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PREventing Pain After Surgery (PREPS)

Mass General Brigham logo

Mass General Brigham

Status

Enrolling

Conditions

Back Injuries
Disc Herniation
Pain, Back
Spondylolisthesis
Spinal Stenosis
Spondylosis

Treatments

Behavioral: ACT intervention

Study type

Interventional

Funder types

Other

Identifiers

NCT05306665
2022P002302

Details and patient eligibility

About

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.

Enrollment

140 estimated patients

Sex

All

Ages

22+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • scheduled to undergo fusion, discectomy, vertebroplasty, kyphoplasty, or foraminotomy
  • age 22 and older
  • able to communicate fluently in English

Exclusion criteria

  • inability to complete study procedures due to delirium, dementia, psychosis, or other cognitive impairment
  • have a history of severe neurologic movement disorder
  • are pregnant or intent to become pregnant during study
  • have undergone previous spinal surgery
  • have spinal deformity, pseudarthrosis, trauma, infection, or tumor as primary indication for surgery
  • have undergone Acceptance and Commitment Therapy in last 2 years

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

140 participants in 2 patient groups

ACT intervention
Experimental group
Description:
Participants assigned to this arm will complete a 1-day ACT workshop followed by a telephone booster after surgery
Treatment:
Behavioral: ACT intervention
Treatment As Usual
No Intervention group
Description:
Participants assigned to this arm will receive treatment as usual.

Trial contacts and locations

1

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Central trial contact

Marise Cornelius, MBA; Samantha M Meints, PhD

Data sourced from clinicaltrials.gov

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