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Perioperative ACT for Preventing CPSP

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06750874
Acronym
PREPS
Enrollment
45
Registered
2024-12-27
Start date
2023-01-04
Completion date
2026-03-30
Last updated
2026-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Back Injury, Back Pain, Spinal Stenosis, Spondylolisthesis, Spondylosis

Keywords

acceptance and commitment therapy, chronic postsurgical pain, ACT

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.

Interventions

BEHAVIORALAcceptance and Commitment Therapy

One day workshop + telephone booster

Sponsors

Samantha Meints
Lead SponsorOTHER
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
CollaboratorNIH

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

Non-randomized, non-controlled pilot trial

Eligibility

Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Treatment helpfulness (THQ)Immediately following the ACT workshopItem assesses the perceived helpfulness of the ACT workshop and is rated from -5 (extremely harmful) to 5 (extremely helpful).

Secondary

MeasureTime frameDescription
Treatment Helpfulness (THQ)1 month post-opItem assesses the perceived helpfulness of the ACT workshop and is rated from -5 (extremely harmful) to 5 (extremely helpful).
Treatment Credibilityimmediately following ACT workshopCredibility 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
Treatment Expectancyimmediately following ACT workshopCredibility 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
Pain Interference1 month post-opAssesses 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.
Pain Severity1 month post-opThe 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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 2, 2026