NCT05306665

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
3mo left

Started Jan 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress93%
Jan 2023Aug 2026

First Submitted

Initial submission to the registry

February 23, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 1, 2022

Completed
10 months until next milestone

Study Start

First participant enrolled

January 13, 2023

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2026

Last Updated

October 28, 2024

Status Verified

October 1, 2024

Enrollment Period

3.6 years

First QC Date

February 23, 2022

Last Update Submit

October 25, 2024

Conditions

Pain, BackSpinal StenosisDisc HerniationSpondylosisSpondylolisthesisBack Injuries

Keywords

Chronic painSurgeryopioidacceptance and commitment therapyPrevention

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (12)

  • Pain Interference

    1 month post-op

  • Pain Interference

    3 months post-op

  • Pain Interference

    6 month post-op

  • Treatment Helpfulness

    1 month post-op

  • Opioid dose

    1 month post-op

  • +7 more secondary outcomes

Study Arms (2)

ACT intervention

EXPERIMENTAL

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

Behavioral: ACT intervention

Treatment As Usual

NO INTERVENTION

Participants assigned to this arm will receive treatment as usual.

Interventions

ACT interventionBEHAVIORAL

One day in person workshop + telephone booster

ACT intervention

Eligibility Criteria

Age22 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brigham and Women's Hospital

Chestnut Hill, Massachusetts, 01467, United States

RECRUITING

MeSH Terms

Conditions

Back PainSpinal StenosisIntervertebral Disc DisplacementSpondylosisSpondylolisthesisBack InjuriesChronic Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSpinal DiseasesBone DiseasesMusculoskeletal DiseasesHerniaPathological Conditions, AnatomicalSpondylolysisWounds and Injuries

Central Study Contacts

Samantha M Meints, PhD

CONTACT

6177329014smeints@bwh.harvard.edu

Marise Cornelius, MBA

CONTACT

mcornelius@bwh.harvard.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Psychologist

Study Record Dates

First Submitted

February 23, 2022

First Posted

April 1, 2022

Study Start

January 13, 2023

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

August 1, 2026

Last Updated

October 28, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL
Time Frame
The time of publication or shortly afterward.

Locations

US(1)