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Completed

NCT Number: NCT01508585

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.

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Key information

Conditions

Obesity Body Weight Eating Disorder Feeding and Eating Disorders Mental Disorders Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Telephone Based Cognitive Behavioral Therapy

Behavioral

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

Other names: Tele-CBT

Primary outcomes

  1. Changes in Depression severity

    Time frame: Baseline, weekly up to 6 weeks and post-intervention, 6 months and 1 year after bariatric surgery

    Measured with "Patient Health Questionnaire" (PHQ-9),a 9-item self-report measure of depression severity

  2. Changes in Anxiety severity

    Time frame: Baseline, post-intervention, 6 months, and one year after bariatric surgery

    Measured by "Generalized Anxiety Disorder Questionnaire" (GAD-7) ,a 7-item self report measure of anxiety severity

  3. Changes in Health-related quality of life

    Time frame: Baseline, post-intervention, 6 months, and one year after bariatric surgery

    Measured by "Short-Form Health Survey" (SF-36), a 36-item self-report measure of health-related quality of life.

  4. Changes in eating pathology

    Time frame: Baseline, post-intervention, 6 months, and 1 year after bariatric surgery

    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 outcomes

  1. Comparing improvements on the outcome of Tele-CBT before and after bariatric surgery

    Time frame: One year follow-up

    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.

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Jan 12, 2012
Registry last updated
Jul 16, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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