Tele-BARICARE to Manage COVID-19-Related Distress

NCT05258578 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2023-05-18

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Centre for Addiction and Mental Health

    collaborator OTHER
  • Toronto Metropolitan University

    collaborator OTHER
  • The Ottawa Hospital

    collaborator OTHER
  • Humber River Hospital

    collaborator OTHER
  • Thunder Bay Regional Health Sciences Centre

    collaborator OTHER
  • University Health Network, Toronto

    lead OTHER

Principal Investigators

  • Stephanie E. Cassin, PhD, CPsych · Toronto Metropolitan University

  • Branka Agic, MD · Centre for Addiction and Mental Health Research

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-06
Primary Completion
2024-01-31
Completion
2024-03-31

Countries

  • Canada

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05258578 on ClinicalTrials.gov