Ignite Creation Date:
2024-05-06 @ 5:17 PM
Last Modification Date:
2024-10-26 @ 2:26 PM
Study NCT ID:
NCT05258578
Status:
RECRUITING
Last Update Posted:
2023-05-18
First Post:
2022-02-24
Brief Title:
Tele-BARICARE to Manage COVID-19-Related Distress
Sponsor:
University Health Network Toronto
Organization:
University Health Network Toronto
Study Overview
Official Title:
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
Status:
RECRUITING
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TELE-BARICARE
Brief Summary:
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
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
Detailed Description:
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 andor 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 virtuallyremotely 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
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 andor 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 virtuallyremotely 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None