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

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Eating Disorder
• Intervention / Treatment: Behavioral: Telephone Based Cognitive Behavioral Therapy

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 Type: Interventional
• Enrollment (Actual): 47
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Health Network, Toronto
• Investigators: 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

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: December 22, 2011
• First Submitted That Met QC Criteria: January 9, 2012
• First Posted (Estimate): January 12, 2012

Study Record Updates

• Last Update Posted (Estimate): July 16, 2015
• Last Update Submitted That Met QC Criteria: July 14, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Keywords: Obesity; Bariatric surgery; Cognitive Behavioral Therapy; Telephone based CBT
• Additional Relevant MeSH Terms: Mental Disorders; Feeding and Eating Disorders
• Other Study ID Numbers: 11-0622-BE