commitment therapy (ACT), and mindfulness-based psychotherapy, have shown efficacy as treatments for chronic pain, and show promise as timely interventions in the pre/perioperative periods for the management of PSP. We reviewed the literature to identify randomized controlled trials evaluating the efficacy of these psychotherapy approaches on pain-related surgical outcomes.
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]Acceptance and commitment therapy (ACT) is a pragmatic approach to help individuals decrease avoidable pain.