Tele-CBT Following Bariatric Surgery: Randomized Control Trial

Study Overview
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Brief Summary
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Bariatric (weight loss) surgery is the most effective treatment for extreme obesity, but surgery does not treat underlying psychological and behavioural issues. Currently, psychotherapy (talk therapy) for eating problems is not routinely offered with surgery, and many people start to regain weight one year later. Objective: This study will examine if adding a convenient and accessible psychotherapy by phone one year after surgery will lead to increased weight loss two years after surgery. Primary Hypothesis: Relative to the Control group (who will get routine care), the group of individuals who get psychotherapy will have lower weights 2 years after surgery. Secondary Hypotheses: Relative to the Control group, the psychotherapy group will report significantly less maladaptive eating behaviours and medical burden, and significantly greater quality of life. Method: Participants recruited from the Bariatric Surgery Programs at Toronto Western Hospital will be randomly assigned to 1 of 2 groups: 1) Control (Usual Standard of Care) or 2) Tele-CBT (a 7-session telephone-based cognitive behavioural therapy [a type of talk therapy] intervention focused on developing coping skills to improve maladaptive thoughts, emotions, and eating behaviours, specifically designed for bariatric surgery patients, delivered 1 year post-surgery). They will have their weight measured and will complete measures of eating behaviour and quality of life prior to the intervention, and again at several time points extending to 2 years post-surgery. Implications: If Telephone-Cognitive Behavioural Therapy (CBT) is found to improve bariatric surgery outcomes, it could become the standard of care in Canadian bariatric surgery programs and beyond, and be routinely offered to patients who cannot feasibly attend CBT sessions due to physical or practical barriers.

Official Title
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Telephone-Based Cognitive Behavioural Therapy for Post-Operative Bariatric Surgery Patients: A Randomized Controlled Trial

