Loading clinical trials...
Loading clinical trials...
Telephone-Based Cognitive Behavioural Therapy for Post-Operative Bariatric Surgery Patients to Manage COVID-19 Pandemic Related Mental Health and Distress (TELE-BARICARE): A Randomized Controlled Trial to Determine Effectiveness and Adaptation for Marginalized Populations
Background: Over 60% of Canadians are overweight or obese and more than half have a history of a mental illness. The COVID-19 pandemic has made it difficult for people living with obesity to manage their weight even after undergoing bariatric surgery. These difficulties in combination with the stress of the pandemic can cause significant declines in mental health and well-being. Psychotherapy ("talk therapy") has been shown to be effective in helping to reduce mental health and disordered eating symptoms in patients managing obesity; however, there is limited data in the context of COVID-19. Objective: This study will examine whether providing a convenient and accessible telephone-based psychotherapy during and potentially after the COVID-19 pandemic will lead to better mental health and disordered eating-related outcomes in patients managing obesity after weight loss surgery. Hypothesis: Relative to the control group, those receiving psychotherapy will have lower mental health distress and eating disorder symptoms. Methods: Participants recruited from 4 weight loss surgery programs across Ontario will be randomly assigned to one of two groups: 1) Control (7 weekly non-structured check-in emails and access to online COVID-19 related mental health resources) or 2) Tele-CBT (a 7-session telephone-based cognitive behavioural therapy \[a type of "talk therapy"\] intervention focused on developing coping skills and specifically designed for weight loss surgery patients). Participants will complete measures of mental health distress, eating behaviours and a psychological distress scale prior to and immediately following the intervention. Implications: If Tele-CBT is found to improve post-pandemic mental health distress and eating behaviours, it could be routinely offered to patients with other chronic medical conditions as a resource to help manage psychological distress and mental health concerns emerging during and after the COVID-19 pandemic.
Background: High-risk patient populations, such as those with chronic or pre-existing medical conditions, including obesity, have experienced worsening mental health, distress and eating behaviours as a result of COVID-19. Given that 63% of Canadians are classified as overweight or obese, the mental health distress associated with COVID-19 has the potential to adversely impact obesity outcomes, such as weight loss and quality of life, in patients living with obesity or undergoing bariatric surgery. Preliminary evidence for virtual mental health interventions during COVID-19 has not identified any interventions that specifically addressed psychological distress or disordered eating in patients with obesity. This is a concern given significant shifts from in-person to virtual multidisciplinary visits across obesity and bariatric programs during the pandemic. Purpose and Research Plan: The purpose of the proposed research is to develop a virtual evidence-based treatment to improve disordered eating and psychological distress secondary to COVID-19 among diverse patients who are managing obesity after bariatric surgery. This study will be conducted in two parallel phases. Phase 1 is a multisite randomized controlled trial (RCT) to examine the efficacy of Tele-CBT vs. a control intervention in postoperative bariatric patients experiencing disordered eating and/or psychological distress. Qualitative exit interviews will also be conducted and data used to inform future adaptations of the intervention to meet patients' diverse needs during and post-pandemic. Phase 2 will consist of integrated knowledge translation and the creation of a diverse advisory committee to co-produce knowledge products and inform adaptation of Tele-CBT for diverse populations. Impact of Research: Given the increase in mental health distress and obesogenic behaviours related to the COVID-19 pandemic, it is critical that patients have consistent access to psychosocial care. Building off our previous research, this study aims to demonstrate that Tele-CBT is an efficacious intervention for those experiencing distress secondary to the COVID-19 pandemic and to mitigate pandemic-related deteriorations in mental health, disordered eating, and weight management in obesity care. Moreover, by understanding how virtually/remotely delivered psychological interventions during COVID-19 are received and affect diverse patient populations, our study findings will inform the development and application of psychosocial treatments and services during COVID-19 and its recovery phase. Through our advisory committee, key stakeholders, and community partnerships, the investigators will disseminate our findings widely and create a plan to implement virtual psychosocial interventions in obesity care to meet the mental health needs likely to persist post-pandemic.
Age
18 - 70 years
Sex
ALL
Healthy Volunteers
No
The Ottawa Hospital - Civic Campus
Ottawa, Ontario, Canada
Thunder Bay Regional Health Sciences Centre
Thunder Bay, Ontario, Canada
Humber River Hospital
Toronto, Ontario, Canada
Toronto Western Hospital
Toronto, Ontario, Canada
Start Date
October 6, 2022
Primary Completion Date
January 1, 2024
Completion Date
March 1, 2024
Last Updated
May 18, 2023
140
ESTIMATED participants
Tele-CBT
BEHAVIORAL
Self-Help Resources
OTHER
Lead Sponsor
University Health Network, Toronto
Collaborators
NCT01143454
NCT07472881
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and Conditions