Telephone-based Cognitive Behavioral Therapy for Bariatric Surgery Patients: A Pilot Study
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Obesity Eating Disorder |
Behavioral: Telephone based Cognitive Behavioral therapy |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Telephone-based Cognitive Behavioral Therapy for Bariatric Surgery Patients: A Pilot Study |
- Changes in Depression severity [ Time Frame: Baseline, weekly up to 6 weeks and 6 months and 1 year after bariatric surgery ] [ Designated as safety issue: No ]measured with "Patient Health Questionnaire" (PHQ-9),a 9-item self-report measure of depression severity
- Changes in Anxiety severity [ Time Frame: Baseline and with in 6 months and one year after bariatric surgery ] [ Designated as safety issue: No ]measured by "Generalized Anxiety Disorder Questionnaire" (GAD-7) ,a 7-item self report measure of anxiety severity
- Changes in Health-related quality of life [ Time Frame: baseline, 6 months and one year after bariatric surgery ] [ Designated as safety issue: No ]measured by "Short-Form Health Survey" (SF-36), a 36-item self-report measure of health-related quality of life.
- changes in psychopathology of eating disorder [ Time Frame: Baseline ,6 months and 1 year after bariatric surgery ] [ Designated as safety issue: No ]measured by "Eating Disorder Examination Questionnaire" (EDE-Q), a 41-item self-report measure that assesses the psychopathology associated with the diagnosis of an eating disorder.
- comparing improvement on the outcome of Tele-CBT before and after the bariatric surgery [ Time Frame: One year follow-up ] [ Designated as safety issue: No ]Half the subjects will received the CBT intervention prior to surgery, and half will receive it after surgery; they will be followed until 1 year post surgery.
| Estimated Enrollment: | 60 |
| Study Start Date: | February 2012 |
| Estimated Study Completion Date: | June 2013 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Pre -Op CBT
This group will receive CBT before bariatric surgery
|
Behavioral: Telephone based Cognitive Behavioral therapy
6 session of Cognitive Behavioral Therapy (CBT), lasting approximately 60 minutes each.
Other Name: (Tele-CBT)
|
|
Active Comparator: post-Op CBT
This group will receive CBT after bariatric surgery
|
Behavioral: Telephone based Cognitive Behavioral therapy
6 session of Cognitive Behavioral Therapy (CBT), lasting approximately 60 minutes each.
Other Name: (Tele-CBT)
|
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 Tel-CBT as an adjunctive treatment to the usual standard of care in bariatric surgery patients.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: Sagar Parikh, MD, FRCPC | 416-603-5734 | sagar.parikh@uhn.on.ca |
| Principal Investigator: | Sagar V Parikh, MD, FRCPC | University Health Network, Toronto |
| Study Director: | Raed Hawa, MD, | University Health Network, Toronto |
| Study Director: | Stephanie Cassin, MD | University Health Network, Toronto |
| Study Director: | Susan Wnuk, MD | University Health Network, Toronto |
| Study Director: | Rachel Strimas | University Health Network, Toronto |
| Study Director: | Sanjeev Sockalingam, MD,FRCPC | University Health Network, Toronto |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT01508585 History of Changes |
| Other Study ID Numbers: | 11-0622-BE |
| Study First Received: | December 22, 2011 |
| Last Updated: | January 9, 2012 |
| Health Authority: | Canada: Ethics Review Committee |
Keywords provided by University Health Network, Toronto:
|
Bariatric surgery Cognitive Behavioral Therapy Telephone based CBT Obesity |
Additional relevant MeSH terms:
|
Eating Disorders Obesity Mental Disorders Overnutrition |
Nutrition Disorders Overweight Body Weight Signs and Symptoms |
ClinicalTrials.gov processed this record on May 23, 2013