search
Back to results

Tele-BARICARE to Manage COVID-19-Related Distress (TELE-BARICARE)

Primary Purpose

Obesity, Bariatric Surgery Candidate, Mental Health Disorder

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Tele-CBT
Self-Help Resources
Sponsored by
University Health Network, Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring Obesity, Bariatric Surgery, Mental Health, Disordered Eating, Cognitive Behavioural Therapy, Telephone Therapy

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Ottawa Hospital - Civic CampusRecruiting
  • Thunder Bay Regional Health Sciences CentreRecruiting
  • Humber River HospitalRecruiting
  • Toronto Western HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Tele-CBT Group

Self-Help Resources Group

Arm Description

Participants will receive 6 weekly Tele-CBT sessions and 1 final "booster" session 1 month later, all approximately 55-minutes in duration. Briefly, 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). Five clinical psychology graduate students will work as study therapists under the supervision of Drs. Cassin and Sockalingam and will have biweekly case supervision meetings.

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. Participants in the control arm will receive weekly check-in/reminder emails for the duration of the intervention period.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.
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.
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.

Full Information

First Posted
February 24, 2022
Last Updated
May 16, 2023
Sponsor
University Health Network, Toronto
Collaborators
Centre for Addiction and Mental Health, Toronto Metropolitan University, The Ottawa Hospital, Humber River Hospital, Thunder Bay Regional Health Sciences Centre
search

1. Study Identification

Unique Protocol Identification Number
NCT05258578
Brief Title
Tele-BARICARE to Manage COVID-19-Related Distress
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 6, 2022 (Actual)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
March 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Health Network, Toronto
Collaborators
Centre for Addiction and Mental Health, Toronto Metropolitan University, The Ottawa Hospital, Humber River Hospital, Thunder Bay Regional Health Sciences Centre

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Bariatric Surgery Candidate, Mental Health Disorder, Eating Disorders
Keywords
Obesity, Bariatric Surgery, Mental Health, Disordered Eating, Cognitive Behavioural Therapy, Telephone Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Tele-CBT Group
Arm Type
Experimental
Arm Description
Participants will receive 6 weekly Tele-CBT sessions and 1 final "booster" session 1 month later, all approximately 55-minutes in duration. Briefly, 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). Five clinical psychology graduate students will work as study therapists under the supervision of Drs. Cassin and Sockalingam and will have biweekly case supervision meetings.
Arm Title
Self-Help Resources Group
Arm Type
Active Comparator
Arm Description
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. Participants in the control arm will receive weekly check-in/reminder emails for the duration of the intervention period.
Intervention Type
Behavioral
Intervention Name(s)
Tele-CBT
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
Self-Help Resources
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Binge Eating Scale
Description
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.
Time Frame
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)
Title
Change in Patient Health Questionnaire-9 Item Scale
Description
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.
Time Frame
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 Outcome Measure Information:
Title
Emotional Eating Scale
Description
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.
Time Frame
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)
Title
Change in Generalized Anxiety Disorder-7 Item Scale
Description
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.
Time Frame
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)
Title
Change in Loss of Control Over Eating Scale
Description
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.
Time Frame
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)
Title
Kessler Psychological Distress Scale
Description
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.
Time Frame
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sanjeev Sockalingam, MD
Phone
416 535-8501
Ext
32178
Email
sanjeev.sockalingam@camh.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephanie E. Cassin, PhD, CPsych
Organizational Affiliation
Toronto Metropolitan University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Branka Agic, MD
Organizational Affiliation
Centre for Addiction and Mental Health Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Ottawa Hospital - Civic Campus
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1Y 4K7
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniella Sandre, PsyD, CPsych
Phone
613-798-5555
Ext
19592
Email
dasandre@toh.ca
Facility Name
Thunder Bay Regional Health Sciences Centre
City
Thunder Bay
State/Province
Ontario
ZIP/Postal Code
P7B 6V4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julie Riendeau, PhD, CPsych
Phone
807-684-6908
Email
riendeaj@tbh.net
Facility Name
Humber River Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M3M 0B2
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nadine Akbar, MD
Phone
416-242-1000
Ext
21203
Email
nakbar@hrh.ca
Facility Name
Toronto Western Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 2S8
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Samantha Leung, MSc
Phone
416-603-5800
Ext
3103
Email
samantha.leung@uhn.ca

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No IPD are to be shared with other researchers.
Citations:
PubMed Identifier
36109026
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.
Results Reference
derived

Learn more about this trial

Tele-BARICARE to Manage COVID-19-Related Distress

We'll reach out to this number within 24 hrs