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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Obesity, Eating Disorder

Intervention / Treatment
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* Behavioral: Telephone Based Cognitive Behavioral Therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Pre-Op CBT<br>This group will receive CBT (Telephone Based Cognitive Behavioral Therapy) before bariatric surgery | Behavioral: Telephone Based Cognitive Behavioral Therapy<br>* 6 sessions of Cognitive Behavioral Therapy (CBT), lasting approximately 60 minutes each.<br>* Other names: Tele-CBT;|
| Active Comparator: Post-Op CBT<br>This group will receive CBT (Telephone Based Cognitive Behavioral Therapy) after bariatric surgery | Behavioral: Telephone Based Cognitive Behavioral Therapy<br>* 6 sessions of Cognitive Behavioral Therapy (CBT), lasting approximately 60 minutes each.<br>* Other names: Tele-CBT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Depression severity | Measured with Patient Health Questionnaire (PHQ-9),a 9-item self-report measure of depression severity | Baseline, weekly up to 6 weeks and post-intervention, 6 months and 1 year after bariatric surgery | 
| Changes in Anxiety severity | Measured by Generalized Anxiety Disorder Questionnaire (GAD-7) ,a 7-item self report measure of anxiety severity | Baseline, post-intervention, 6 months, and one year after bariatric surgery | 
| 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. | Baseline, post-intervention, 6 months, and one year after bariatric surgery | 
| 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. | Baseline, post-intervention, 6 months, and 1 year after bariatric surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | One year follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bariatric surgery, Cognitive Behavioral Therapy, Telephone based CBT, Obesity