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

This study is not yet open for participant recruitment.
Verified January 2012 by University Health Network, Toronto
Sponsor:
Information provided by:
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT01508585
First received: December 22, 2011
Last updated: January 9, 2012
Last verified: January 2012
History of Changes

December 22, 2011
January 9, 2012
February 2012
June 2013   (final data collection date for primary outcome measure)
  • Changes in Depression severity [ Time Frame: Baseline, weekly up to 6 weeks and 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 and with in 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, 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 psychopathology of eating disorder [ Time Frame: Baseline ,6 months and 1 year after bariatric surgery ] [ Designated as safety issue: No ]
    measured by "Eating Disorder Examination Questionnaire" (EDE-Q), a 41-item self-report measure that assesses the psychopathology associated with the diagnosis of an eating disorder.
Same as current
Complete list of historical versions of study NCT01508585 on ClinicalTrials.gov Archive Site
comparing improvement on the outcome of Tele-CBT before and after the bariatric surgery [ Time Frame: One year follow-up ] [ Designated as safety issue: No ]
Half the subjects will received the CBT intervention prior to surgery, and half will receive it after surgery; they will be followed until 1 year post surgery.
Same as current
Not Provided
Not Provided
 
Telephone-based Cognitive Behavioral Therapy for Bariatric Surgery Patients: A Pilot Study
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.

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 Tel-CBT as an adjunctive treatment to the usual standard of care in bariatric surgery patients.
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Obesity
  • Eating Disorder
Behavioral: Telephone based Cognitive Behavioral therapy
6 session of Cognitive Behavioral Therapy (CBT), lasting approximately 60 minutes each.
Other Name: (Tele-CBT)
  • Active Comparator: Pre -Op CBT
    This group will receive CBT before bariatric surgery
    Intervention: Behavioral: Telephone based Cognitive Behavioral therapy
  • Active Comparator: post-Op CBT
    This group will receive CBT after bariatric surgery
    Intervention: Behavioral: Telephone based Cognitive Behavioral therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
60
June 2013
June 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Sagar Parikh, MD, FRCPC 416-603-5734 sagar.parikh@uhn.on.ca
Not Provided
 
NCT01508585
11-0622-BE
No
Not Provided
University Health Network, Toronto
Not Provided
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
University Health Network, Toronto
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP