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

Telephone-Based Cognitive Behavioural Therapy for Bariatric Surgery Patients One Year Following Bariatric Surgery: A Pilot Study

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.

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Behavioral: Telephone based Cognitive Behavioral Therapy

Detailed Description

Obesity is an increasingly prevalent chronic condition (Ogden et al., 2006) which is associated with significant health consequences, including type 2 diabetes, obstructive sleep apnea, hypertension, and hyperlipidemia (Bray, 2004). Bariatric surgery is the most effective treatment for patients with extreme obesity (Colquitt et al., 2005). Unfortunately, it has been estimated that 20 to 50% of patients begin to regain their weight within the first 1 ½ to 2 years, and improvements in medical comorbidities dissipate with weight regain (Hsu et al., 1998; Shah et al., 2006). In light of the high relapse rates following bariatric surgery, research on non-surgical factors that influence the outcome of bariatric surgery, such as psychiatric comorbidity, has become increasingly important (Hsu et al., 1998). Up to 55% of bariatric surgery candidates have an Axis I disorder at the time of the initial assessment, with the most common diagnoses being eating disorders (37%), affective disorders (32%), and anxiety disorders (15%) (Muhlhans et al., 2009). Despite accumulating evidence indicating that psychiatric comorbidity is associated with poorer surgical outcomes, psychological interventions are not routinely offered in Bariatric Surgery programs. It has been suggested that cognitive behavioural therapy (CBT) could be helpful in maintaining weight loss (Kalarchian & Marcus, 2003). We have published a paper on the feasibility of the protocol using a small sample and producing promising eating improvements post-intervention (Cassin et al., 2013). A more recent study (Cassin et al., 2016) of the first phase of this study with Tele-CBT delivered 6 months before surgery indicated significant improvements in binge eating, emotional eating, and depressive symptoms, compared to a control group. These results are similar to other studies employing CBT for bariatric surgery patients (e.g. Gade et al., 2014). We have recently published on the outcomes for Tele-CBT delivered 6 months post-surgery (Sockalingam, Cassin, Wnuk, Du, Jackson, Hawa, & Parikh, 2016) that showed significant reductions in scores of binge eating, emotional eating, depression, and anxiety. The same measures used in the first phase of the study (Cassin et al., 2016; Sockalingam et al., 2016) will be used in this second phase, looking at Tele-CBT delivered to patients at one year after surgery. Comparisons between the efficacy of Tele-CBT based on responses to measures will be made for participants receiving the intervention at 6 months before surgery, 6 months after surgery, and 1 year after surgery.

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5T 2S8
      • Toronto Western Hospital with the University Health Network

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. Active suicidal ideation.
2. Active serious mental illness
3. Active severe depression
4. Active severe anxiety
5. Active symptoms of post-traumatic stress disorder

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: One year post-op Tele-CBT; This group will receive Telephone based Cognitive Behavioral Therapy (Tele-CBT) one year after bariatric surgery.	Behavioral: Telephone based Cognitive Behavioral Therapy; 6 sessions of Telephone based Cognitive Behavioral Therapy over the telephone, lasting approximately 60 minutes each.; Other Names: Tele-CBT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Satisfaction with Therapy: Working Alliance Inventory - Short Form (WAI-SF)	12-item self-report measure that assesses the alliance between patient and therapist.	Weekly up to 6 weeks during intervention and immediately post-intervention
Changes in Depression Severity	Measured with Patient Health Questionnaire (PHQ-9), a 9-item self-report measure of depression severity.	Baseline pre-intervention, weekly up to 6 weeks during intervention, immediately post-intervention, and 1 year after intervention
Changes in Anxiety Severity	Measured with Generalized Anxiety Disorder Questionnaire (GAD-7), a 7-item self-report measure of anxiety severity.	Baseline pre-intervention, immediately post-intervention, and 1 year after intervention
Changes in Health-Related Quality of Life	Measured with Short-Form Health Survey (SF-36), a 36-item self-report measure of health-related quality of life.	Baseline pre-intervention, immediately post-intervention, and 1 year after intervention
Satisfaction with Therapy: Tele-CBT Client Change Interview	a 9-item self-report measure that qualitatively assesses patient experience with the Tele-CBT treatment	Weekly up to 6 weeks during intervention, immediately post-intervention, 1 year after intervention
Satisfaction with Therapy: Helpful Aspects of Therapy Form (HAT)	brief, open-ended questionnaire completed by participants after each session. Participants are asked to describe in their own words the most helpful event in the session, and to rate how helpful it was.	Weekly up to 6 weeks during intervention and immediately post-intervention

Collaborators and Investigators

• Sponsor: University Health Network, Toronto
• Investigators: Principal Investigator: Sanjeev Sockalingam, MD, FRCPC, University of Toronto, Toronto Western Hospital; Principal Investigator: Stephanie E Cassin, PhD, CPsych, Ryerson University; Study Director: 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

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2014
• Primary Completion (Actual): December 1, 2017
• Study Completion (Actual): March 1, 2018

Study Registration Dates

• First Submitted: September 8, 2016
• First Submitted That Met QC Criteria: September 28, 2016
• First Posted (Estimate): September 30, 2016

Study Record Updates

• Last Update Posted (Actual): May 2, 2018
• Last Update Submitted That Met QC Criteria: April 30, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: Obesity; Bariatric Surgery; Cognitive Therapy; Bariatrics; Binge eating
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity
• Other Study ID Numbers: 11-0622-BE2; Grant #317877 (Other Grant/Funding Number: Canadian Institutes of Health Research (CIHR))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data (IPD) will not be shared publicly in order to protect patient confidentiality. Aggregate and anonymous data will be shared in peer-reviewed journal articles and scientific presentations.