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Behavioral Intervention
ACT Intervention for Post-Surgery Back Pain (PREPS Trial)
N/A
Recruiting
Research Sponsored by Brigham and Women's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Scheduled to undergo fusion, discectomy, vertebroplasty, kyphoplasty, or foraminotomy
Age 22 and older
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 month post-op
Awards & highlights
PREPS Trial Summary
This trial is testing a modified version of a therapy called Acceptance and Commitment Therapy (ACT) to prevent patients from developing chronic pain after surgery, and to reduce their dependence on opioids.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Since the intervention involves psychological therapy rather than medication, traditional side effects are not expected. However, participants may experience emotional discomfort when engaging with new coping strategies taught during the ACT sessions.
PREPS Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am scheduled for spine surgery.
Select...
I am 22 years old or older.
PREPS Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 month post-op
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 month post-op
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Treatment Acceptability
Secondary outcome measures
Opioid dose
Pain Intensity
Pain Interference
PREPS Trial Design
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.
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Who is running the clinical trial?
Brigham and Women's HospitalLead Sponsor
1,611 Previous Clinical Trials
11,470,374 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am scheduled for spine surgery.I do not have any mental conditions that would stop me from following the study's procedures.I am 22 years old or older.I have participated in Acceptance and Commitment Therapy within the last 2 years.I need surgery due to a spinal issue or tumor.I have had surgery on my spine before.You have a history of severe movement problems related to the nervous system.
Research Study Groups:
This trial has the following groups:- Group 1: ACT intervention
- Group 2: Treatment As Usual
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is recruitment for this research currently open to participants?
"This clinical trial, first posted on August 22 2022 and last edited July 20th 2022, is not actively recruiting any longer. Yet, there are currently 416 other studies which are willing to accept participants."
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