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

Study Overview
=================
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.

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

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Behavioral: Telephone based Cognitive Behavioral Therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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. Exclusion Criteria: Active suicidal ideation. Active serious mental illness Active severe depression Active severe anxiety Active symptoms of post-traumatic stress disorder

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Obesity, Bariatric Surgery, Bariatrics, Cognitive Therapy, Binge eating