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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01508585
Enrollment
47
Registered
2012-01-12
Start date
2012-03-31
Completion date
2014-12-31
Last updated
2015-07-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Eating Disorder, Obesity

Keywords

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

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.

Interventions

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

Sponsors

University Health Network, Toronto
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Changes in Depression severityBaseline, weekly up to 6 weeks and post-intervention, 6 months and 1 year after bariatric surgeryMeasured with Patient Health Questionnaire (PHQ-9),a 9-item self-report measure of depression severity
Changes in Anxiety severityBaseline, post-intervention, 6 months, and one year after bariatric surgeryMeasured by Generalized Anxiety Disorder Questionnaire (GAD-7) ,a 7-item self report measure of anxiety severity
Changes in Health-related quality of lifeBaseline, post-intervention, 6 months, and one year after bariatric surgeryMeasured by Short-Form Health Survey (SF-36), a 36-item self-report measure of health-related quality of life.
Changes in eating pathologyBaseline, post-intervention, 6 months, and 1 year after bariatric surgeryMeasured 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

MeasureTime frameDescription
Comparing improvements on the outcome of Tele-CBT before and after bariatric surgeryOne year follow-upHalf 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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026