| NCT ID | NCT05306665 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Brigham and Women's Hospital |
| Condition | Pain, Back |
| Study Type | INTERVENTIONAL |
| Enrollment | 140 participants |
| Start Date | 2023-01-13 |
| Primary Completion | 2026-08-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 140 participants in total. It began in 2023-01-13 with a primary completion date of 2026-08-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05306665 clinical trial?
This trial is open to participants of all sexes, aged 22 Years or older, studying Pain, Back. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05306665 currently recruiting?
Yes, NCT05306665 is actively recruiting participants. Contact the research team at smeints@bwh.harvard.edu for enrollment information.
Where is the NCT05306665 trial being conducted?
This trial is being conducted at Chestnut Hill, United States.
Who is sponsoring the NCT05306665 clinical trial?
NCT05306665 is sponsored by Brigham and Women's Hospital. The trial plans to enroll 140 participants.