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Clinical Trials/ISRCTN43900695
ISRCTN43900695
Completed
N/A

Testing an early online intervention for the treatment of disturbed sleep during the COVID-19 pandemic (Sleep COVID-19)

orthumbria University0 sites344 target enrollmentApril 8, 2020
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ConditionsAcute insomniaMental and Behavioural Disorders

Overview

Phase
N/A
Intervention
Not specified
Conditions
Acute insomnia
Sponsor
orthumbria University
Enrollment
344
Status
Completed
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

2020 Protocol article in https://pubmed.ncbi.nlm.nih.gov/32771068/ protocol (added 13/08/2020) 2021 Protocol article in https://pubmed.ncbi.nlm.nih.gov/34895327/ (added 14/12/2021) 2024 Results article in https://pubmed.ncbi.nlm.nih.gov/38430544/ (added 13/05/2024)

Registry
who.int
Start Date
April 8, 2020
End Date
April 6, 2022
Last Updated
last year
Study Type
Interventional
Sex
All

Investigators

Sponsor
orthumbria University

Eligibility Criteria

Inclusion Criteria

  • •All participants must:
  • •1\. Be aged 18 years and above
  • •2\. Have a sufficient level of English comprehension to understand and complete questionnaires
  • •Poor sleepers:
  • •1\. Must have difficulties in falling asleep, staying asleep, or awakening too early at least three nights per week, for a time period of between two weeks and three months
  • •2\. Must have distress or impairment caused by sleep loss
  • •3\. Both 1\. and 2\. must occur despite the individual having an adequate opportunity for sleep
  • •Good sleepers:
  • •1\. No current sleep problems

Exclusion Criteria

  • •Current exclusion criteria as of 28/07/2020:
  • •1\. Individuals who report having chronic sleep problems (i.e. where they have existed for more than 3 months immediately prior to providing consent)
  • •2\. Those who are actively seeking treatment for their sleep problems, irrespective of how long they have had the sleep problem
  • •3\. Participants who have a self\-reported history of head injury, or who have had a diagnosis of schizophrenia, epilepsy or personality disorder cannot take part as the distraction techniques involved in the intervention may increase rumination and this may influence the effectiveness of the intervention
  • •Previous exclusion criteria:
  • •Poor sleepers:
  • •1\. Long\-term (i.e. chronic) sleep problems (\> 3 months)

Outcomes

Primary Outcomes

Not specified

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