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Tele-CBT Following Bariatric Surgery: Randomized Control Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03315247
Recruitment Status : Active, not recruiting
First Posted : October 20, 2017
Last Update Posted : May 18, 2022
Sponsor:
Information provided by (Responsible Party):
Sanjeev Sockalingam, University Health Network, Toronto

Tracking Information
First Submitted Date  ICMJE August 31, 2017
First Posted Date  ICMJE October 20, 2017
Last Update Posted Date May 18, 2022
Actual Study Start Date  ICMJE February 9, 2018
Estimated Primary Completion Date December 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 16, 2017)
Change in Weight [ Time Frame: 1.25, 1.5, 2, 3 years post-surgery ]
Change in weight measured in kg
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 19, 2017)
  • Changes in obesity-related medical comorbidities - Medication Burden [ Time Frame: 2 and 3 years post-surgery ]
    Medication pill burden/Type 2 Diabetes Mellitus (T2DM) specific medication burden
  • Changes in obesity-related medical comorbidities - Medical Treatments [ Time Frame: 2 and 3 years post-surgery ]
    Discontinuation of medical treatments
  • Changes in obesity-related medical comorbidities - T2DM [ Time Frame: 2 and 3 years post-surgery ]
    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 [ Time Frame: 1.25, 1.5, 2, and 3 years post-surgery ]
    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 [ Time Frame: 1.25, 1.5, 2, and 3 years post-surgery ]
    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 [ Time Frame: 1.25, 1.5, 2, and 3 years post-surgery ]
    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 [ Time Frame: 1.25, 1.5, 2, and 3 years post-surgery ]
    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 [ Time Frame: 1.25, 1.5, 2, and 3 years post-surgery ]
    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 [ Time Frame: 1.25, 1.5, 2, and 3 years post-surgery ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 16, 2017)
  • Changes in obesity-related medical comorbidities - Medication Burden [ Time Frame: 2 and 3 years post-surgery ]
    Medication pill burden/Type 2 Diabetes Mellitus (T2DM) specific medication burden
  • Changes in obesity-related medical comorbidities - Medical Treatments [ Time Frame: 2 and 3 years post-surgery ]
    Discontinuation of medical treatments
  • Changes in obesity-related medical comorbidities - T2DM [ Time Frame: 2 and 3 years post-surgery ]
    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 [ Time Frame: 1.25, 1.5, 2, and 3 years post-surgery ]
    Measured by the Emotional Eating Scale (EES)
  • Changes in eating pathology - Binge Eating [ Time Frame: 1.25, 1.5, 2, and 3 years post-surgery ]
    Measured by the Binge Eating Scale (BES)
  • Changes in eating pathology - Loss of Control [ Time Frame: 1.25, 1.5, 2, and 3 years post-surgery ]
    Measured by the Loss of Control over Eating Scale
  • Changes in eating pathology - Depression [ Time Frame: 1.25, 1.5, 2, and 3 years post-surgery ]
    Measured by the Patient Health Questionnaire (PHQ-9)
  • Changes in eating pathology - Quality of Life [ Time Frame: 1.25, 1.5, 2, and 3 years post-surgery ]
    Measured by the EuroQol (EQ-5D)
  • Changes in eating pathology - Anxiety [ Time Frame: 1.25, 1.5, 2, and 3 years post-surgery ]
    Measured by the Generalized Anxiety Disorder Scale (GAD-7)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Tele-CBT Following Bariatric Surgery: Randomized Control Trial
Official Title  ICMJE Telephone-Based Cognitive Behavioural Therapy for Post-Operative Bariatric Surgery Patients: A Randomized Controlled Trial
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Randomized Control Trial
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Obesity
Intervention  ICMJE Behavioral: Telephone-Based CBT
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.
Other Name: Tele-CBT
Study Arms  ICMJE
  • No Intervention: Treatment as Usual
    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
    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: Behavioral: Telephone-Based CBT
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: October 16, 2017)
350
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2023
Estimated Primary Completion Date December 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03315247
Other Study ID Numbers  ICMJE 17-5655
376045 ( Other Grant/Funding Number: Canadian Institutes of Health Research (CIHR) )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
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.
Current Responsible Party Sanjeev Sockalingam, University Health Network, Toronto
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University Health Network, Toronto
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Sanjeev Sockalingam, MD, FRCPC University of Toronto, University Health Network
Principal Investigator: Stephanie Cassin, PhD, CPsych Toronto Metropolitan University
Study Director: Raed Hawa, MD, FRCPC University of Toronto, University Health Network
Study Director: Susan Wnuk, PhD, CPsych University of Toronto, University Health Network
Study Director: Timothy Jackson, MD, FRCPC University of Toronto, University Health Network
Study Director: Lorraine Lipscombe, MD, FRCPC Women's College Hospital
Study Director: Allan Okrainec, MD, FRCPC University of Toronto, University Health Network
Study Director: George Tomlinson, PhD University of Toronto
Study Director: David Urbach, MD, FRCPC University of Toronto, University Health Network
PRS Account University Health Network, Toronto
Verification Date May 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP