CompletedNot Applicable

A Single Session Pain Psychology Class for Spine Surgery Patients

United States20 participantsStarted 2019-06-10

Plain-language summary

This project tests the feasibility a single session pain psychology class (TREK for Surgical Success) for patients undergoing spine surgery and compares outcomes in those who engage in the class to a historical group of similar patients undergoing usual care perioperatively. As of January 2020, the class option has been updated to include an online video module platform, to be used for patients unable to attend in person.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Adults 18 and older * Undergoing lumbar laminectomy with or without fusion Exclusion Criteria: * None

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Patient Satisfaction and Acceptability (change/durability of intervention acceptability)

Timeframe: immediately after the intervention and 12 weeks post surgery

Engagement Rates of CBT-P intervention

Timeframe: within 2 weeks before or 2 weeks after surgery

Change in Modified Oswestry Disability Index (MDQ) pre to post treatment

Timeframe: before surgery and 12 weeks post surgery

Change in Pain Castastrophizing pre and post treatment

Timeframe: before surgery and 12 weeks post surgery

Change in Depression

Timeframe: before surgery and 12 weeks post surgery

Change in PROMIS (Patient-Reported Outcomes Measurement Information System) Global Health Scale

Timeframe: before surgery and 12 weeks post surgery

Change in Opioid Use

Timeframe: immediately after the intervention, 12 weeks post surgery

Trial details

NCT IDNCT03985436

SponsorSara Davin, PsyD, MPH

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-11-01

View on ClinicalTrials.gov More Lumbar; Injury trials

Plain-language summary

What they're measuring

Patient Satisfaction and Acceptability (change/durability of intervention acceptability)

Timeframe: immediately after the intervention and 12 weeks post surgery

Engagement Rates of CBT-P intervention

Timeframe: within 2 weeks before or 2 weeks after surgery

Change in Modified Oswestry Disability Index (MDQ) pre to post treatment

Timeframe: before surgery and 12 weeks post surgery

Change in Pain Castastrophizing pre and post treatment

Timeframe: before surgery and 12 weeks post surgery

Change in Depression

Timeframe: before surgery and 12 weeks post surgery

Change in PROMIS (Patient-Reported Outcomes Measurement Information System) Global Health Scale

Timeframe: before surgery and 12 weeks post surgery

Change in Opioid Use

Timeframe: immediately after the intervention, 12 weeks post surgery