Web-based mindfulness and skills-based distress reduction for patients with cancer: study protocol of the multicentre, randomised, controlled confirmatory intervention trial Reduct.

INTRODUCTION: Many patients with cancer experience severe psychological distress, but as a result of various barriers, few of them receive psycho-oncological support. E-mental health interventions try to overcome some of these barriers and the limitation of healthcare offers, enabling patients with cancer to better cope with psychological distress. In the proposed trial, we aim to assess the efficacy and cost-effectiveness of the manualised e-mental health intervention Make It Training- Mindfulness-Based and Skills-Based Distress Reduction in Oncology. Make It Training is a self-guided and web-based psycho-oncological intervention, which includes elements of cognitive behavioural therapy, mindfulness-based stress reduction and acceptance and commitment therapy. The training supports the patients over a period of 4 months. We expect the Make It Training to be superior to treatment as usual optimised (TAU-O) in terms of reducing distress after completing the intervention (T1, primary endpoint). METHODS AND ANALYSIS: The study comprises a multicentre, prospective, randomised controlled confirmatory interventional trial with two parallel arms. The proposed trial incorporates four distinct measurement time points: the baseline assessment before randomisation, a post-treatment assessment and 3 and 6 month follow-up assessments. We will include patients who have received a cancer diagnosis in the past 12 months, are in a curative treatment setting, are 18-65 years old, have given informed consent and experience high perceived psychological distress (Hospital Anxiety and Depression Scale ≥13) for at least 1 week. Patients will be randomised into two groups (Make It vs TAU-O). The aim is to allocate 600 patients with cancer and include 556 into the intention to treat analysis. The primary endpoint, distress, will be analysed using a baseline-adjusted ANCOVA for distress measurement once the intervention (T1) has been completed, with study arm as a binary factor, baseline as continuous measurement and study centre as an additional categorical covariate. ETHICS AND DISSEMINATION: The Ethics Committee of the Medical Faculty Essen has approved the study (21-10076-BO). Results will be published in peer-reviewed journals, conference presentations, the project website, and among self-help organisations. TRIAL REGISTRATION NUMBER: German Clinical Trial Register (DRKS); DRKS-ID: DRKS00025213.

Metabolic Surgery Supporting Aftercare via Group-Intervention (MeSSAGES): study protocol of a randomised controlled trial.

INTRODUCTION: Obesity is a constantly rising and cost-intensive medical issue worldwide. Severe obesity often needs surgery to promote weight loss, but due to the rapid therapeutic success after the surgery, many patients lack the awareness of the need to consistently maintain the postoperative care. However, therapeutic success and psychological well-being can be increased through group interventions and social support of the group members. Therefore, aftercare via group intervention is a promising approach. In this prospective randomised controlled study, the self-efficacy in a social media-based interactive, psychoeducational intervention is to be tested. METHODS AND ANALYSIS: The intervention group will complete a social media-supported group intervention for 6 weeks with weekly postings of educative contents and the possibility to exchange in groups via anonymous avatars. The control group will receive treatment as usual (TAU) after the obesity surgery as recommended in the German S3-guidelines Obesity Surgery and Metabolic Surgery. We will examine the effectiveness of a social media-supported intervention group, and therefore, the change in self-efficacy expectation. For the primary outcome, we will perform a mixed analysis of variance with time as the within-subject factor (times of measurement T0-T4) and the group assignment as the between-subject factor (intervention +TAU vs TAU group). ETHICS AND DISSEMINATION: The study was approved by the Medical Association North Rhine (Ärztekammer Nordrhein, 2020031) and the patient enrolment will begin in July 2021. TRIAL REGISTRATION NUMBER: DRKS00018089.

Generalized Anxiety as a Risk Factor for Dysfunctional Eating Behavior after Obesity Surgery during the COVID-19 Pandemic.

Purpose: The present study investigates the impact of obesity surgery on mental health (i.e., eating behavior and distress) during the COVID-19 pandemic. Methods: Two hundred fifty-four participants were recruited via social media. One hundred fourteen (44.53%) of them were surgery candidates (waiting for obesity surgery), while 142 (55.46%) had already undergone surgery. Participants who underwent surgery were compared to participants that did not yet undergo surgery in terms of mental burden (depression and anxiety), as well as safety and eating behavior. Further moderation analyses attempted to identify risk factors for increased COVID-19-related dysfunctional eating behavior after surgery. Results: Participants who underwent surgery showed generally lower levels of depression and general anxiety on a trend level. Moderation analyses suggested that people with high levels of generalized anxiety actually show more dysfunctional COVID-19-specific eating behavior after obesity surgery. Conclusion: On a trend level, obesity surgery appears to attenuate symptoms of generalized anxiety and depression. Yet, surgery patients with high levels of generalized anxiety exhibit even higher levels of dysfunctional eating during the COVID-19 pandemic. It is therefore particularly important to support people at risk.

COVID-19-Related Fear and Health-Related Safety Behavior in Oncological Patients.

OBJECTIVE: This study aimed to assess cancer patients' psychological burden during the COVID-19 pandemic by investigating distress (distress-thermometer), health status (EQ-5D-3L), general anxiety (GAD-7), COVID-19-related fear and associated behavioral changes and comparing these to matched healthy controls, using propensity score matching (PSM). METHODS: During the first days of the COVID-19 pandemic in Germany, March 16 to 30, 2020, 150 actually treated cancer patients and 150 matched healthy controls participated in this study. Participants completed an anonymous online survey assessing health status, distress, general anxiety, COVID-19-related fear and behavioral changes (i.e., adherent safety behavior and dysfunctional safety behavior). RESULTS: Cancer patients showed no elevated level of distress, U = 10,657.5, p = 0.428, general anxiety U = 10,015.5, p = 0.099, or COVID-19-related fear compared to healthy controls, U = 10,948, p = 0.680. Both groups showed elevated COVID-19-related fear. Cancer patients reported more adherent safety behavior, such as washing hands more often or avoiding public places, U = 8,285, p < 0.001, d = 0.468. They also reported more dysfunctional safety behavior such as buying larger quantities of basic food, compared to healthy controls U = 9,599, p = 0.029, d = 0.256. Adherent safety behavior could be significantly explained by cancer diagnosis, increased COVID-19-related fear and subjective level of information about COVID-19, R 2 = 0.215, F(3) = 27.026, p < 0.001. CONCLUSION: This suggests that cancer patients are more likely to utilize adherent safety behavior. Cancer patients reported comparable levels of distress and anxiety compared to healthy controls. Still, the COVID-19 pandemic is associated with elevated COVID-19-related fear. Therefore, specific interventions are needed to prevent anxiety and improve mental health during the COVID-19 pandemic.