Perioperative ACT for Preventing CPSP (PREPS)

Feasibility and Acceptability of a Single-session Perioperative Acceptance and Commitment Therapy (ACT) Workshop for Preventing Chronic Postsurgical Pain: A Single-arm, Non-randomized Pilot Trial

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.

Study Overview

• Status: Completed
• Conditions: Back Pain; Spinal Stenosis; Spondylosis; Spondylolisthesis; Back Injury
• Intervention / Treatment: Behavioral: Acceptance and Commitment Therapy

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Chestnut Hill, Massachusetts, United States, 01467
      • Brigham and Women's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Behavioral: Acceptance and Commitment Therapy; One day workshop + telephone booster

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment Helpfulness (THQ)	Item assesses the perceived helpfulness of the ACT workshop and is rated from -5 (extremely harmful) to 5 (extremely helpful).	1 month post-op
Treatment Credibility	Credibility and Expectancy Questionnaire (CEQ); 3 items are rated to indicate the logic, success, and confidence in the treatment. Scores are summed with a range from 3-27 where higher scores indicating greater treatment credibility	immediately following ACT workshop
Treatment Expectancy	Credibility and Expectancy Questionnaire (CEQ); 3 items are used to assess the likelihood of the success of the therapy to reduce pain and improve function. Scores are summed with a range from 0-29 where higher scores indicate greater expectancy for beneficial treatment outcomes	immediately following ACT workshop
Pain Interference	Assesses how much a person's pain impacts their daily activities, including general activity, mood, walking, work, relationships with others, enjoyment of life, and sleep, with higher scores indicating greater interference with daily functioning due to pain. Each of the seven domains is rated on a scale from 0 (no interference) to 10 (complete interference), and the average score across these domains represents the overall pain interference level.	1 month post-op
Pain Interference	The Brief Pain Inventory assesses how much a person's pain impacts their daily activities, including general activity, mood, walking, work, relationships with others, enjoyment of life, and sleep, with higher scores indicating greater interference with daily functioning due to pain. Each of the seven domains is rated on a scale from 0 (no interference) to 10 (complete interference), and the average score across these domains represents the overall pain interference level.	3 months post-op
Pain Interference	The Brief Pain Inventory assesses how much a person's pain impacts their daily activities, including general activity, mood, walking, work, relationships with others, enjoyment of life, and sleep, with higher scores indicating greater interference with daily functioning due to pain. Each of the seven domains is rated on a scale from 0 (no interference) to 10 (complete interference), and the average score across these domains represents the overall pain interference level.	6 months post-op
Pain Severity	The Brief Pain Inventory (BPI) measures pain severity by asking patients to rate their "worst pain" on a scale from 0 to 10, where a higher score indicates greater pain intensity	1 month post-op
Pain Severity	The Brief Pain Inventory (BPI) measures pain severity by asking patients to rate their "worst pain" on a scale from 0 to 10, where a higher score indicates greater pain intensity	3 months post-op
Pain Severity	The Brief Pain Inventory (BPI) measures pain severity by asking patients to rate their "worst pain" on a scale from 0 to 10, where a higher score indicates greater pain intensity	6 months post-op

Collaborators and Investigators

• Sponsor: Samantha Meints
• Collaborators: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Study record dates

Study Major Dates

• Study Start (Actual): January 4, 2023
• Primary Completion (Actual): March 30, 2026
• Study Completion (Actual): March 30, 2026

Study Registration Dates

• First Submitted: December 20, 2024
• First Submitted That Met QC Criteria: December 20, 2024
• First Posted (Actual): December 27, 2024

Study Record Updates

• Last Update Posted (Actual): May 1, 2026
• Last Update Submitted That Met QC Criteria: April 27, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: acceptance and commitment therapy; chronic postsurgical pain; ACT
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Bone Diseases; Musculoskeletal Diseases; Wounds and Injuries; Postoperative Complications; Pathologic Processes; Spinal Diseases; Spondylolysis; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Back Pain; Pain, Postoperative; Spinal Stenosis; Spondylosis; Spondylolisthesis; Back Injuries; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Cognitive Behavioral Therapy; Acceptance and Commitment Therapy
• Other Study ID Numbers: 2020A003336; K23AR077088 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Deidentified data will be shared.
• IPD Sharing Time Frame: Upon publication of the primary study manuscript
• IPD Sharing Access Criteria: Reasonable requests from IPD will be reviewed and granted by the study PI.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No