Search

Background: Patients with obesity often experience psychological distress, specifically depression symptoms. Due to various barriers, such as limitations of healthcare offers, digital interventions, for example medical apps, can provide a suitable approach to support affected people. In the envisaged prospective randomized controlled trial, we aim to examine the efficacy of the LightMood intervention. The LightMood intervention is a manualized and user-centered, digital intervention for patients with obesity, with a duration of 4 months, which contains elements of cognitive behavioral therapy and mindfulness-based and skills-based exercises. We expect the LightMood intervention to be superior to treatment as usual (TAU) in terms of reducing depression symptoms., Methods: The trial incorporates four distinct measurement time points: the baseline assessment, the post-treatment assessment, and 1- and 3-month follow-up assessments. Furthermore, we implemented in-treatment assessments for both groups. Participants will be randomized into two groups (LightMood intervention vs TAU). The aim is to include 128 participants (64 per group) in the study. Inclusion criteria are patients who are obese, at least 18 years old, with a private Internet access, and with adequate digital literacy and show depression symptoms (PHQ ≥ 10). Exclusion criteria are weekly outpatient individual psychotherapy, obesity surgery within the last year or planned within the next 7 months, no private Internet access, and the prescription of a new psychotropic drug within the last 2 weeks. The primary outcome is the post-assessment reduction in depression symptoms. Secondary outcomes will include the improvement in self-efficacy, quality of life, mindfulness, reduction in eating disorder symptoms, and body mass index (BMI). Furthermore, we expect a positive development of depression symptoms throughout the different time points (T1, T2, and T3) in patients with obesity., Discussion: LightMood is an evidence-based, efficient, low-threshold online intervention that aims to reduce depression symptoms in people with obesity. Online interventions could offer a promising alternative to conventional face-to-face therapy. The primary objective of the current study is to add essential insight into the feasibility, efficacy, effectiveness, and acceptance of e-mental health interventions for people with obesity and depression symptoms., Trial Registration: German Clinical Trial Register (DRKS), DRKS00029219. Registered on May 19, 2023., (© 2024. The Author(s).)

Introduction: The SARS-CoV-2 (COVID-19) pandemic poses immense challenges for national and international healthcare systems. Especially in times of social isolation and governmental restrictions, mental health should not be neglected. Innovative approaches are required to support psychologically burdened people. The e-mental health intervention 'CoPE It' has been developed to offer manualised and evidence-based psychotherapeutic support adapted to COVID-19-related issues in order to overcome psychological distress. In our study, we aim to assess the efficacy of the e-mental health intervention 'CoPE It' in terms of reducing distress (primary outcome), depression and anxiety symptoms as well as improving self-efficacy, quality of life and mindfulness (secondary outcomes). Furthermore, we want to evaluate the programme's usability, feasibility and participants' satisfaction with 'CoPE It' (tertiary outcome)., Methods and Analysis: The e-mental health intervention 'CoPE It' consists of four 30 min modules, conducted every other day, involving psychotherapeutic techniques of mindfulness-based stress reduction and cognitive-behavioural therapy. The widely applied and previously established content has been adapted to the context of the COVID-19 pandemic by experts in psychosomatic medicine and stress prevention. In our longitudinal study, adult participants-with adequate German language and computer skills, and who have provided informed consent-will be recruited via emergency support hotlines in Germany. Flyers will be distributed, and online channels will be used. Participants will complete a baseline assessment (T0), a postintervention assessment (T1) and assessments 1 and 3 months later (T2 and T3, respectively). We will perform repeated measures analysis of covariance, mixed linear models, standard analyses of variance and regression, and correlation coefficients. In case of binary outcome variables, either mixed logistic regression or χ² tests will be used., Ethics and Dissemination: The Ethics Committees of the University of Duisburg-Essen (20-9243-BO) and University of Tübingen (469/2020BO) approved the study. Results will be published in peer-reviewed journals and conference presentations., Trial Registration Number: DRKS00021301., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: Cancer-affected patients experience high distress due to various burdens. One way to expand psycho-oncological support is through digital interventions. This protocol describes the development and structure of a web-based psycho-oncological intervention, the Make It Training optimized. This intervention is currently evaluated in the Reduct trial, a multicenter randomized controlled trial. Methods: The Make It Training optimized was developed in six steps: A patient need and demand assessment, development and acceptability analysis of a prototype, the formation of a patient advisory council, the revision of the training, implementation into a web app, and the development of a motivation and evaluation plan. Results: Through a process of establishing cancer-affected patients' needs, prototype testing, and patient involvement, the Make It Training optimized was developed by a multidisciplinary team and implemented in a web app. It consists of 16 interactive self-guided modules which can be completed within 16 weeks. Discussion: Intervention protocols can increase transparency and increase the likelihood of developing effective web-based interventions. This protocol describes the process and results of developing a patient-oriented intervention. Future research should focus on the further personalization of web-based psycho-oncological interventions and the potential benefits of combining multiple psychotherapeutic approaches. [ABSTRACT FROM AUTHOR]