Evaluating a rehabilitative intervention for substance-dependent patients with and without their accompanying children in Germany (KontextSucht): study protocol for a non-randomised trial.

INTRODUCTION: People suffering from substance use disorders often live in social contexts with children or are parents themselves. Addicted parents show specific substance-related problems while raising their children, which often leads to various lifelong consequences for the children. The German rehabilitative treatment system allows bringing children to inpatient treatment centres. This mixed-methods study evaluates a newly developed intervention, called 'KontextSucht' or 'AddictionContext', for parents in rehabilitation treatment centres concerning the effectiveness of the intervention in parenting and abstinence outcome. METHODS AND ANALYSIS: The study uses a two-stage parallel mixed-methods design. A feasibility study (stage 1) and a benefit assessment (stage 2) will be conducted to evaluate the intervention. Both parts of the study will be carried out with qualitative and quantitative work packages. German-speaking parents of children 0-14 years will be included in this study. Qualitative data will be analysed using qualitative content analyses, whereas quantitative data will be analysed descriptively using regression analysis as well as linear mixed models. ETHICS AND DISSEMINATION: All participants will receive detailed information on the study and sign informed consent before data collection. The research team has obtained the approval of the Ethical Review Committee at the Technical University of Munich in Germany and will follow all legislation rules regarding data protection. The study results will be published in peer-reviewed national and international journals. Furthermore, the study results will be included in an intervention manual distributed to treatment centres. TRIAL REGISTRATION NUMBER: DRKS00030950.

Development, piloting and evaluation of an app-supported psychosocial prevention intervention to strengthen participation in working life: a study protocol of a mixed-methods approach.

INTRODUCTION: Rates of incapacity to work due to mental disorders have increased in many European countries. The consequences of persistent stress can impact individuals' physical and psychological well-being and gradually develop into chronic stress. Mental disorders or symptoms of burn-out syndrome can have severe consequences. Mental disorders leading to work incapacity significantly burden the health system. Prevention interventions can protect against burn-out, depression, anxiety and other mental health disorders. Digital health is a promising approach to increase the utilisation of effective prevention interventions. This mixed-methods study evaluates a newly developed app-supported psychosocial prevention intervention called 'RV Fit Mental Health' to strengthen participation in working life. METHODS AND ANALYSIS: The study uses a three-stage parallel mixed-methods design. This study accompanies the development (stage 1), piloting (stage 2) and evaluation (stage 3) of the new intervention. Within the stages, there is a quantitative as well as a qualitative research strand. Employed persons with an incipient mental disorder will be included. Additionally, experts within the project or connected areas will be included. Quantitative data will be analysed using multifactorial variance analyses in a pre-post design. Qualitative data will be analysed using qualitative content analysis. The study is a comprehensive research approach to investigate the development, piloting and evaluation of an app-supported psychosocial app-based prevention intervention. The rigour of the study will be achieved through data triangulation. ETHICS AND DISSEMINATION: All participants will receive detailed study information and give written informed consent before data collection. Ethical approval was obtained from the Technical University of Munich Ethics Committee. All data collection will follow all legislative rules regarding data protection, also following the Declaration of Helsinki. The study results will be disseminated in peer-reviewed journals and presented at international conferences. TRIAL REGISTRATION NUMBERS: DRKS00030818 and DRKS00033080.