Perioperative ACT for Preventing CPSP

NCT06750874 | Completed

• 2 other identifiers: 2020A003336K23AR077088
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Back Pain; Spinal Stenosis; Spondylosis; Spondylolisthesis; Back Injury

Keywords

acceptance and commitment therapy; chronic postsurgical pain; ACT

Outcome Measures

Primary Outcomes (1)

• Treatment helpfulness (THQ)

  Item assesses the perceived helpfulness of the ACT workshop and is rated from -5 (extremely harmful) to 5 (extremely helpful).

  Immediately following the ACT workshop

Secondary Outcomes (9)

• Treatment Helpfulness (THQ)

  1 month post-op

• Treatment Credibility

  immediately following ACT workshop

• Treatment Expectancy

  immediately following ACT workshop

• Pain Interference

  1 month post-op

• Pain Interference

  3 months post-op

Study Arms (1)

Perioperative Acceptance and Commitment Therapy Workshop

EXPERIMENTAL

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

Behavioral: Acceptance and Commitment Therapy

Interventions

Acceptance and Commitment Therapy BEHAVIORAL

One day workshop + telephone booster

Perioperative Acceptance and Commitment Therapy Workshop

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Samantha Meints: lead
• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): collaborator

Study Sites (1)

Brigham and Women's Hospital

Chestnut Hill, Massachusetts, 01467, United States

Location

MeSH Terms

Conditions

Back Pain; Spinal Stenosis; Spondylosis; Spondylolisthesis; Back Injuries; Pain, Postoperative

Interventions

Acceptance and Commitment Therapy

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Spondylolysis; Wounds and Injuries; Postoperative Complications; Pathologic Processes

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Non-randomized, non-controlled pilot trial

Study Record Dates

• First Submitted: December 20, 2024
• First Posted: December 27, 2024
• Study Start: January 4, 2023
• Primary Completion: March 30, 2026
• Study Completion: March 30, 2026
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Upon publication of the primary study manuscript
• Access Criteria: Reasonable requests from IPD will be reviewed and granted by the study PI.

Locations

US (1)