Clinical trial NCT03315247: Tele-CBT Following Bariatric Surgery: Randomized Control Trial
Official title: Telephone-Based Cognitive Behavioural Therapy for Post-Operative Bariatric Surgery Patients: A Randomized Controlled Trial
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: 2017-10-20
Enrollment: 306
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Control Trial
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change in Weight
timeFrame: 1.25, 1.5, 2, 3 years post-surgery
Secondary outcomes:
measure: Changes in obesity-related medical comorbidities - Medication Burden
timeFrame: 2 and 3 years post-surgery
measure: Changes in obesity-related medical comorbidities - Medical Treatments
timeFrame: 2 and 3 years post-surgery
measure: Changes in obesity-related medical comorbidities - T2DM
timeFrame: 2 and 3 years post-surgery
measure: Changes in eating pathology - Emotional Eating
timeFrame: 1.25, 1.5, 2, and 3 years post-surgery
measure: Changes in eating pathology - Binge Eating
timeFrame: 1.25, 1.5, 2, and 3 years post-surgery
measure: Changes in eating pathology - Loss of Control
timeFrame: 1.25, 1.5, 2, and 3 years post-surgery
measure: Changes in eating pathology - Depression
timeFrame: 1.25, 1.5, 2, and 3 years post-surgery
measure: Changes in eating pathology - Quality of Life
timeFrame: 1.25, 1.5, 2, and 3 years post-surgery
measure: Changes in eating pathology - Anxiety
timeFrame: 1.25, 1.5, 2, and 3 years post-surgery
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Toronto Western Hospital
state: Ontario
Study officials:
affiliation: University of Toronto, University Health Network
name: Sanjeev Sockalingam, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
affiliation: Toronto Metropolitan University
name: Stephanie Cassin, PhD, CPsych
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Toronto, University Health Network
name: Raed Hawa, MD, FRCPC
role: STUDY_DIRECTOR
affiliation: University of Toronto, University Health Network
name: Susan Wnuk, PhD, CPsych
role: STUDY_DIRECTOR
affiliation: University of Toronto, University Health Network
name: Timothy Jackson, MD, FRCPC
role: STUDY_DIRECTOR
affiliation: Women's College Hospital
name: Lorraine Lipscombe, MD, FRCPC
role: STUDY_DIRECTOR
affiliation: University of Toronto, University Health Network
name: Allan Okrainec, MD, FRCPC
role: STUDY_DIRECTOR
affiliation: University of Toronto
name: George Tomlinson, PhD
role: STUDY_DIRECTOR
affiliation: University of Toronto, University Health Network
name: David Urbach, MD, FRCPC
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.