Conditions
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Obesity

Intervention / Treatment
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* Behavioral: Telephone-Based CBT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Received bariatric surgery 1 year ago Fluent in English Have Internet access to complete online questionnaires. Exclusion Criteria: Current active suicidal ideation Current poorly controlled psychiatric illness that would render Tele-CBT very difficult, including serious mental illness (i.e., psychotic disorder, bipolar disorder), severe depression (i.e., current major depressive episode diagnosis and Patient Health Questionnaire [PHQ-9]61 score > 20), or severe anxiety (i.e., current anxiety disorder diagnosis and Generalized Anxiety Disorder [GAD-7]62 score >15) Current poorly controlled medical illness that would render Tele-CBT very difficult.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized Control Trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Treatment as Usual<br>Participants assigned to the Treatment as Usual group will attend routine clinic visits at the Toronto Western Hospital Bariatrics Surgery Program (TWH-BSP). These visits generally include education on bariatric surgery and nutrition. Patients meet with select members of the multidisciplinary team at 1, 2, and 3 years post-surgery, and may attend an optional monthly support group. Participants' service utilization (i.e., attendance at optional sessions) will be documented and compared across groups. | |
| Experimental: Telephone-Based CBT<br>The Tele-CBT intervention will be delivered 1 year following bariatric surgery. Participants will receive 6 weekly Telephone-based Cognitive Behavioural Therapy sessions and 1 final booster session 1 month later, all approximately 55-minutes in duration and scheduled at a time convenient for the participants. | Behavioral: Telephone-Based CBT<br>* The Tele-CBT sessions focus on introducing the cognitive behavioural model of overeating and obesity, scheduling healthy meals and snacks at regular time intervals and recording consumption using food records, scheduling pleasurable alternative activities to overeating, identifying and planning for difficult eating scenarios, and reducing vulnerability to overeating by solving problems and challenging negative thoughts. Participants are expected to complete CBT homework between sessions, such as completing food records, engaging in pleasurable and self-care activities, and completing a variety of worksheets.<br>* Other names: Tele-CBT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Weight | Change in weight measured in kg | 1.25, 1.5, 2, 3 years post-surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in obesity-related medical comorbidities - Medication Burden | Medication pill burden/Type 2 Diabetes Mellitus (T2DM) specific medication burden | 2 and 3 years post-surgery | 
| Changes in obesity-related medical comorbidities - Medical Treatments | Discontinuation of medical treatments | 2 and 3 years post-surgery | 
| Changes in obesity-related medical comorbidities - T2DM | Remission of T2DM (normalization of lab values discontinuation of medical treatments and remission of T2DM/normalization of lab values) | 2 and 3 years post-surgery | 
| Changes in eating pathology - Emotional Eating | Measured by the Emotional Eating Scale (EES). The EES is a 25-item self-report measure that assesses the tendency to cope with negative affect by eating. Respondents are presented with 25 emotions and are asked to rate the strength of their urge to eat on a scale from 1 (no desire to eat) to 5 (an overwhelming urge to eat) when experiencing each of the emotions. The total EES score is calculated as a sum of all 25 self-report answers. The EES consists of 3 subscales reflecting anger/frustration, anxiety, and depression. The EES subscale scores are calculated as a sum of all self-report answers of emotions that fall within the subscale categories. | 1.25, 1.5, 2, and 3 years post-surgery | 
| Changes in eating pathology - Binge Eating | Measured by the Binge Eating Scale (BES). The BES is a 16-item self-report measure that assesses the presence of binge eating behaviour indicative of an eating disorder. It was devised specifically for use with obese individuals. Respondents are asked to rate the way they feel about their eating behaviour from 1 (statements indicating they see no problem with their eating behaviour) to 4 (statements indicating they see a severe problem with their eating behaviour). Scores on the BES range from 0 to 46 with the total score calculated as a sum of all 16 self-report answers. Moderate and severe levels of binge eating correspond to cut-off scores of 18 and 27. | 1.25, 1.5, 2, and 3 years post-surgery | 
| Changes in eating pathology - Loss of Control | Measured by the Loss of Control over Eating Scale (LOCES-Brief). The LOCES-Brief is a 7-item self-report measure that assesses the behavioural and cognitive aspects of loss of control eating, which may occur even in the absence of objectively large eating binges. Respondents are asked to rate the frequency with which they have experienced loss of control over eating over the last month on a scale ranging from 1 (never) to 5 (always). Scores on the LOCES-Brief can range from 7 to 35 with the total score calculated as a sum of all 7 self-report answers. | 1.25, 1.5, 2, and 3 years post-surgery | 
| Changes in eating pathology - Depression | Measured by the Patient Health Questionnaire (PHQ-9). The PHQ-9 is a 9-item self-report measure of depression severity. Respondents are asked to rate the frequency with which they have experienced depressive symptoms over the last two weeks on a scale ranging from 0 (not at all) to 3 (nearly every day). Scores on the PHQ-9 can range from 0 to 27 with the total score calculated as a sum of all 9 self-report answers. Mild, moderate, moderately severe, and severe levels of depressive symptoms correspond to cut-off scores of 5, 10, 15, and 20 respectively. | 1.25, 1.5, 2, and 3 years post-surgery | 
| Changes in eating pathology - Quality of Life | Measured by the EuroQol (EQ-5D-5L). The EQ-5D-5L is a 25 item self-report measure of health-related quality of life. The EQ-5D-5L covers the 5 domains of mobility, self-care, daily activities, pain/discomfort, and anxiety/depression. Each domain consists of 5 statements ranging from I have no problems to I am unable to/I have extreme problems. Respondents are also asked to rate how good or bad their health is at the current point in time on a scale from 0 (worst health you can imagine) to 100 (best health you can imagine). | 1.25, 1.5, 2, and 3 years post-surgery | 
| Changes in eating pathology - Anxiety | Measured by the Generalized Anxiety Disorder Scale (GAD-7). The GAD-7 is a 7-item self report measure of anxiety severity. It was originally developed to diagnose generalized anxiety disorder, but it has also proved to be a good screening instrument for other disorders including panic disorder, social phobia, and post-traumatic stress disorder. Respondents are asked to rate the frequency with which they have experienced anxiety symptoms over the last two weeks on a scale ranging from 0 (not at all) to 3 (nearly every day). Scores on the GAD-7 can range from 0 to 21 with the total score calculated as a sum of all 7 self-report answers. Mild, moderate, and severe levels of anxiety symptoms correspond to cut-off scores on 5, 10, and 15 respectively. | 1.25, 1.5, 2, and 3 years post-surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obesity, Bariatric Surgery, Bariatrics, Cognitive Therapy, Binge Eating