RESUMEN
BACKGROUND: Many shift workers suffer from sleep issues, which negatively affect quality of life and performance. Scientifically evaluated, structured programs for prevention and treatment are scarce. We developed an anonymous online cognitive behavioral therapy for insomnia (CBT-I) program. After successful completion of a feasibility study, we now start this prospective, randomized, controlled superiority trial to compare outcomes of two parallel groups, namely an intervention group and a waiting-list control-group. Additionally, we will compare these outcomes to those of a face-to-face CBT-I outpatient sample. METHODS: Collaborating companies will offer our anonymous online intervention to their shift-working employees. Company physicians and counseling services will screen those interested for inclusion and exclusion criteria. Participants will receive access to our online service, where they will complete psychometric assessment and receive random assignment to either the intervention group or the waiting-list control group. Participants and providers will be aware of the group assignment. We aim to allocate at least N = 60 participants to the trial. The intervention consists of psychoeducation, sleep restriction, stimulus control, relaxation techniques, and individual feedback delivered via four e-mail contacts. During the intervention, as well as during the waiting period, participants will fill out weekly sleep diaries. Immediately after completion of the program, the post-intervention assessment takes place. Participants in the control group will be able to participate in the program after all study assessments. To recruit an additional sample, collaborating outpatient sleep clinics will provide six sessions of standard face-to-face CBT-I to an ad hoc sample of shift working patients. We expect both the online and the face-to-face CBT-I interventions to have beneficial effects compared to the control group on the following primary outcomes: self-reported symptoms of depression and insomnia, sleep quality, and daytime sleepiness. CONCLUSIONS: The online intervention allows shift workers to follow a CBT-I program independently of their working schedule and location. Forthcoming results might contribute to further improvement of prevention and therapy of sleep issues in shift workers. TRIAL REGISTRATION: German Clinical Trials Register DRKS DRKS00017777 . Registered on 14 January 2020-retrospectively registered.
Asunto(s)
Terapia Cognitivo-Conductual , Trastornos del Inicio y del Mantenimiento del Sueño , Trastornos del Sueño-Vigilia , Humanos , Estudios Prospectivos , Calidad de Vida , Ensayos Clínicos Controlados Aleatorios como Asunto , Trastornos del Inicio y del Mantenimiento del Sueño/diagnóstico , Trastornos del Inicio y del Mantenimiento del Sueño/terapia , Resultado del TratamientoRESUMEN
In western societies, about one in six employees works in shifts. Shiftwork is associated with a number of poor somatic and psychological health outcomes, especially sleep issues. Higher rates of absenteeism and accidents in the workplace are possible consequences. Still, prevention programs and treatment options that are specifically tailored to shift-workers' needs are rare. We devised a 4-week online cognitive behavioral therapy for insomnia (CBT-I) intervention (n = 21) and compared sleep outcomes to a face-to-face outpatient treatment for shift-workers (n = 12) using a sleep diary and the Epworth Sleepiness Scale (ESS). In the online sample, measures also included the World Health Organization wellbeing questionnaire (WHO-5) and the Insomnia Severity Index (ISI). In the outpatient sample, the Beck Depression Inventory (BDI-II), the Montgomery-Åsberg Depression Rating Scale (MADRS), and the Pittsburgh Sleep Quality Index (PSQI) were administered. Results showed significant improvements in sleep efficiency by 7.2% in the online sample and 7.7% in the outpatient sample. However, no significant difference was found in the rate of improvement in sleep efficiency across four weeks of treatment between the samples. In the online sample, the wellbeing (WHO-5) and insomnia symptoms (ISI) scores were significantly improved following the CBT-I intervention (p < 0.004 and p < 0.002 respectively). In the outpatient sample, symptoms of depression (BDI-II and MADRS scores) and insomnia symptoms (PSQI scores) improved significantly following the CBT-I intervention. In summary, CBT-I significantly improved sleep efficiency in both the online and outpatient samples, in addition to wellbeing, symptoms of insomnia, and depression. The findings of this study demonstrate online CBT-I as a feasible approach for treating insomnia in shift-workers. Future randomized controlled trials are needed.