Abstract
BackgroundSleep disorders are a risk factor for developing a variety of mental disorders, have a negative impact on their remission rates and increase the risk of relapse. Early identification and treatment of sleep disorders is therefore of paramount importance. Unfortunately, in mental health care sleep disorders are often poorly recognized and specific treatment frequently occurs late or not at all. This protocol-paper presents a randomized controlled trial investigating the clinical relevance of early detection and treatment of sleep disorders in mental health care. The two aims of this project are 1) to determine the prevalence of sleep disorders in different mental disorders, and 2) to investigate the contribution of early identification and adequate treatment of sleep disorders in individuals with mental disorders to their sleep, mental disorder symptoms, general functioning, and quality of life.MethodsPatients newly referred to a Dutch mental health institute for psychiatric treatment will be screened for sleep disorders with the self-assessment Holland Sleep Disorders Questionnaire (HSDQ). Patients scoring above the cut-off criteria will be invited for additional diagnostic evaluation and, treatment of the respective sleep disorder. Participants will be randomly assigned to two groups: Immediate sleep diagnostics and intervention (TAU+SI-T0), or delayed start of sleep intervention (TAU+SI-T1; 6 months after inclusion). The effect of sleep treatment as add-on to treatment as usual (TAU) will be tested with regard to sleep disorder symptoms, general functioning, and quality of life (in collaboration with a psychiatric sleep centre).DiscussionThis trial will examine the prevalence of different sleep disorders in a broad range of mental disorders, providing information on the co-occurrence of specific sleep and mental disorders. Further, this study is the first to investigate the impact of early treatment of sleep disorders on the outcome of many mental disorders. Moreover, standard sleep interventions will be tailored to specific mental disorders, to increase their efficacy. The results of this trial may contribute considerably to the improvement of mental health care.Trial registrationThis clinical trial has been retrospectively registered in the Netherlands Trial Register (NL8389; https://www.trialregister.nl/trial/8389) on February 2th, 2020.
Highlights
Sleep disorders are a risk factor for developing a variety of mental disorders, have a negative impact on their remission rates and increase the risk of relapse
Aims and objectives The overall aim of this study is to investigate the clinical relevance of early identification and adequate treatment of sleep disorders that co-occur with mental disorders
If we would observe a high prevalence of a certain sleep disorder in connection to a particular mental disorder, extra attention can be paid and extra resources could be allocated to the detection and treatment of that specific sleep disorder within individuals who are diagnosed with this particular mental disorder
Summary
Design This study is designed as a randomized controlled trial in order to test the effects of early interventions for sleep disorders on both sleep problems and mental health outcome. Participants will be asked to complete several questionnaires concerning sleep, quality of life, general functioning and specific mental disorder symptomatology, at three different time points over the course of twelve months. The effects of added sleep intervention in all participants with a sleep disorder will be assessed at six and twelve months by comparison of treatment (TAU-SI-T0 and TAU-SI-T1) groups over time (T0, T1, and T2). A stepwise approach will be followed in which first results for crude models will be taken, after which models including potential confounders such as age, sex, and social demographic parameters are run These analyses will be performed in the total population for the quality of life and general symptom outcome parameters, and in the eight mental disorder diagnostic subpopulations (depressive disorder, bipolar disorder, anxiety disorder, PTSD, AD(H)D, ASD, SSD and personality disorder) for the specific mental disorder symptom parameters. Secondary analysis will only be performed within the more prevalent disorders: depression and PTSD
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