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

Sponsor

University Health Network, Toronto (Other)

Overall Status

Completed

CT.gov ID

NCT01508585

Collaborator

(none)

Enrollment

Arms

Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Obesity Eating Disorder	Behavioral: Telephone Based Cognitive Behavioral Therapy	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

47 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Mar 1, 2012

Actual Primary Completion Date :

Dec 1, 2014

Actual Study Completion Date :

Dec 1, 2014

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

No locations specified.

Sponsors and Collaborators

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