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

Not Applicable

Completed

• Conditions: Obesity; Eating Disorder
• Interventions: Behavioral: Telephone Based Cognitive Behavioral Therapy

• Registration Number: NCT01508585
• Lead Sponsor: University Health Network, Toronto

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.

Study Timeline

• Study First Submitted: 2011-12-22
• Study First Submitted QC: 2012-01-09
• Study First Posted: 2012-01-12
• Study Start: 2012-03
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-14
• Last Update Posted: 2015-07-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 47

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Post-Op CBT	Telephone Based Cognitive Behavioral Therapy	This group will receive CBT (Telephone Based Cognitive Behavioral Therapy) after bariatric surgery
Pre-Op CBT	Telephone Based Cognitive Behavioral Therapy	This group will receive CBT (Telephone Based Cognitive Behavioral Therapy) before bariatric surgery

Primary Outcome Measures

Name	Time	Method
Changes in Depression severity	Baseline, weekly up to 6 weeks and post-intervention, 6 months and 1 year after bariatric surgery	Measured with "Patient Health Questionnaire" (PHQ-9),a 9-item self-report measure of depression severity
Changes in Anxiety severity	Baseline, post-intervention, 6 months, and one year after bariatric surgery	Measured by "Generalized Anxiety Disorder Questionnaire" (GAD-7) ,a 7-item self report measure of anxiety severity
Changes in Health-related quality of life	Baseline, post-intervention, 6 months, and one year after bariatric surgery	Measured by "Short-Form Health Survey" (SF-36), a 36-item self-report measure of health-related quality of life.
Changes in eating pathology	Baseline, post-intervention, 6 months, and 1 year after bariatric surgery	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

Name	Time	Method
Comparing improvements on the outcome of Tele-CBT before and after bariatric surgery	One year follow-up	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.