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

Abstract

Background Patients undergoing bariatric surgery have high rates of psychiatric comorbidity, which may increase their vulnerability to COVID-19-related mental health distress. Exacerbation of mental health distress and disordered eating could have significant negative effects on long-term weight management and quality of life for these patients if untreated. Objective To determine the efficacy of a telephone-based cognitive behavioral therapy (Tele-CBT) intervention in improving depressive, anxiety, and disordered eating symptoms during COVID-19. Methods Participants were recruited as part of a larger randomized controlled trial study (clinicaltrials.gov ID: NCT03315247) between March 2020 and March 2021 and randomized 1:1 to receive Tele-CBT or standard bariatric care. Outcomes of Generalized Anxiety Disorder-7 (GAD-7), Patient Health Questionnaire-9 (PHQ-9), Emotional Eating Scale (EES), and Binge Eating Scale (BES) were measured at baseline, immediately post-intervention, and 3 months post-intervention. Linear mixed models were used to test the effect of intervention group, time, and group-by-time interaction for each outcome. Results Eighty-one patients were included in the intention-to-treat analysis. Mean (SD) age of participants was 47.68 (9.36) years and 80.2% were female. There were significant group-by-time interactions for all outcomes and significant differences between groups across time. There were significant decreases in mean GAD-7 ( p = 0.001), PHQ-9 ( p < 0.001), EES-Total ( p = 0.001), EES-Anger ( p = 0.003), EES-Anxiety ( p < 0.001), EES-Depression ( p < 0.001), and BES ( p = 0.002) scores for the Tele-CBT group at post-intervention and follow-up when compared to baseline and the control group. Conclusion Tele-CBT is a feasible and effective treatment for improving psychological distress and disordered eating among post-operative bariatric surgery patients during the COVID-19 pandemic. Graphical abstract

Telephone-based cognitive behavioural therapy for patients with postoperative bariatric surgery to manage COVID-19 pandemic-related mental health issues and distress (TELE-BARICARE): a protocol for a randomised controlled trial

“…Additionally, due to the short time frame in which the study will need to be conducted, the follow-up period for this study is limited to 3-month postintervention. Although previous research has shown that this short follow-up duration is sufficient in demonstrating the efficacy of the Tele-CBT intervention, 22 future studies could include additional follow-up timepoints to determine how the outcome measures change over prolonged periods of time.…”

“…The proposed effect sizes, SD and correlation between measurement pairs were estimated from the preliminary results in our current RCT. 22 While the trial is powered to detect differences in the multiple primary endpoints, a sample size of N=118 participants will achieve ≥90% power to detect differences in each of the secondary endpoints. Assuming an expected accrual rate of 11-12 participants per month across 4 sites, participant accrual is expected to complete in 12 months.…”

“…Previous research has demonstrated that a telephone-based CBT (Tele-CBT) intervention, developed specifically for patients who have undergone bariatric surgery, can improve depressive, anxiety and disordered eating symptoms in this population 19–21. Furthermore, a recently published pilot study examining the effectiveness of this intervention in a subsample of patients with post-bariatric surgery during the COVID-19 pandemic showed that patients receiving Tele-CBT had significant improvements in depression, anxiety, binge eating and emotional eating symptoms immediately postintervention and at 3-month postintervention follow-up, whereas the control group did not 22. Given that these results were preliminary and the study was not specifically designed to assess efficacy for COVID-19 related distress (ie, participation was not limited to those experiencing significant distress, the control group did not receive COVID-19-specific resources, the study was not sufficiently powered and adaptations for historically excluded and underserved populations were not considered), the current study proposes to test whether Tele-CBT is an efficacious intervention among patients managing obesity after bariatric surgery who are experiencing psychological distress or disordered eating associated with the COVID-19 pandemic.…”

“…This sample size will achieve 96.2% power to detect a difference of mean changes of −3.4 between arms for PHQ-9, with SD=5.0 and ρ=0.597. The proposed effect sizes, SD and correlation between measurement pairs were estimated from the preliminary results in our current RCT 22. While the trial is powered to detect differences in the multiple primary endpoints, a sample size of N=118 participants will achieve ≥90% power to detect differences in each of the secondary endpoints.…”

24‐Monthfollow‐upof randomized controlled trial of guided‐self‐helpfor loss‐of‐controleating after bariatric surgery

“…We offer a brief comparison of our findings to the literature to provide broader context, but we emphasize that this should be viewed cautiously given the paucity of treatment studies with patients following bariatric surgery (David et al, 2020;Sarwer & Heinberg, 2020;Stewart & Avenell, 2016), the dearth of interventions for LOC-eating, and the substantial differences across "broader relevant" studies in their methodologies, comparison groups, therapists, patient groups, and clinical settings. Initial reports for a low-intensity "CBT-type" telephone intervention also delivered 6 months postbariatric surgery indicated statistically significant short-term reductions among a mixed sample for binge-eating-related symptoms (not specifically LOC-eating), weight, and depression (Sockalingam et al, 2017(Sockalingam et al, , 2022. Reviews (David et al, 2020;Stewart & Avenell, 2016) of small trials (mainly brief low-intensity interventions without follow-ups) delivered postoperatively (without assessment of LOC-eating or binge eating) have reported some instances of statistically significant acute weight losses but the main findings tend to be modest and mixed.…”