Telephone-based cognitive behavioural therapy for patients with postoperative bariatric surgery to manage COVID-19 pandemic-related mental health issues and distress (TELE-BARICARE): a protocol for a randomised controlled trial
Bibliographic record
Abstract
INTRODUCTION: Bariatric surgery is currently the most effective treatment for obesity, and is performed yearly in over 8000 patients in Canada. Over 50% of those who live with obesity also have a history of mental health disorder. The COVID-19 pandemic has made it difficult for people living with obesity to manage their weight even after undergoing bariatric surgery, which combined with pandemic-related increases in mental health distress, has the potential to adversely impact obesity outcomes such as weight loss and quality of life. Reviews of virtual mental health interventions during COVID-19 have not identified any interventions that specifically address psychological distress or disordered eating in patients with obesity, including those who have had bariatric surgery. METHODS AND ANALYSIS: A randomised controlled trial will be conducted with 140 patients across four Ontario Bariatric Centres of Excellence to examine the efficacy of a telephone-based cognitive behavioural therapy intervention versus a control intervention (online COVID-19 self-help resources) in postoperative bariatric patients experiencing disordered eating and/or psychological distress. Patients will be randomised 1:1 to either group. Changes in the Binge Eating Scale and the Patient Health Questionnaire 9-Item Scale will be examined between groups across time (primary outcomes). Qualitative exit interviews will be conducted, and data will be used to inform future adaptations of the intervention to meet patients' diverse needs during and post-pandemic. ETHICS AND DISSEMINATION: This study has received ethics approvals from the following: Clinical Trials Ontario (3957) and the University Health Network Research Ethics Committee (22-5145), the Board of Record. All participants will provide written informed consent prior to enrolling in the study. Results will be made available to patients with bariatric surgery, the funders, the supporting organisations and other researchers via publication in peer-reviewed journals and conference presentations. TRIAL REGISTRATION NUMBER: NCT05258578.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.044 | 0.037 |
| Meta-epidemiology (narrow) | 0.007 | 0.004 |
| Meta-epidemiology (broad) | 0.013 | 0.006 |
| Bibliometrics | 0.004 | 0.004 |
| Science and technology studies | 0.004 | 0.004 |
| Scholarly communication | 0.005 | 0.005 |
| Open science | 0.005 | 0.003 |
| Research integrity | 0.011 | 0.009 |
| Insufficient payload (model declined to judge) | 0.085 | 0.015 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".