PREventing Pain After Surgery

NCT ID: NCT05306665

Last Updated: 2024-10-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-13

Study Completion Date

2026-08-01

Brief Summary

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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.

Detailed Description

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Conditions

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Pain, Back Spinal Stenosis Disc Herniation Spondylosis Spondylolisthesis Back Injuries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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ACT intervention

Participants assigned to this arm will complete a 1-day ACT workshop followed by a telephone booster after surgery

Group Type EXPERIMENTAL

ACT intervention

Intervention Type BEHAVIORAL

One day in person workshop + telephone booster

Treatment As Usual

Participants assigned to this arm will receive treatment as usual.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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ACT intervention

One day in person workshop + telephone booster

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

22 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Brigham and Women's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Samantha Meints

Clinical Psychologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Brigham and Women's Hospital

Chestnut Hill, Massachusetts, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Samantha M Meints, PhD

Role: CONTACT

6177329014

Marise Cornelius, MBA

Role: CONTACT

Facility Contacts

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Samantha M Meints

Role: primary

6177329014

Other Identifiers

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2022P002302

Identifier Type: -

Identifier Source: org_study_id

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