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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ACT intervention | Experimental | Participants assigned to this arm will complete a 1-day ACT workshop followed by a telephone booster after surgery |
|
| Treatment As Usual | No Intervention | Participants assigned to this arm will receive treatment as usual. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ACT intervention | Behavioral | One day in person workshop + telephone booster |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Pain Interference |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Samantha M Meints, PhD | Contact | 6177329014 | smeints@bwh.harvard.edu | |
| Marise Cornelius, MBA | Contact | mcornelius@bwh.harvard.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham and Women's Hospital | Recruiting | Chestnut Hill | Massachusetts | 01467 | United States |
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.
The time of publication or shortly afterward.
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| ID | Term |
|---|---|
| D001416 | Back Pain |
| D013130 | Spinal Stenosis |
| D007405 | Intervertebral Disc Displacement |
| D055009 | Spondylosis |
| D013168 | Spondylolisthesis |
| D019567 | Back Injuries |
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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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 |
| 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 |
| 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 |
| Opioid dose | We will assess daily morphine equivalent doses using the ManageMyPain App and confirm via medical record review | 1 month post-op |
| Opioid dose | We will assess daily morphine equivalent doses using the ManageMyPain App and confirm via medical record review | 3 months post-op |
| Opioid dose | We will assess daily morphine equivalent doses using the ManageMyPain App and confirm via medical record review | 6 months post-op |
| 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 |
| 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 |
| 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 |
| Treatment Credibility | 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 | Immediately following ACT workshop |
| Treatment Expectancy | 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 | Immediately following ACT workshop |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013169 | Spondylolysis |
| D014947 | Wounds and Injuries |