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

NCT01508585 | Completed

• 1 other identifier: 11-0622-BE
• Study Type: interventional
• Target: 47
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Obesity; Eating Disorder

Keywords

Bariatric surgery; Cognitive Behavioral Therapy; Telephone based CBT; Obesity

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

• Comparing improvements on the outcome of Tele-CBT before and after bariatric surgery

  One year follow-up

Study Arms (2)

Pre-Op CBT

ACTIVE COMPARATOR

This group will receive CBT (Telephone Based Cognitive Behavioral Therapy) before bariatric surgery

Behavioral: Telephone Based Cognitive Behavioral Therapy

Post-Op CBT

ACTIVE COMPARATOR

This group will receive CBT (Telephone Based Cognitive Behavioral Therapy) after bariatric surgery

Behavioral: Telephone Based Cognitive Behavioral Therapy

Interventions

Telephone Based Cognitive Behavioral Therapy BEHAVIORAL

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

Also known as: Tele-CBT

Post-Op CBT; Pre-Op CBT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University Health Network, Toronto: lead

Related 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.

  BACKGROUND

MeSH Terms

Conditions

Obesity; Feeding and Eating Disorders

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive; Mental Disorders

Study Officials

• Sagar V Parikh, MD, FRCPC

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

• 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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2011
• First Posted: January 12, 2012
• Study Start: March 1, 2012
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: July 16, 2015

Record last verified: 2015-07