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

NCT ID: NCT06750874

Last Updated: 2024-12-27

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

COMPLETED

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-04

Study Completion Date

2024-02-22

Brief Summary

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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.

Detailed Description

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Conditions

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Back Pain Spinal Stenosis Spondylosis Spondylolisthesis Back Injury

Keywords

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acceptance and commitment therapy chronic postsurgical pain ACT

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Non-randomized, non-controlled pilot trial
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Perioperative Acceptance and Commitment Therapy Workshop

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

Group Type EXPERIMENTAL

Acceptance and Commitment Therapy

Intervention Type BEHAVIORAL

One day workshop + telephone booster

Interventions

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Acceptance and Commitment Therapy

One day 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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National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

NIH

Sponsor Role collaborator

Samantha Meints

OTHER

Sponsor Role lead

Responsible Party

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Samantha Meints

Assistant Professor

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Brigham and Women's Hospital

Chestnut Hill, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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K23AR077088

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2020A003336

Identifier Type: -

Identifier Source: org_study_id