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Perioperative ACT for Preventing CPSP: a Single-arm Non-randomized Pilot Trial (PREPS)

S

Samantha Meints

Status

Completed

Conditions

Back Pain
Spondylolisthesis
Spinal Stenosis
Back Injury
Spondylosis

Treatments

Behavioral: Acceptance and Commitment Therapy

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT06750874
2020A003336
K23AR077088 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

The present study aims to adapt and modify a brief perioperative 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 assess the acceptability, feasibility, and preliminary efficacy of the intervention via a non-randomized, non-controlled pilot trial.

Enrollment

45 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

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

45 participants in 1 patient group

Perioperative Acceptance and Commitment Therapy Workshop
Experimental group
Description:
Participants assigned to this arm will complete a 1-day ACT workshop followed by a telephone booster after surgery
Treatment:
Behavioral: Acceptance and Commitment Therapy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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