Tele-CBT One Year Following Bariatric Surgery: A Pilot Study

NCT02920112 | Completed

• 2 other identifiers: 11-0622-BE2Grant #317877
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

This second phase of a pilot study (non-drug) will examine the effectiveness and feasibility of Telephone based Cognitive Behavioural Therapy (Tele-CBT) as an additional treatment to the usual standard of care in bariatric surgery patients. Participants one year post-surgery will receive six sessions of Tele-CBT and complete measures before, during, immediately after, and one year after participation in the study.

Conditions

Obesity

Keywords

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

Outcome Measures

Primary Outcomes (4)

• Changes in Eating Pathology: Emotional Eating Scale (EES)

  25-item self-report measure that assesses tendency to cope with negative affect by eating.

  Baseline pre-intervention, weekly up to 6 weeks during intervention, immediately post-intervention, and 1 year after intervention,

• Changes in Eating Pathology: Binge Eating Scale (BES)

  Baseline pre-intervention, immediately post-intervention, and 1 year after intervention

• Changes in Eating Pathology: Eating Disorder Examination Questionnaire (EDEQ)

  41-item self-report measure that assesses eating disorder psychopathology. Only 3 items regarding binge eating will be used. Will be used to measure changes in eating pathology.

  Baseline pre-intervention, immediately post-intervention, and 1 year after intervention

• Changes in Eating Pathology: Ontario Bariatric Eating Self-Efficacy Scale (OBESE) - Changes in Eating Pathology

  28-item self-report measure of eating self-efficacy in bariatric patients.

  Baseline pre-intervention, immediately post-intervention, and 1 year after intervention

Secondary Outcomes (6)

• Satisfaction with Therapy: Working Alliance Inventory - Short Form (WAI-SF)

  Weekly up to 6 weeks during intervention and immediately post-intervention

• Changes in Depression Severity

  Baseline pre-intervention, weekly up to 6 weeks during intervention, immediately post-intervention, and 1 year after intervention

• Changes in Anxiety Severity

  Baseline pre-intervention, immediately post-intervention, and 1 year after intervention

• Changes in Health-Related Quality of Life

  Baseline pre-intervention, immediately post-intervention, and 1 year after intervention

• Satisfaction with Therapy: Tele-CBT Client Change Interview

  Weekly up to 6 weeks during intervention, immediately post-intervention, 1 year after intervention

Study Arms (1)

One year post-op Tele-CBT

EXPERIMENTAL

This group will receive Telephone based Cognitive Behavioral Therapy (Tele-CBT) one year after bariatric surgery.

Behavioral: Telephone based Cognitive Behavioral Therapy

Interventions

Telephone based Cognitive Behavioral Therapy BEHAVIORAL

6 sessions of Telephone based Cognitive Behavioral Therapy over the telephone, lasting approximately 60 minutes each.

Also known as: Tele-CBT

One year post-op Tele-CBT

Eligibility Criteria

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

You may qualify if:

• Fluent in English.
• Have access to a telephone and a computer with internet connection.
• Have the capacity to provide informed consent.
• Patient is at approximately one year post-surgery at the Bariatric Surgery Program at Toronto Western Hospital.

You may not qualify if:

• Active suicidal ideation.
• Active serious mental illness
• Active severe depression
• Active severe anxiety
• Active symptoms of post-traumatic stress disorder

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Toronto Western Hospital with the University Health Network

Toronto, Ontario, M5T 2S8, Canada

Location

Related Publications (5)

• Cassin SE, Sockalingam S, Du C, Wnuk S, Hawa R, Parikh SV. A pilot randomized controlled trial of telephone-based cognitive behavioural therapy for preoperative bariatric surgery patients. Behav Res Ther. 2016 May;80:17-22. doi: 10.1016/j.brat.2016.03.001. Epub 2016 Mar 10.

  PMID: 26990279 BACKGROUND

• Cassin SE, Sockalingam S, Wnuk S, Strimas R, Royal S, Hawa R, Parikh SV. Cognitive Behavioral Therapy for Bariatric Surgery Patients: Preliminary Evidence for Feasibility, Acceptability, and Effectiveness. Cognitive and Behavioral Practice 20(4): 529-543, 2013.

  BACKGROUND

• Sockalingam S, Cassin SE, Wnuk S, Du C, Jackson T, Hawa R, Parikh SV. A Pilot Study on Telephone Cognitive Behavioral Therapy for Patients Six-Months Post-Bariatric Surgery. Obes Surg. 2017 Mar;27(3):670-675. doi: 10.1007/s11695-016-2322-x.

  PMID: 27491293 BACKGROUND

• Santiago VA, Cassin SE, Wnuk S, Du C, Hawa R, Parikh SV, Sockalingam S. "If you're offered help, take it": A qualitative study examining bariatric patients' experience of telephone-based cognitive behavioural therapy. Clin Obes. 2021 Apr;11(2):e12431. doi: 10.1111/cob.12431. Epub 2020 Nov 29.

  PMID: 33251753 DERIVED

• Sockalingam S, Leung SE, Hawa R, Wnuk S, Parikh SV, Jackson T, Cassin SE. Telephone-based cognitive behavioural therapy for female patients 1-year post-bariatric surgery: A pilot study. Obes Res Clin Pract. 2019 Sep-Oct;13(5):499-504. doi: 10.1016/j.orcp.2019.07.003. Epub 2019 Aug 10.

  PMID: 31409544 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, Toronto Western Hospital

  PRINCIPAL INVESTIGATOR

• Stephanie E Cassin, PhD, CPsych

  Toronto Metropolitan University

  PRINCIPAL INVESTIGATOR

• Raed Hawa, MD, FRCPC

  University of Toronto, Toronto Western Hospital

  STUDY DIRECTOR

• Susan Wnuk, PhD, CPsych

  University of Toronto, Toronto Western Hospital

  STUDY DIRECTOR

• Timothy Jackson, MD, FRCSC

  University of Toronto, Toronto Western Hospital

  STUDY DIRECTOR

• Chau Du, MSc

  University Health Network, Toronto

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: September 8, 2016
• First Posted: September 30, 2016
• Study Start: May 1, 2014
• Primary Completion: December 1, 2017
• Study Completion: March 1, 2018
• Last Updated: May 2, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)