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Telephone-based Cognitive Behavioral Therapy for Bariatric Surgery Patients: A Pilot Study

Primary Purpose

Obesity, Eating Disorder

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Telephone Based Cognitive Behavioral Therapy
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 Bariatric surgery, Cognitive Behavioral Therapy, Telephone based CBT, Obesity

Eligibility Criteria

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

Inclusion Criteria:

  • Fluent in English
  • Have access to telephone and computer with internet access
  • Have the capacity to provide informed consent

Exclusion Criteria:

  • Active suicidal ideation
  • Serious mental illness
  • Active severe depression
  • Active severe anxiety
  • Active post traumatic stress disorder

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Pre-Op CBT

    Post-Op CBT

    Arm Description

    This group will receive CBT (Telephone Based Cognitive Behavioral Therapy) before bariatric surgery

    This group will receive CBT (Telephone Based Cognitive Behavioral Therapy) after bariatric surgery

    Outcomes

    Primary Outcome Measures

    Changes in Depression severity
    Measured with "Patient Health Questionnaire" (PHQ-9),a 9-item self-report measure of depression severity
    Changes in Anxiety severity
    Measured by "Generalized Anxiety Disorder Questionnaire" (GAD-7) ,a 7-item self report measure of anxiety severity
    Changes in Health-related quality of life
    Measured by "Short-Form Health Survey" (SF-36), a 36-item self-report measure of health-related quality of life.
    Changes in eating pathology
    Measured by the "Binge Eating Scale" (BES) and "Emotional Eating Scale" (EES). The BES is a 16-item self-report measure designed specifically for use with obese individuals that assesses binge eating behaviors as well as associated cognitions and emotions. The EES is a 25-item self-report measure that assesses the tendency to cope with negative affect by eating.

    Secondary Outcome Measures

    Comparing improvements on the outcome of Tele-CBT before and after bariatric surgery
    Half the subjects will receive the CBT intervention prior to surgery, and half will receive it after surgery; they will be followed until 1 year post surgery.

    Full Information

    First Posted
    December 22, 2011
    Last Updated
    July 14, 2015
    Sponsor
    University Health Network, Toronto
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01508585
    Brief Title
    Telephone-based Cognitive Behavioral Therapy for Bariatric Surgery Patients: A Pilot Study
    Official Title
    Telephone-based Cognitive Behavioral Therapy for Bariatric Surgery Patients: A Pilot Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2012 (undefined)
    Primary Completion Date
    December 2014 (Actual)
    Study Completion Date
    December 2014 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Bariatric surgery is the most effective treatment for patients with extreme obesity. Psychological interventions are not routinely offered in Bariatric Surgery Programs. Preliminary evidence suggests that Cognitive Behavioral Therapy (CBT) might be effective in reducing binge eating and improving surgical outcomes. The current study will examine whether the addition of telephone-based CBT (Tele-CBT) to the usual standard of care is more effective than the usual standard of care alone, and whether it is more effective when delivered prior to or following bariatric surgery.
    Detailed Description
    Preliminary research suggests that CBT might be effective in reducing eating pathology and improving surgical outcomes. However, previous studies have examined group-based CBT delivered in person, and most patients cannot feasibly attend weekly therapy appointments at the hospital. Telephone-based CBT offers greater convenience because the service can be delivered during the evening and weekends, and eliminates the need to leave work and travel to hospital appointments. No published studies have examined the effectiveness or feasibility of telephone-based CBT for bariatric surgery patients. This study will examine the effectiveness of Tele-CBT as an adjunctive treatment to the usual standard of care in bariatric surgery patients.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Obesity, Eating Disorder
    Keywords
    Bariatric surgery, Cognitive Behavioral Therapy, Telephone based CBT, Obesity

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    47 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Pre-Op CBT
    Arm Type
    Active Comparator
    Arm Description
    This group will receive CBT (Telephone Based Cognitive Behavioral Therapy) before bariatric surgery
    Arm Title
    Post-Op CBT
    Arm Type
    Active Comparator
    Arm Description
    This group will receive CBT (Telephone Based Cognitive Behavioral Therapy) after bariatric surgery
    Intervention Type
    Behavioral
    Intervention Name(s)
    Telephone Based Cognitive Behavioral Therapy
    Other Intervention Name(s)
    Tele-CBT
    Intervention Description
    6 sessions of Cognitive Behavioral Therapy (CBT), lasting approximately 60 minutes each.
    Primary Outcome Measure Information:
    Title
    Changes in Depression severity
    Description
    Measured with "Patient Health Questionnaire" (PHQ-9),a 9-item self-report measure of depression severity
    Time Frame
    Baseline, weekly up to 6 weeks and post-intervention, 6 months and 1 year after bariatric surgery
    Title
    Changes in Anxiety severity
    Description
    Measured by "Generalized Anxiety Disorder Questionnaire" (GAD-7) ,a 7-item self report measure of anxiety severity
    Time Frame
    Baseline, post-intervention, 6 months, and one year after bariatric surgery
    Title
    Changes in Health-related quality of life
    Description
    Measured by "Short-Form Health Survey" (SF-36), a 36-item self-report measure of health-related quality of life.
    Time Frame
    Baseline, post-intervention, 6 months, and one year after bariatric surgery
    Title
    Changes in eating pathology
    Description
    Measured by the "Binge Eating Scale" (BES) and "Emotional Eating Scale" (EES). The BES is a 16-item self-report measure designed specifically for use with obese individuals that assesses binge eating behaviors as well as associated cognitions and emotions. The EES is a 25-item self-report measure that assesses the tendency to cope with negative affect by eating.
    Time Frame
    Baseline, post-intervention, 6 months, and 1 year after bariatric surgery
    Secondary Outcome Measure Information:
    Title
    Comparing improvements on the outcome of Tele-CBT before and after bariatric surgery
    Description
    Half the subjects will receive the CBT intervention prior to surgery, and half will receive it after surgery; they will be followed until 1 year post surgery.
    Time Frame
    One year follow-up

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Fluent in English Have access to telephone and computer with internet access Have the capacity to provide informed consent Exclusion Criteria: Active suicidal ideation Serious mental illness Active severe depression Active severe anxiety Active post traumatic stress disorder
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Sagar V Parikh, MD, FRCPC
    Organizational Affiliation
    University Health Network, Toronto
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Raed Hawa, MD,
    Organizational Affiliation
    University Health Network, Toronto
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Stephanie Cassin, MD
    Organizational Affiliation
    University Health Network, Toronto
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Susan Wnuk, MD
    Organizational Affiliation
    University Health Network, Toronto
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Rachel Strimas
    Organizational Affiliation
    University Health Network, Toronto
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Sanjeev Sockalingam, MD,FRCPC
    Organizational Affiliation
    University Health Network, Toronto
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    Citation
    Cassin SE; Sockalingam S; Wnuk S; Strimas R; Royal S; Hawa, R; & Parikh S. Cognitive behavioural therapy for bariatric surgery patients: Preliminary evidence for feasibility, acceptability, and effectiveness. Cognitive and Behavioral Practice 20: 529-543, 2013.
    Results Reference
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    Telephone-based Cognitive Behavioral Therapy for Bariatric Surgery Patients: A Pilot Study

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