Does unguided app-based self-management improve mental health literacy, patient empowerment, and access to care for people with mental disorders? Study protocol for a randomized controlled trial
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BMJ Open. 2021 Jul 15; 11 (7): e049688. doi: 10.1136 / bmjopen-2021-049688.
INTRODUCTION: Mental disorders represent a huge burden both on individuals and on health systems. Symptoms and syndromes often go undetected and untreated, resulting in comorbidity and chronification. In addition to the limited resources of health systems, the treatment gap is, to a large extent, caused by internal barriers within the person that prevent early treatment seeking. These barriers include a lack of confidence in professionals, fear of stigma, or the desire to deal with problems without professional help. Although unguided self-management interventions are not designed to replace psychotherapy, they can promote early symptom assessment and recognition by reducing internal barriers. Digital self-management solutions can also reduce inequalities in access to care due to external factors such as regional unavailability of services.
METHODS AND ANALYSIS: Approximately 1,100 patients with mild to moderate mental disorders of depression, anxiety, sleep, diet or somatization will be randomized to receive either a low threshold digital unguided self-management tool below. the form of a transdiagnostic mental health app. or take care as usual. The primary outcomes will be mental health literacy, patient empowerment and access to care, while the secondary outcomes will be symptom distress and quality of life. Additional moderating and predictor variables are negative life events, personality functioning, client satisfaction, use of mental health services, and application of self-management strategies. Data will be collected at baseline as well as 8 weeks and 6 months after randomization. Data will be analyzed using multiple imputation and analysis of covariance using the intent-to-treat principle, while sensitivity analyzes will be based on different multiple imputation parameters and protocol analysis. .
ETHICS AND DISSEMINATION: Approval was obtained from the Ethics Committee of the Faculty of Educational Sciences and Psychology of Freie Universität Berlin. The results will be submitted to specialized peer-reviewed journals and presented at national and international conferences.
TEST REGISTRATION: The test has been recorded in the DRKS Trial Register (DRKS00022531); Pre-results.