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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT01508585
First received: December 22, 2011
Last updated: July 14, 2015
Last verified: July 2015
  Purpose

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 Intervention
Obesity
Eating Disorder
Behavioral: Telephone Based Cognitive Behavioral Therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Telephone-based Cognitive Behavioral Therapy for Bariatric Surgery Patients: A Pilot Study

Resource links provided by NLM:


Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • Changes in Depression severity [ Time Frame: Baseline, weekly up to 6 weeks and post-intervention, 6 months and 1 year after bariatric surgery ] [ Designated as safety issue: No ]
    Measured with "Patient Health Questionnaire" (PHQ-9),a 9-item self-report measure of depression severity

  • Changes in Anxiety severity [ Time Frame: Baseline, post-intervention, 6 months, and one year after bariatric surgery ] [ Designated as safety issue: No ]
    Measured by "Generalized Anxiety Disorder Questionnaire" (GAD-7) ,a 7-item self report measure of anxiety severity

  • Changes in Health-related quality of life [ Time Frame: Baseline, post-intervention, 6 months, and one year after bariatric surgery ] [ Designated as safety issue: No ]
    Measured by "Short-Form Health Survey" (SF-36), a 36-item self-report measure of health-related quality of life.

  • Changes in eating pathology [ Time Frame: Baseline, post-intervention, 6 months, and 1 year after bariatric surgery ] [ Designated as safety issue: No ]
    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 [ Time Frame: One year follow-up ] [ Designated as safety issue: No ]
    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.


Enrollment: 47
Study Start Date: March 2012
Study Completion Date: December 2014
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Tele-CBT

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01508585

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
  More Information

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.

Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT01508585     History of Changes
Other Study ID Numbers: 11-0622-BE
Study First Received: December 22, 2011
Last Updated: July 14, 2015
Health Authority: Canada: Ethics Review Committee

Keywords provided by University Health Network, Toronto:
Bariatric surgery
Cognitive Behavioral Therapy
Telephone based CBT
Obesity

Additional relevant MeSH terms:
Eating Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 01, 2015