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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
Must not have
Inability to complete study procedures due to delirium, dementia, psychosis, or other cognitive impairment
Spinal deformity, pseudarthrosis, trauma, infection, or tumor as primary indication for surgery
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 month post-op
Awards & highlights
No Placebo-Only Group

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.
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.
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am scheduled for spine surgery.
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I am 22 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have any mental conditions that would stop me from following the study's procedures.
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I need surgery due to a spinal issue or tumor.
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I have had surgery on my spine before.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 month post-op
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 month post-op for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Opioid dose
Pain Intensity
Pain Interference
+3 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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.

Find a Location

Who is running the clinical trial?

Brigham and Women's HospitalLead Sponsor
1,666 Previous Clinical Trials
11,841,484 Total Patients Enrolled
2 Trials studying Spinal Stenosis
900 Patients Enrolled for Spinal Stenosis

Media Library

ACT intervention (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05306665 — N/A
Spinal Stenosis Research Study Groups: ACT intervention, Treatment As Usual
ACT intervention (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05306665 — N/A
Spinal Stenosis Clinical Trial 2023: ACT intervention Highlights & Side Effects. Trial Name: NCT05306665 — N/A
~67 spots leftby Aug 2026
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