Obesity Clinical Trial
— TELE-BARICAREOfficial 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
NCT number | NCT05258578 |
Other study ID # | 22-5145 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | October 6, 2022 |
Est. completion date | March 2024 |
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.
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 |
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 |
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 |
Canada,
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) |
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