Tele-BARICARE to Manage COVID-19-Related Distress

Obesity Clinical Trial

— TELE-BARICARE  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05258578
• Other study ID #: 22-5145
• Status: Recruiting
• Phase: N/A
• Start date: October 6, 2022
• Est. completion date: March 2024

Study information

• Verified date: May 2023
• Source: University Health Network, Toronto
• Contact: Sanjeev Sockalingam, MD
• Phone: 416 535-8501
• Email: sanjeev.sockalingam[@]camh.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: March 2024
• Est. primary completion date: January 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• post-operative adult bariatric patients (men, women and gender diverse individuals)
• fluent in English
• have internet access to complete online questionnaires
• meet a threshold of = 5 on the Patient Health Questionnaire 9-Item scale (PHQ-9)24, a measure of depressive symptoms, or = 18 on the Binge Eating Scale (BES)26, a common measure of dysregulated eating in this patient population

Exclusion Criteria:

• current active suicidal ideation
• current poorly controlled medical illness or psychiatric illness that would render Tele-CBT very difficult (e.g., psychotic disorder, bipolar disorder)
• active COVID-19 infection as it may cause neuropsychiatric symptoms that impact treatment engagement and confound study outcomes

Related Conditions & MeSH terms

• Bariatric Surgery Candidate
• Disease
• Eating Disorders
• Feeding and Eating Disorders
• Mental Disorders
• Mental Health Disorder
• Obesity

Intervention

Behavioral:
• Tele-CBT
The Tele-CBT sessions focus on introducing the cognitive behavioural model of overeating and obesity, scheduling healthy meals and snacks, scheduling pleasurable alternative activities to overeating, identifying and planning for difficult eating scenarios, and problem solving and challenging negative thoughts. Participants are encouraged to complete CBT homework between sessions (i.e., completing food records, pleasurable activities and worksheets).

Other:
• Self-Help Resources
Participants will be directed to the CAMH COVID-19 Self-Help webpage (www.camh.ca/covid19) to access coping tools to help with COVID-19 associated stress and anxiety, loss, grief and healing, stigma, and physical isolation.

Locations

Country	Name	City	State
Canada	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

Sponsors (6)

Lead Sponsor	Collaborator
University Health Network, Toronto	Centre for Addiction and Mental Health, Humber River Hospital, Ryerson University, The Ottawa Hospital, Thunder Bay Regional Health Sciences Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Binge Eating Scale	The investigators will assess change in Binge Eating Scale (BES) scores at post-intervention and at 3-month follow-up compared to baseline. The BES is a 16-item self-report measure designed specifically for use with individuals with obesity and assesses the presence of binge eating characteristics indicative of an eating disorder. Scores on the BES range from 0 to 46 with moderate and severe levels of binge eating corresponding to cut-off scores of 18 and 27, respectively.	Baseline (pre-intervention, when participants are enrolled), post-intervention (approximately 3-months after patients complete baseline assessment), and 3-month follow-up (approximately 6 months after patients complete baseline assessment)
Primary	Change in Patient Health Questionnaire-9 Item Scale	The investigators will assess change in Patient Health Questionnaire-9 Item Scale (PHQ-9) scores at post-intervention and at 3-month follow-up compared to baseline. The PHQ-9 consists of 9-items assessing depressive symptoms on a scale ranging from 0 (not at all) to 3 (nearly every day). Scores on the PHQ-9 range from 0 to 27 with mild, moderate, moderately severe and severe levels of depressive symptoms corresponding to cut-off scores of 5, 10, 15 and 20, respectively.	Baseline (pre-intervention, when participants are enrolled), post-intervention (approximately 3-months after patients complete baseline assessment), and 3-month follow-up (approximately 6 months after patients complete baseline assessment)
Secondary	Emotional Eating Scale	The investigators will assess change in Emotional Eating Scale (EES) scores at post-intervention and at 3-month follow-up compared to baseline. The EES is a 25-item self-report measure that assesses a person's tendency to cope with negative affect through eating. The scale ranges from 0 (no desire) to 4 (overwhelming urge) and consists of questions that ask participants to rate the intensity of their urge to eat in response to 25 emotions. The EES is comprised of 3 subscales that reflect eating in response to anger/frustration, anxiety, and depression.	Baseline (pre-intervention, when participants are enrolled), post-intervention (approximately 3-months after patients complete baseline assessment), and 3-month follow-up (approximately 6 months after patients complete baseline assessment)
Secondary	Change in Generalized Anxiety Disorder-7 Item Scale	The investigators will assess change in Generalized Anxiety Disorder-7 Item Scale (GAD-7) scores at post-intervention and at 3-month follow-up compared to baseline. The GAD-7 is a 7-item self-report questionnaire assessing anxiety symptoms on a scale ranging from 0 (not at all) to 3 (nearly every day). Scores on the GAD-7 range from 0 to 21 with mild, moderate and severe levels of anxiety symptoms corresponding to cut-off scores of 5, 10 and 15, respectively.	Baseline (pre-intervention, when participants are enrolled), post-intervention (approximately 3-months after patients complete baseline assessment), and 3-month follow-up (approximately 6 months after patients complete baseline assessment)
Secondary	Change in Loss of Control Over Eating Scale	The investigators will assess change in Loss of Control Over Eating Scale (LOCES) scores at post-intervention and at 3-month follow-up compared to baseline. The LOCES is a 24-item self-report measure intended to measure a global sense of loss of control overeating. Higher scores on the LOCES indicate a greater level of LOC-eating.	Baseline (pre-intervention, when participants are enrolled), post-intervention (approximately 3-months after patients complete baseline assessment), and 3-month follow-up (approximately 6 months after patients complete baseline assessment)
Secondary	Kessler Psychological Distress Scale	The investigators will assess change in Kessler (K6) scores at post-intervention and at 3-month follow-up compared to baseline. The K6 is a 6-item self-report questionnaire measuring psychological distress. Questions are scored from 0 (none of the time) to 4 (all of the time). Low scores indicate low levels of psychological distress, whereas high scores indicate high levels of psychological distress.	Baseline (pre-intervention, when participants are enrolled), post-intervention (approximately 3-months after patients complete baseline assessment), and 3-month follow-up (approximately 6 months after patients complete baseline assessment)