PREventing Pain After Surgery (PREPS)

PREventing Pain After Surgery: A Feasibility and Acceptability Study of Acceptance and Commitment Therapy for the Prevention of Chronic Post-surgical Pain (PREPS)

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.

Study Overview

• Status: Recruiting
• Conditions: Spinal Stenosis; Back Injuries; Spondylosis; Spondylolisthesis; Pain, Back; Disc Herniation
• Intervention / Treatment: Behavioral: ACT intervention

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Samantha M Meints, PhD; Phone Number: 6177329014; Email: smeints@bwh.harvard.edu
• Study Contact Backup: Name: Marise Cornelius, MBA; Email: mcornelius@bwh.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Chestnut Hill, Massachusetts, United States, 01467
      • Recruiting
      • Brigham and Women's Hospital
      • Contact: Samantha M Meints; Phone Number: 617-732-9014; Email: smeints@bwh.harvard.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years and older (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: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ACT intervention; Participants assigned to this arm will complete a 1-day ACT workshop followed by a telephone booster after surgery	Behavioral: ACT intervention; One day in person workshop + telephone booster
No Intervention: Treatment As Usual; Participants assigned to this arm will receive treatment as usual.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Interference	Patient Reported Outcomes Measurement Information System-29 (PROMIS-29); Items are rated from 1-5 and then summed with higher scores indicative of greater pain interference	3 months post-op
Treatment Helpfulness	Treatment Helpfulness Questionnaire (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
Pain Interference	Patient Reported Outcomes Measurement Information System-29 (PROMIS-29); Items are rated from 1-5 and then summed with higher scores indicative of greater pain interference	1 month post-op
Pain Interference	Patient Reported Outcomes Measurement Information System-29 (PROMIS-29); Items are rated from 1-5 and then summed with higher scores indicative of greater pain interference	6 month post-op
Opioid dose	We will assess daily morphine equivalent doses using the ManageMyPain App and confirm via medical record review	1 month post-op
Opioid dose	We will assess daily morphine equivalent doses using the ManageMyPain App and confirm via medical record review	3 months post-op
Pain Intensity	Patient Reported Outcomes Measurement Information System-29 (PROMIS-29); Values range from 0-10 with higher scores indicating greater pain intensity	1 month post-op
Pain Intensity	Patient Reported Outcomes Measurement Information System-29 (PROMIS-29); Values range from 0-10 with higher scores indicating greater pain intensity	3 months post-op
Pain Intensity	Patient Reported Outcomes Measurement Information System-29 (PROMIS-29); Values range from 0-10 with higher scores indicating greater pain intensity	6 months post-op
Opioid dose	We will assess daily morphine equivalent doses using the ManageMyPain App and confirm via medical record review	6 months post-op
Treatment Credibility	Credibility and Expectancy Questionnaire (CEQ); 3 items are rated 1 (not at all) to 9 (very) to indicate the logic, success, and confidence in the treatment. Scores are summed with higher scores indicating greater treatment credibility	Immediately following ACT workshop
Treatment Expectancy	Credibility and Expectancy Questionnaire (CEQ); 4 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 2-28 where higher scores indicate greater expectancy for beneficial treatment outcomes	Immediately following ACT workshop
Treatment Helpfulness	Treatment Helpfulness Questionnaire (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

Collaborators and Investigators

• Sponsor: Brigham and Women's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 13, 2023
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: February 23, 2022
• First Submitted That Met QC Criteria: March 23, 2022
• First Posted (Actual): April 1, 2022

Study Record Updates

• Last Update Posted (Actual): April 22, 2024
• Last Update Submitted That Met QC Criteria: April 19, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: opioid; Surgery; Chronic pain; acceptance and commitment therapy; Prevention
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Wounds and Injuries; Musculoskeletal Diseases; Pathological Conditions, Anatomical; Spinal Diseases; Bone Diseases; Hernia; Spondylolysis; Back Pain; Intervertebral Disc Displacement; Spinal Stenosis; Spondylosis; Spondylolisthesis; Back Injuries
• Other Study ID Numbers: 2022P002302

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The final dataset will be stripped of identifiers prior to release for sharing at the time of publication or shortly thereafter. The data will then be made available to approved outside collaborators under a data-sharing agreement that provides for (1) commitment to using the data only for research purposes; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying the data after analyses are completed. Further, the data will be shared via publication and/or public presentations.
• IPD Sharing Time Frame: The time of publication or shortly afterward.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No