RESUMEN
INTRODUCTION: Insomnia is highly prevalent in outpatients receiving treatment for mental disorders. Cognitive-behavioural therapy for insomnia (CBT-I) is a recommended first-line intervention. However, access is limited and most patients with insomnia who are receiving mental healthcare services are treated using medication. This multicentre randomised controlled trial (RCT) examines additional benefits of a digital adaptation of CBT-I (dCBT-I), compared with an online control intervention of patient education about insomnia (PE), in individuals referred to secondary mental health clinics. METHODS AND ANALYSIS: A parallel group, superiority RCT with a target sample of 800 participants recruited from treatment waiting lists at Norwegian psychiatric services. Individuals awaiting treatment will receive an invitation to the RCT, with potential participants undertaking online screening and consent procedures. Eligible outpatients will be randomised to dCBT-I or PE in a 1:1 ratio. Assessments will be performed at baseline, 9 weeks after completion of baseline assessments (post-intervention assessment), 33 weeks after baseline (6 months after the post-intervention assessment) and 61 weeks after baseline (12 months after the post-intervention assessment). The primary outcome is between-group difference in insomnia severity 9 weeks after baseline. Secondary outcomes include between-group differences in levels of psychopathology, and measures of health and functioning 9 weeks after baseline. Additionally, we will test between-group differences at 6-month and 12-month follow-up, and examine any negative effects of the intervention, any changes in mental health resource use, and/or in functioning and prescription of medications across the duration of the study. Other exploratory analyses are planned. ETHICS AND DISSEMINATION: The study protocol has been approved by the Regional Committee for Medical and Health Research Ethics in Norway (Ref: 125068). Findings from the RCT will be disseminated via peer-reviewed publications, conference presentations, and advocacy and stakeholder groups. Exploratory analyses, including potential mediators and moderators, will be reported separately from main outcomes. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov Registry (NCT04621643); Pre-results.
Asunto(s)
Terapia Cognitivo-Conductual , Servicios de Salud Mental , Trastornos del Inicio y del Mantenimiento del Sueño , Humanos , Estudios Multicéntricos como Asunto , Noruega , Educación del Paciente como Asunto , Ensayos Clínicos Controlados Aleatorios como Asunto , Trastornos del Inicio y del Mantenimiento del Sueño/terapia , Resultado del TratamientoRESUMEN
The scope and variety of video games and monetary gambling opportunities are expanding rapidly. In many ways, these forms of entertainment are converging on digital and online video games and gambling sites. However, little is known about the relationship between video gaming and gambling. The present study explored the possibility of a directional relationship between measures of problem gaming and problem gambling, while also controlling for the influence of sex and age. In contrast to most previous investigations which are based on cross-sectional designs and non-representative samples, the present study utilized a longitudinal design conducted over 2 years (2013, 2015) and comprising 4601 participants (males 47.2%, age range 16-74) drawn from a random sample from the general population. Video gaming and gambling were assessed using the Gaming Addiction Scale for Adolescents and the Canadian Problem Gambling Index, respectively. Using an autoregressive cross-lagged structural equation model, we found a positive relationship between scores on problematic gaming and later scores on problematic gambling, whereas we found no evidence of the reverse relationship. Hence, video gaming problems appear to be a gateway behavior to problematic gambling behavior. In future research, one should continue to monitor the possible reciprocal behavioral influences between gambling and video gaming.