Testing an early online intervention for the treatment of disturbed sleep during the COVID-19 pandemic (Sleep COVID-19): structured summary of a study protocol for a randomised controlled trial.
Level 5 - mechanism / opinion, no new human data
Study protocol reporting no empirical data or clinical results
PubMed 32771068 · doi:10.1186/s13063-020-04644-0
What was done
This is a study protocol for an online cluster randomized controlled trial (conducted via Northumbria University) evaluating an early digital self-help intervention for acute insomnia during the COVID-19 pandemic. A target minimum of 60 participants will be enrolled: 30 poor sleepers (meeting DSM-5 criteria for acute insomnia lasting 2 weeks to 3 months) randomized 1:1 to an intervention or a 1-month wait-list control group, and 30 good sleepers randomized 1:1 to an intervention or no-intervention group. The intervention consists of a downloadable self-help PDF leaflet providing sleep education, stimulus control guidance, and cognitive distraction techniques. Primary outcome is insomnia severity measured by the Insomnia Severity Index (ISI) at 1 week, 1 month, and 3 months post-intervention. Secondary outcomes include anxiety (GAD-7), depression (PHQ-9), and sleep diary continuity measures.
What was found
The abstract reports no empirical findings or numerical results. Recruitment had not started at the time of publication.
Why it matters
Acute sleep disruption was common during the COVID-19 pandemic; establishing a protocol for a low-cost, scalable online self-help leaflet could provide a practical early intervention to prevent acute insomnia from transitioning into chronic sleep disorders.
Limits
No data or results are reported because this is strictly a trial protocol. The planned sample size is very small (minimum n = 60 total, with roughly 15 participants per arm). Participants cannot be blinded to allocation, and all screening criteria and outcome measures rely entirely on subjective self-report questionnaires and sleep diaries.
Cited by
- supports Chronic insomnia disorder is clinically defined as persistent difficulty initiating or maintaining sleep or waking up too early occurring at least three nights per week for at least three months, with daytime impairment.