Anonymous online cognitive behavioral therapy for sleep disorders in shift workers—a study protocol for a randomized controlled trial

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.