Actively Recruiting
PREventing Pain After Surgery: Acceptance and Commitment Therapy to Prevent Chronic Post-Surgical Pain and Reduce Opioid Use
Led by Brigham and Women's Hospital · Updated on 2024-10-28
140
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to adapt and modify a brief presurgical Acceptance and Commitment Therapy (ACT) to help prevent Chronic Post-Surgical Pain (CPSP) and reduce long-term opioid use after lumbar spine surgery. The study will evaluate the acceptability, feasibility, and preliminary effectiveness of this intervention in preventing CPSP and lowering opioid use six months after surgery. Researchers will also explore psychosocial and psychophysical factors linked to how patients respond to the treatment. Participants will be randomly assigned to one of two groups. One group will attend a one-day, in-person ACT workshop before surgery and receive a follow-up telephone booster after surgery. The other group will receive treatment as usual without the ACT intervention. This behavioral approach is being studied to see if it can improve post-surgical outcomes. During the study, participants will complete assessments immediately after the ACT workshop and at one, three, and six months after surgery. These include measures of treatment helpfulness and credibility, pain intensity and interference, and opioid dosage. The main outcome is how helpful participants find the ACT workshop right after it is given. Researchers will monitor participants for six months following surgery to understand the intervention's impact and feasibility.
CONDITIONS
Brief Title
PREventing Pain After Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Scheduled for fusion, discectomy, vertebroplasty, kyphoplasty, or foraminotomy
- Age 22 years or older
- Able to communicate fluently in English
You will not qualify if you...
- Unable to complete study procedures due to delirium, dementia, psychosis, or other cognitive impairment
- History of severe neurologic movement disorder
- Pregnant or planning to become pregnant during the study
- Previous spinal surgery
- Spinal deformity, pseudarthrosis, trauma, infection, or tumor as primary reason for surgery
- Received Acceptance and Commitment Therapy in the last 2 years
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - From the workshop day through post-surgery recovery period
Participants assigned to the ACT intervention attend a one-day in-person workshop followed by a telephone booster after surgery. Participants in the usual care arm receive treatment as usual.
1 workshop visit (in-person) and 1 telephone booster visit
Duration - 6 months post-surgery
Participants are followed up for pain and opioid use outcomes for up to 6 months after surgery.
3 visits at 1 month, 3 months, and 6 months post-surgery
Trial Site Locations
Total: 1 location
1
Brigham and Women's Hospital
Chestnut Hill, Massachusetts, United States, 01467
Actively Recruiting
Research Team
S
Samantha M Meints, PhD
M
Marise Cornelius, MBA
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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