SHIFTPLAN: an RCT Investigating the Effect of a Shift Work Intervention on Fatigue, Sleep and Health.

Summary

Shift work is associated with disturbed life rhythms resulting from chronic exposure to circadian misalignment and sleep restriction, with long-term participation in most shift schedules causing serious health problems. Epidemiological data show that shift workers are at increased risk of sleepiness, fatigue and insomnia, cardiovascular disease, breast cancer and shift-work disorder. Prevalence estimates of shift-work disorder vary between 5% and 26,5%.

Given these widespread and serious health and functional consequences of shift work, there is a necessity for treatments that improve shift workers' health and work performance. Most non-pharmacological recommendations mention improved scheduling, bright-light exposure, napping, psychoeducation fostering sleep hygiene, and cognitive-behavioral interventions.

The effects of shift work on the health, fatigue and sleepiness of drivers have been robustly investigated in observational studies, as well as the effects of single measures such as scheduling or resting times. But studies on the effectiveness of countermeasures against the adverse impact of shift work are sparse, especially for high-risk populations such as professional drivers and controlled intervention studies are lacking. Several other investigators expounded the need for a multi-level approach to managing occupational sleep-related fatigue and workplace interventions to promote sleep and health of shift workers. Highlighting the high public-health burden associated with lack of recuperative sleep, the authors pointed out the pressing need to develop policies and implement programs aimed at improving workers' sleep health.

With SHIFTPLAN, the investigators aim to fill this gap in comprehensive approaches. To their knowledge, this is the first randomised controlled trial to systematically gauge the effect of a multimodal program that includes ergonomic shift scheduling and an educational program on well-defined health, sleep and performance outcomes in professional drivers.

Conditions

• Shift-work Disorder
• Insomnia
• Fatigue
• Mental Health Issue
• Quality of Life
• Coping Skills
• Circadian Rhythm Disorders

Interventions

BEHAVIORAL

Education program and ergonomic schedulling

The duration: six months. The explicit choice for a multimodal intervention to be tested as a whole is in line with the assertion of other experts that workplace interventions using a single approach will not be effective. Multimodal intervention 1. Implementing healthy scheduling. This will imply fast forward-rotating shift schedules, being adapted to chronotype, allowing for adequate resting times between shifts and series of shifts, allowing for napping at work, in particular during the first two days of an early shift. 2. Education program for drivers: psychoeducation on the sleep-wake cycle chronotypes, based on the cognitive-behavioral treatment of insomnia (CBT-i), information on the impact of light on wakefulness and sleep, information on napping and creating awareness on daytime sleepiness, tools for stress reduction, physical exercise, information on healthy eating in the context of shiftwork The education program will consist of a one-day, 8-hour session.

Sponsors & Collaborators

• Universiteit Antwerpen

  collaborator OTHER

• University Hospital, Antwerp

  lead OTHER

Principal Investigators

• Filip Van Den Eede, MD, PhD · Antwerp University Hospital (UZA). University of Antwerp (UA)

• Johan Verbraecken, MD, PhD · Antwerp University Hospital (UZA). University of Antwerp (UA)

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Model

PARALLEL

Eligibility

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-10-31

Primary Completion

2023-05-31

Completion

2023-08-31