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Tele-CBT Following Bariatric Surgery: Randomized Control Trial

Primary Purpose

Obesity

Status
Active
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Telephone-Based CBT
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, Bariatrics, Cognitive Therapy, Binge Eating

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Toronto Western Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Treatment as Usual

Telephone-Based CBT

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in Weight
Change in weight measured in kg

Secondary Outcome Measures

Changes in obesity-related medical comorbidities - Medication Burden
Medication pill burden/Type 2 Diabetes Mellitus (T2DM) specific medication burden
Changes in obesity-related medical comorbidities - Medical Treatments
Discontinuation of medical treatments
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)
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.
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.
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.
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.
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).
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.

Full Information

First Posted
August 31, 2017
Last Updated
May 16, 2022
Sponsor
University Health Network, Toronto
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1. Study Identification

Unique Protocol Identification Number
NCT03315247
Brief Title
Tele-CBT Following Bariatric Surgery: Randomized Control Trial
Official Title
Telephone-Based Cognitive Behavioural Therapy for Post-Operative Bariatric Surgery Patients: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 9, 2018 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Health Network, Toronto

4. Oversight

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

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Obesity, Bariatric Surgery, Bariatrics, Cognitive Therapy, Binge Eating

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized Control Trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
350 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment as Usual
Arm Type
No Intervention
Arm Description
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.
Arm Title
Telephone-Based CBT
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Telephone-Based CBT
Other 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 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.
Primary Outcome Measure Information:
Title
Change in Weight
Description
Change in weight measured in kg
Time Frame
1.25, 1.5, 2, 3 years post-surgery
Secondary Outcome Measure Information:
Title
Changes in obesity-related medical comorbidities - Medication Burden
Description
Medication pill burden/Type 2 Diabetes Mellitus (T2DM) specific medication burden
Time Frame
2 and 3 years post-surgery
Title
Changes in obesity-related medical comorbidities - Medical Treatments
Description
Discontinuation of medical treatments
Time Frame
2 and 3 years post-surgery
Title
Changes in obesity-related medical comorbidities - T2DM
Description
Remission of T2DM (normalization of lab values discontinuation of medical treatments and remission of T2DM/normalization of lab values)
Time Frame
2 and 3 years post-surgery
Title
Changes in eating pathology - Emotional Eating
Description
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.
Time Frame
1.25, 1.5, 2, and 3 years post-surgery
Title
Changes in eating pathology - Binge Eating
Description
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.
Time Frame
1.25, 1.5, 2, and 3 years post-surgery
Title
Changes in eating pathology - Loss of Control
Description
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.
Time Frame
1.25, 1.5, 2, and 3 years post-surgery
Title
Changes in eating pathology - Depression
Description
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.
Time Frame
1.25, 1.5, 2, and 3 years post-surgery
Title
Changes in eating pathology - Quality of Life
Description
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).
Time Frame
1.25, 1.5, 2, and 3 years post-surgery
Title
Changes in eating pathology - Anxiety
Description
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.
Time Frame
1.25, 1.5, 2, and 3 years post-surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sanjeev Sockalingam, MD, FRCPC
Organizational Affiliation
University of Toronto, University Health Network
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Stephanie Cassin, PhD, CPsych
Organizational Affiliation
Toronto Metropolitan University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Raed Hawa, MD, FRCPC
Organizational Affiliation
University of Toronto, University Health Network
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Susan Wnuk, PhD, CPsych
Organizational Affiliation
University of Toronto, University Health Network
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Timothy Jackson, MD, FRCPC
Organizational Affiliation
University of Toronto, University Health Network
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Lorraine Lipscombe, MD, FRCPC
Organizational Affiliation
Women's College Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Allan Okrainec, MD, FRCPC
Organizational Affiliation
University of Toronto, University Health Network
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
George Tomlinson, PhD
Organizational Affiliation
University of Toronto
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
David Urbach, MD, FRCPC
Organizational Affiliation
University of Toronto, University Health Network
Official's Role
Study Director
Facility Information:
Facility Name
Toronto Western Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T2S8
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Individual participant data (IPD) will not be shared publicly in order to protect patient confidentiality. Aggregate and anonymous data will be shared in peer reviewed journal articles and scientific presentations.
Citations:
PubMed Identifier
24347539
Citation
Meany G, Conceicao E, Mitchell JE. Binge eating, binge eating disorder and loss of control eating: effects on weight outcomes after bariatric surgery. Eur Eat Disord Rev. 2014 Mar;22(2):87-91. doi: 10.1002/erv.2273.
Results Reference
background
PubMed Identifier
25381119
Citation
Sheets CS, Peat CM, Berg KC, White EK, Bocchieri-Ricciardi L, Chen EY, Mitchell JE. Post-operative psychosocial predictors of outcome in bariatric surgery. Obes Surg. 2015 Feb;25(2):330-45. doi: 10.1007/s11695-014-1490-9.
Results Reference
background
PubMed Identifier
20510288
Citation
DiGiorgi M, Rosen DJ, Choi JJ, Milone L, Schrope B, Olivero-Rivera L, Restuccia N, Yuen S, Fisk M, Inabnet WB, Bessler M. Re-emergence of diabetes after gastric bypass in patients with mid- to long-term follow-up. Surg Obes Relat Dis. 2010 May-Jun;6(3):249-53. doi: 10.1016/j.soard.2009.09.019. Epub 2009 Oct 29.
Results Reference
background
PubMed Identifier
16954156
Citation
Shah M, Simha V, Garg A. Review: long-term impact of bariatric surgery on body weight, comorbidities, and nutritional status. J Clin Endocrinol Metab. 2006 Nov;91(11):4223-31. doi: 10.1210/jc.2006-0557. Epub 2006 Sep 5.
Results Reference
background
PubMed Identifier
35218006
Citation
Sockalingam S, Leung SE, Ma C, Hawa R, Wnuk S, Dash S, Jackson T, Cassin SE. The Impact of Telephone-Based Cognitive Behavioral Therapy on Mental Health Distress and Disordered Eating Among Bariatric Surgery Patients During COVID-19: Preliminary Results from a Multisite Randomized Controlled Trial. Obes Surg. 2022 Jun;32(6):1884-1894. doi: 10.1007/s11695-022-05981-6. Epub 2022 Feb 25. Erratum In: Obes Surg. 2022 Mar 18;:
Results Reference
derived

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Tele-CBT Following Bariatric Surgery: Randomized Control Trial

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