Clinical trial NCT01508585: Telephone-based Cognitive Behavioral Therapy for Bariatric Surgery Patients: A Pilot Study
Official title: Telephone-based Cognitive Behavioral Therapy for Bariatric Surgery Patients: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Eating Disorder
Keywords: Bariatric surgery
Cognitive Behavioral Therapy
Telephone based CBT
Obesity
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2012-01-12
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Changes in Depression severity
timeFrame: Baseline, weekly up to 6 weeks and post-intervention, 6 months and 1 year after bariatric surgery
measure: Changes in Anxiety severity
timeFrame: Baseline, post-intervention, 6 months, and one year after bariatric surgery
measure: Changes in Health-related quality of life
timeFrame: Baseline, post-intervention, 6 months, and one year after bariatric surgery
measure: Changes in eating pathology
timeFrame: Baseline, post-intervention, 6 months, and 1 year after bariatric surgery
Secondary outcomes:
measure: Comparing improvements on the outcome of Tele-CBT before and after bariatric surgery
timeFrame: One year follow-up
Other outcomes:
Locations:
Study officials:
affiliation: University Health Network, Toronto
name: Sagar V Parikh, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
affiliation: University Health Network, Toronto
name: Raed Hawa, MD,
role: STUDY_DIRECTOR
affiliation: University Health Network, Toronto
name: Stephanie Cassin, MD
role: STUDY_DIRECTOR
affiliation: University Health Network, Toronto
name: Susan Wnuk, MD
role: STUDY_DIRECTOR
affiliation: University Health Network, Toronto
name: Rachel Strimas
role: STUDY_DIRECTOR
affiliation: University Health Network, Toronto
name: Sanjeev Sockalingam, MD,FRCPC
role: STUDY_DIRECTOR
References:
citation: 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.