Effectiveness of a Digital Cognitive Behavioral Therapy for Insomnia for Nurses with Shift Work Sleep Disorder: Results of a Randomized Controlled Trial

Abstract

Background Shift work is associated with many adverse effects on health and in particular affects sleep. One of the most common forms of insomnia in nurses is shift work sleep disorder. Face-to-face cognitive-behavioral therapy for insomnia can be challenging for shift-working nurses due to irregular work schedules. Digital therapy can offer a promising alternative to provide nurses with access to cognitive-behavioral therapy for insomnia. Objective This study investigated the effectiveness of the digital SleepCare intervention for reducing insomnia in nurses suffering from shift work sleep disorder. Design Randomized controlled trial Participants 74 nurses working suffering from shift work sleep disorder Methods In a two-arm randomized controlled trial, SleepCare was compared to shift work-specific psychoeducation published digitally by the German Sleep Society. The diagnosis of shift work sleep disorder was established through a clinical interview. The primary outcome was insomnia severity measured using the Insomnia Severity Index at baseline, 8 weeks and 3 months. Further indicators of mental health and long-term hair cortisol concentration were evaluated as secondary endpoints. Results Intention-to-treat analysis of covariance showed a greater reduction in insomnia severity in the intervention group versus psychoeducation, at both post-intervention (d=1.11[0.7-1.6]) and follow-up (d=0.97 [0.5-1.4]), corresponding to between-group differences of 5.0 and 5.3 points on the Insomnia Severity Index, respectively. Statistically significant effects were observed for sleep-related, but not other mental health indicators. The effects on insomnia were reflected in reduced long-term hair cortisol in the intervention group.   Conclusions SleepCare was effective at reducing insomnia symptoms to a clinically-meaningful extent and is one of the first programs that adapted to a digital cognitive-behavioral therapy for insomnia intervention to address nurses' needs with specific exercises for shift work. Biological evaluation using hair cortisol, collected from participants at home, was feasible and appropriate for preserving the advantages of digital interventions; namely, flexibility in time and place. Registration German Clinical Trials Register – DRKS; DRKS00027411 (https://trialsearch.who.int/Trial2.aspx?TrialID=DRKS00027411).Registration date: March 9, 2022. Start of recruitment: May 13, 2022.

Note:
Funding declaration: This work was part of the "Care4Care" research project on the health of healthcare workers and was funded by the German Association of Statutory Health Insurance (AOK). The funder was not involved in the study design, data analysis or data reporting

Conflict of Interests: None

No other competing interests declared

Ethics statement: The authors assert that all procedures contributing to this work comply with the ethical standards of the relevant national and institutional committees on human experimentation and with the Helsinki Declaration of 1975, as revised in 2008. The authors assert that all procedures contributing to this work comply with the ethical standards of the relevant national and institutional guides. The study involved human participants and was approved by the Ethics committee of Leuphana University. The ID is: EB-Antrag_202108-10-Lehr_Sleepcare. Participants gave informed consent to participate in the study before taking part.

Trial Registration: German Clinical Trials Register – DRKS; DRKS00027411 (https://trialsearch.who.int/Trial2.aspx?TrialID=DRKS00027411).

Keywords: sleep disorders, cognitive behavioral therapy, shift work, cortisol, sleep, Digital Health, internet-based intervention