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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01508585
• Other study ID #: 11-0622-BE
• Status: Completed
• Phase: N/A
• First received: December 22, 2011
• Last updated: July 14, 2015
• Start date: March 2012
• Est. completion date: December 2014

Study information

• Verified date: July 2015
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Eating Disorder
• Eating Disorders
• Obesity

Intervention

Behavioral:
• Telephone Based Cognitive Behavioral Therapy
6 sessions of Cognitive Behavioral Therapy (CBT), lasting approximately 60 minutes each.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

References & Publications (1)

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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	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	No