Tele-CBT Following Bariatric Surgery: Randomized Control Trial

NCT03315247 | Completed DMC

• 2 other identifiers: 17-5655376045
• Study Type: interventional
• Target: 306
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Obesity; Bariatric Surgery; Bariatrics; Cognitive Therapy; Binge Eating

Outcome Measures

Primary Outcomes (1)

• Change in Weight

  Change in weight measured in kg

  1.25, 1.5, 2, 3 years post-surgery

Secondary Outcomes (9)

• Changes in obesity-related medical comorbidities - Medication Burden

  2 and 3 years post-surgery

• Changes in obesity-related medical comorbidities - Medical Treatments

  2 and 3 years post-surgery

• Changes in obesity-related medical comorbidities - T2DM

  2 and 3 years post-surgery

• Changes in eating pathology - Emotional Eating

  1.25, 1.5, 2, and 3 years post-surgery

• Changes in eating pathology - Binge Eating

  1.25, 1.5, 2, and 3 years post-surgery

Study Arms (2)

Treatment as Usual

NO INTERVENTION

Participants assigned to the Treatment as Usual group will attend routine clinic visits at the Toronto Western Hospital Bariatrics Surgery Program (TWH-BSP). These visits generally include education on bariatric surgery and nutrition. Patients meet with select members of the multidisciplinary team at 1, 2, and 3 years post-surgery, and may attend an optional monthly support group. Participants' service utilization (i.e., attendance at optional sessions) will be documented and compared across groups.

Telephone-Based CBT

EXPERIMENTAL

The Tele-CBT intervention will be delivered 1 year following bariatric surgery. Participants will receive 6 weekly Telephone-based Cognitive Behavioural Therapy sessions and 1 final "booster" session 1 month later, all approximately 55-minutes in duration and scheduled at a time convenient for the participants.

Behavioral: Telephone-Based CBT

Interventions

Telephone-Based CBT BEHAVIORAL

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.

Also known as: Tele-CBT

Telephone-Based CBT

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Received bariatric surgery 1 year ago
• Fluent in English
• Have Internet access to complete online questionnaires.

You may not qualify if:

• Current active suicidal ideation
• Current poorly controlled psychiatric illness that would render Tele-CBT very difficult, including serious mental illness (i.e., psychotic disorder, bipolar disorder), severe depression (i.e., current major depressive episode diagnosis and Patient Health Questionnaire \[PHQ-9\]61 score \> 20), or severe anxiety (i.e., current anxiety disorder diagnosis and Generalized Anxiety Disorder \[GAD-7\]62 score \>15)
• Current poorly controlled medical illness that would render Tele-CBT very difficult.

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Toronto Western Hospital

Toronto, Ontario, M5T2S8, Canada

Location

Related Publications (7)

• Meany G, Conceicao E, Mitchell JE. Binge eating, binge eating disorder and loss of control eating: effects on weight outcomes after bariatric surgery. Eur Eat Disord Rev. 2014 Mar;22(2):87-91. doi: 10.1002/erv.2273.

  PMID: 24347539 BACKGROUND

• Sheets CS, Peat CM, Berg KC, White EK, Bocchieri-Ricciardi L, Chen EY, Mitchell JE. Post-operative psychosocial predictors of outcome in bariatric surgery. Obes Surg. 2015 Feb;25(2):330-45. doi: 10.1007/s11695-014-1490-9.

  PMID: 25381119 BACKGROUND

• DiGiorgi M, Rosen DJ, Choi JJ, Milone L, Schrope B, Olivero-Rivera L, Restuccia N, Yuen S, Fisk M, Inabnet WB, Bessler M. Re-emergence of diabetes after gastric bypass in patients with mid- to long-term follow-up. Surg Obes Relat Dis. 2010 May-Jun;6(3):249-53. doi: 10.1016/j.soard.2009.09.019. Epub 2009 Oct 29.

  PMID: 20510288 BACKGROUND

• Shah M, Simha V, Garg A. Review: long-term impact of bariatric surgery on body weight, comorbidities, and nutritional status. J Clin Endocrinol Metab. 2006 Nov;91(11):4223-31. doi: 10.1210/jc.2006-0557. Epub 2006 Sep 5.

  PMID: 16954156 BACKGROUND

• Cassin SE, Park KE, Leung SE, Ma C, Tomlinson G, Hawa R, Wnuk S, Jackson T, Urbach D, Okrainec A, Brown J, Sandre D, Sockalingam S. A Randomized-Controlled Trial Examining Telephone-Based Cognitive Behavioral Therapy for Patients After Metabolic and Bariatric Surgery: 18 Month Follow-up Results. Obes Surg. 2025 Oct;35(10):4103-4113. doi: 10.1007/s11695-025-08163-2. Epub 2025 Sep 1.

  PMID: 40887513 DERIVED

• Sockalingam S, Leung SE, Ma C, Tomlinson G, Hawa R, Wnuk S, Jackson T, Urbach D, Okrainec A, Brown J, Sandre D, Cassin SE. Efficacy of Telephone-Based Cognitive Behavioral Therapy for Weight Loss, Disordered Eating, and Psychological Distress After Bariatric Surgery: A Randomized Clinical Trial. JAMA Netw Open. 2023 Aug 1;6(8):e2327099. doi: 10.1001/jamanetworkopen.2023.27099.

  PMID: 37535357 DERIVED

• Sockalingam S, Leung SE, Ma C, Hawa R, Wnuk S, Dash S, Jackson T, Cassin SE. The Impact of Telephone-Based Cognitive Behavioral Therapy on Mental Health Distress and Disordered Eating Among Bariatric Surgery Patients During COVID-19: Preliminary Results from a Multisite Randomized Controlled Trial. Obes Surg. 2022 Jun;32(6):1884-1894. doi: 10.1007/s11695-022-05981-6. Epub 2022 Feb 25.

  PMID: 35218006 DERIVED

MeSH Terms

Conditions

Obesity; Bulimia

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperphagia; Signs and Symptoms, Digestive

Study Officials

• Sanjeev Sockalingam, MD, FRCPC

  University of Toronto, University Health Network

  PRINCIPAL INVESTIGATOR

• Stephanie Cassin, PhD, CPsych

  Toronto Metropolitan University

  PRINCIPAL INVESTIGATOR

• Raed Hawa, MD, FRCPC

  University of Toronto, University Health Network

  STUDY DIRECTOR

• Susan Wnuk, PhD, CPsych

  University of Toronto, University Health Network

  STUDY DIRECTOR

• Timothy Jackson, MD, FRCPC

  University of Toronto, University Health Network

  STUDY DIRECTOR

• Lorraine Lipscombe, MD, FRCPC

  Women's College Hospital

  STUDY DIRECTOR

• Allan Okrainec, MD, FRCPC

  University of Toronto, University Health Network

  STUDY DIRECTOR

• George Tomlinson, PhD

  University of Toronto

  STUDY DIRECTOR

• David Urbach, MD, FRCPC

  University of Toronto, University Health Network

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Psychiatrist-in-Chief

Model Details: Randomized Control Trial

Study Record Dates

• First Submitted: August 31, 2017
• First Posted: October 20, 2017
• Study Start: February 9, 2018
• Primary Completion: January 15, 2024
• Study Completion: January 15, 2024
• Last Updated: May 10, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)