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
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
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
NCT ID
NCT01508585
First Posted
December 22, 2011
Last Updated
July 14, 2015
Sponsor
University Health Network, Toronto
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
background
Learn more about this trial
Telephone-based Cognitive Behavioral Therapy for Bariatric Surgery Patients: A Pilot Study
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