Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

December 22, 2011
July 14, 2015
March 2012
December 2014   (final data collection date for primary outcome measure)
  • 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.
  • 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.
Complete list of historical versions of study NCT01508585 on ClinicalTrials.gov Archive Site
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.
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.
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 Tele-CBT as an adjunctive treatment to the usual standard of care in bariatric surgery patients.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Obesity
  • Eating Disorder
Behavioral: Telephone Based Cognitive Behavioral Therapy
6 sessions of Cognitive Behavioral Therapy (CBT), lasting approximately 60 minutes each.
Other Name: Tele-CBT
  • Active Comparator: Pre-Op CBT
    This group will receive CBT (Telephone Based Cognitive Behavioral Therapy) before bariatric surgery
    Intervention: Behavioral: Telephone Based Cognitive Behavioral Therapy
  • Active Comparator: Post-Op CBT
    This group will receive CBT (Telephone Based Cognitive Behavioral Therapy) after bariatric surgery
    Intervention: Behavioral: Telephone Based Cognitive Behavioral Therapy
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
47
December 2014
December 2014   (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   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01508585
11-0622-BE
No
Not Provided
Not Provided
University Health Network, Toronto
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
July 2015

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