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Completed

NCT Number: NCT06750874

Perioperative ACT for Preventing CPSP

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.

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Key information

Conditions

Back Pain Back Injuries Back Injury Bone Diseases Musculoskeletal Diseases Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms Spinal Diseases Spinal Stenosis Spondylolisthesis Spondylolysis Spondylosis Wounds and Injuries

Age range

22 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brigham and Women's Hospital

Chestnut Hill, Massachusetts, 01467, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Acceptance and Commitment Therapy

Behavioral

One day workshop + telephone booster

Primary outcomes

  1. Treatment helpfulness (THQ)

    Time frame: Immediately following the ACT workshop

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

Secondary outcomes

  1. Treatment Helpfulness (THQ)

    Time frame: 1 month post-op

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

  2. Treatment Credibility

    Time frame: immediately following ACT workshop

    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

  3. Treatment Expectancy

    Time frame: immediately following ACT workshop

    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

  4. Pain Interference

    Time frame: 1 month post-op

    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.

  5. Pain Interference

    Time frame: 3 months post-op

    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. Pain Interference

    Time frame: 6 months post-op

    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.

  7. Pain Severity

    Time frame: 1 month post-op

    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

  8. Pain Severity

    Time frame: 3 months post-op

    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

  9. Pain Severity

    Time frame: 6 months post-op

    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

Sponsors and collaborators

Lead sponsor

Samantha Meints

Other

Collaborators

  • National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Registry information

Official study title

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

Acronym: PREPS

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Dec 27, 2024
Registry last updated
May 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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