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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05306665
Other study ID # 2022P002302
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 13, 2023
Est. completion date August 1, 2026

Study information

Verified date April 2024
Source Brigham and Women's Hospital
Contact Samantha M Meints, PhD
Phone 6177329014
Email smeints@bwh.harvard.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date August 1, 2026
Est. primary completion date August 1, 2026
Accepts healthy volunteers No
Gender All
Age group 22 Years and older
Eligibility 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 Design


Intervention

Behavioral:
ACT intervention
One day in person workshop + telephone booster

Locations

Country Name City State
United States Brigham and Women's Hospital Chestnut Hill Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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 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
Secondary 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
Secondary Opioid dose We will assess daily morphine equivalent doses using the ManageMyPain App and confirm via medical record review 1 month post-op
Secondary Opioid dose We will assess daily morphine equivalent doses using the ManageMyPain App and confirm via medical record review 3 months post-op
Secondary Opioid dose We will assess daily morphine equivalent doses using the ManageMyPain App and confirm via medical record review 6 months post-op
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
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