A telephone- and text-message based telemedical care concept for patients with mental health disorders - study protocol for a randomized, controlled study design

BACKGROUND: As in other countries worldwide, the prevalence of mental disorders in Germany is high. Although numerically a dense network of in- and outpatient psychiatric health services exists, the availability in rural and remote regions is insufficient. In rural regions, telemedical concepts can be a chance to unburden and complement the existing healthcare system. Telemedical concepts consisting of video or telephone consulting show first positive results, but there are only a few studies with a randomized controlled design. To improve the treatment of patients with mental disorders in rural regions, we developed a telemedical care concept based on telephone contacts and text-messages. The primary objective of this study is to evaluate the effects of the telemedical interventions on psychopathological outcomes, e. g. anxiety, depressive symptoms, and somatisation. Secondary objective of the study is the analysis of intervention effects on the frequency of medical contacts with healthcare services. Furthermore, the frequency of patients' crises and the frequency and kind of interventions, initiated by the project nurses will be evaluated. We will also evaluate the acceptance of the telemedical care concept by the patients. METHODS/DESIGN: In this paper we describe a three-armed, randomized, controlled study. All participants are recruited from psychiatric day hospitals. The inclusion criteria are a specialist-diagnosed depression, anxiety disorder, adjustment disorder or a somatoform disorder and eligibility to participate in the study. Exclusion criteria are ongoing outpatient psychotherapy, planned interval treatment at the day clinic and expected recurrent suicidality and self-injuring behaviour. The interventions consist of regular patient-individual telephone consultations or telephone consultations with complementing text-messages on the patients' mobile phone. The interventions will be conducted during a time period of 6 months. TRIAL REGISTRATION: This study is registered in the German Clinical Trials Register (DRKS00000662).