Clinical trial NCT05258578: Tele-BARICARE to Manage COVID-19-Related Distress
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obesity
Bariatric Surgery Candidate
Mental Health Disorder
Eating Disorders
Keywords: Obesity
Bariatric Surgery
Mental Health
Disordered Eating
Cognitive Behavioural Therapy
Telephone Therapy
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: Centre for Addiction and Mental Health
name: Toronto Metropolitan University
name: The Ottawa Hospital
name: Humber River Hospital
name: Thunder Bay Regional Health Sciences Centre
First posted: 2022-02-28
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Binge Eating Scale
timeFrame: 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)
measure: Change in Patient Health Questionnaire-9 Item Scale
timeFrame: 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 outcomes:
measure: Emotional Eating Scale
timeFrame: 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)
measure: Change in Generalized Anxiety Disorder-7 Item Scale
timeFrame: 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)
measure: Change in Loss of Control Over Eating Scale
timeFrame: 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)
measure: Kessler Psychological Distress Scale
timeFrame: 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)
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: The Ottawa Hospital - Civic Campus
state: Ontario
city: Thunder Bay
country: Canada
facility: Thunder Bay Regional Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: Humber River Hospital
state: Ontario
city: Toronto
country: Canada
facility: Toronto Western Hospital
state: Ontario
Study officials:
affiliation: Toronto Metropolitan University
name: Stephanie E. Cassin, PhD, CPsych
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre for Addiction and Mental Health Research
name: Branka Agic, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sockalingam S, Leung SE, Agic B, Ma C, Hawa R, Wnuk S, Dash S, Jackson T, Akbar N, Forhan M, Cassin SE. 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. BMJ Open. 2022 Sep 15;12(9):e067393. doi: 10.1136/bmjopen-2022-067393.