Tele-CBT Following Bariatric Surgery: Randomized Control Trial

Summary

Bariatric (weight loss) surgery is the most effective treatment for extreme obesity, but surgery does not treat underlying psychological and behavioural issues. Currently, psychotherapy ("talk therapy") for eating problems is not routinely offered with surgery, and many people start to regain weight one year later. Objective: This study will examine if adding a convenient and accessible psychotherapy by phone one year after surgery will lead to increased weight loss two years after surgery. Primary Hypothesis: Relative to the Control group (who will get routine care), the group of individuals who get psychotherapy will have lower weights 2 years after surgery. Secondary Hypotheses: Relative to the Control group, the psychotherapy group will report significantly less maladaptive eating behaviours and medical burden, and significantly greater quality of life. Method: Participants recruited from the Bariatric Surgery Programs at Toronto Western Hospital will be randomly assigned to 1 of 2 groups: 1) Control (Usual Standard of Care) or 2) Tele-CBT (a 7-session telephone-based cognitive behavioural therapy \[a type of "talk therapy"\] intervention focused on developing coping skills to improve maladaptive thoughts, emotions, and eating behaviours, specifically designed for bariatric surgery patients, delivered 1 year post-surgery). They will have their weight measured and will complete measures of eating behaviour and quality of life prior to the intervention, and again at several time points extending to 2 years post-surgery. Implications: If Telephone-Cognitive Behavioural Therapy (CBT) is found to improve bariatric surgery outcomes, it could become the standard of care in Canadian bariatric surgery programs and beyond, and be routinely offered to patients who cannot feasibly attend CBT sessions due to physical or practical barriers.

Conditions

• Obesity

Interventions

BEHAVIORAL

Telephone-Based CBT

The Tele-CBT sessions focus on introducing the cognitive behavioural model of overeating and obesity, scheduling healthy meals and snacks at regular time intervals and recording consumption using food records, scheduling pleasurable alternative activities to overeating, identifying and planning for difficult eating scenarios, and reducing vulnerability to overeating by solving problems and challenging negative thoughts. Participants are expected to complete CBT homework between sessions, such as completing food records, engaging in pleasurable and self-care activities, and completing a variety of worksheets.

Sponsors & Collaborators

• University Health Network, Toronto

  lead OTHER

Principal Investigators

• Sanjeev Sockalingam, MD, FRCPC · University of Toronto, University Health Network

• Stephanie Cassin, PhD, CPsych · Toronto Metropolitan University

• Raed Hawa, MD, FRCPC · University of Toronto, University Health Network

• Susan Wnuk, PhD, CPsych · University of Toronto, University Health Network

• Timothy Jackson, MD, FRCPC · University of Toronto, University Health Network

• Lorraine Lipscombe, MD, FRCPC · Women's College Hospital

• Allan Okrainec, MD, FRCPC · University of Toronto, University Health Network

• George Tomlinson, PhD · University of Toronto

• David Urbach, MD, FRCPC · University of Toronto, University Health Network

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-02-09

Primary Completion

2024-01-15

Completion

2024-01-15

Countries

• Canada

Study Locations