Tele-BARICARE to Manage COVID-19-Related Distress

NCT05258578 | Unknown

• 1 other identifier: 22-5145
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 4

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.

Conditions

Obesity; Bariatric Surgery Candidate; Mental Health Disorder; Eating Disorders

Keywords

Obesity; Bariatric Surgery; Mental Health; Disordered Eating; Cognitive Behavioural Therapy; Telephone Therapy

Outcome Measures

Primary Outcomes (2)

• 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)

• 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 Outcomes (4)

• Emotional Eating Scale

  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)

• Change in Generalized Anxiety Disorder-7 Item Scale

  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)

• Change in Loss of Control Over Eating Scale

  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)

• Kessler Psychological Distress Scale

  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)

Study Arms (2)

Tele-CBT Group

EXPERIMENTAL

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.

Behavioral: Tele-CBT

Self-Help Resources Group

ACTIVE COMPARATOR

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.

Other: Self-Help Resources

Interventions

Tele-CBT BEHAVIORAL

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).

Tele-CBT Group

Self-Help Resources OTHER

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.

Self-Help Resources Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Health Network, Toronto: lead
• Centre for Addiction and Mental Health: collaborator
• Toronto Metropolitan University: collaborator
• The Ottawa Hospital: collaborator
• Humber River Hospital: collaborator
• Thunder Bay Regional Health Sciences Centre: collaborator

Study Sites (4)

The Ottawa Hospital - Civic Campus

Ottawa, Ontario, K1Y 4K7, Canada

RECRUITING

Thunder Bay Regional Health Sciences Centre

Thunder Bay, Ontario, P7B 6V4, Canada

RECRUITING

Humber River Hospital

Toronto, Ontario, M3M 0B2, Canada

RECRUITING

Toronto Western Hospital

Toronto, Ontario, M5T 2S8, Canada

RECRUITING

Related Publications (1)

• 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.

  PMID: 36109026 DERIVED

MeSH Terms

Conditions

Obesity; Mental Disorders; Feeding and Eating Disorders; Psychological Well-Being

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive; Personal Satisfaction; Behavior

Study Officials

• Stephanie E. Cassin, PhD, CPsych

  Toronto Metropolitan University

  PRINCIPAL INVESTIGATOR

• Branka Agic, MD

  Centre for Addiction and Mental Health Research

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sanjeev Sockalingam, MD

CONTACT

416 535-8501; sanjeev.sockalingam@camh.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 24, 2022
• First Posted: February 28, 2022
• Study Start: October 6, 2022
• Primary Completion: January 1, 2024
• Study Completion: March 1, 2024
• Last Updated: May 18, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (4)