Clinical trial NCT02920112: Tele-CBT One Year Following Bariatric Surgery: A Pilot Study
Official title: Telephone-Based Cognitive Behavioural Therapy for Bariatric Surgery Patients One Year Following Bariatric Surgery: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Obesity
Bariatric Surgery
Bariatrics
Cognitive Therapy
Binge eating
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2016-09-30
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes in Eating Pathology: Emotional Eating Scale (EES)
timeFrame: Baseline pre-intervention, weekly up to 6 weeks during intervention, immediately post-intervention, and 1 year after intervention,
measure: Changes in Eating Pathology: Binge Eating Scale (BES)
timeFrame: Baseline pre-intervention, immediately post-intervention, and 1 year after intervention
measure: Changes in Eating Pathology: Eating Disorder Examination Questionnaire (EDEQ)
timeFrame: Baseline pre-intervention, immediately post-intervention, and 1 year after intervention
measure: Changes in Eating Pathology: Ontario Bariatric Eating Self-Efficacy Scale (OBESE) - Changes in Eating Pathology
timeFrame: Baseline pre-intervention, immediately post-intervention, and 1 year after intervention
Secondary outcomes:
measure: Satisfaction with Therapy: Working Alliance Inventory - Short Form (WAI-SF)
timeFrame: Weekly up to 6 weeks during intervention and immediately post-intervention
measure: Changes in Depression Severity
timeFrame: Baseline pre-intervention, weekly up to 6 weeks during intervention, immediately post-intervention, and 1 year after intervention
measure: Changes in Anxiety Severity
timeFrame: Baseline pre-intervention, immediately post-intervention, and 1 year after intervention
measure: Changes in Health-Related Quality of Life
timeFrame: Baseline pre-intervention, immediately post-intervention, and 1 year after intervention
measure: Satisfaction with Therapy: Tele-CBT Client Change Interview
timeFrame: Weekly up to 6 weeks during intervention, immediately post-intervention, 1 year after intervention
measure: Satisfaction with Therapy: Helpful Aspects of Therapy Form (HAT)
timeFrame: Weekly up to 6 weeks during intervention and immediately post-intervention
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Toronto Western Hospital with the University Health Network
state: Ontario
Study officials:
affiliation: University of Toronto, Toronto Western Hospital
name: Sanjeev Sockalingam, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
affiliation: Toronto Metropolitan University
name: Stephanie E Cassin, PhD, CPsych
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Toronto, Toronto Western Hospital
name: Raed Hawa, MD, FRCPC
role: STUDY_DIRECTOR
affiliation: University of Toronto, Toronto Western Hospital
name: Susan Wnuk, PhD, CPsych
role: STUDY_DIRECTOR
affiliation: University of Toronto, Toronto Western Hospital
name: Timothy Jackson, MD, FRCSC
role: STUDY_DIRECTOR
affiliation: University Health Network, Toronto
name: Chau Du, MSc
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.