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

Obesity Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Obesity

• NCT number: NCT02920112
• Study type: Interventional
• Source: University Health Network, Toronto
• Status: Completed
• Phase: N/A
• Start date: May 2014
• Completion date: March 2018