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Clinical Trials/ISRCTN42499563
ISRCTN42499563
Completed
N/A

A pragmatic, multicentre, randomised controlled trial comparing nurse-delivered sleep restriction therapy (SRT) for insomnia disorder to sleep hygiene (SH) in primary care

niversity of Oxford0 sites642 target enrollmentMay 31, 2018
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ConditionsInsomniaMental and Behavioural DisordersDisorders of initiating and maintaining sleep [insomnias]

Overview

Phase
N/A
Intervention
Not specified
Conditions
Insomnia
Sponsor
niversity of Oxford
Enrollment
642
Status
Completed
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

2020 Protocol article in https://pubmed.ncbi.nlm.nih.gov/32139496/ protocol (added 15/02/2021) 2023 Results article in https://pubmed.ncbi.nlm.nih.gov/37573859/ (added 14/08/2023) 2024 Results article in https://pubmed.ncbi.nlm.nih.gov/39185919/ (added 27/08/2024)

Registry
who.int
Start Date
May 31, 2018
End Date
April 6, 2021
Last Updated
last year
Study Type
Interventional
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • •Current participant inclusion criteria as of 19/02/2020:
  • •1\. Participant is willing and able to give informed consent for participation in the study
  • •2\. Screen positive for insomnia symptoms on the Sleep Condition Indicator (SCI) questionnaire AND meet criteria for insomnia disorder according to DSM\-5 (American Psychiatric Association) on structured checklist review
  • •3\. Sleep efficiency \< 85% over the past month
  • •4\. Age \=18 years
  • •5\. Able to attend appointments during baseline and 4\-week intervention (both face\-to\-face at the practice and over the phone) and adhere to study procedures
  • •6\. Registered at a GP practice taking part in the trial
  • •Previous participant inclusion criteria:
  • •1\. Participant is willing and able to give informed consent for participation in the study
  • •2\. Screen positive for insomnia symptoms on the Sleep Condition Indicator (SCI) questionnaire AND meet criteria for insomnia disorder according to DSM\-5 (American Psychiatric Association) on structured checklist review

Exclusion Criteria

  • •Current participant exclusion criteria as of 19/02/2020:
  • •1\. Pregnant/pregnancy planning in the next 6 months
  • •2\. Additional sleep disorder diagnosis (e.g., restless legs syndrome, obstructive sleep apnoea, narcolepsy) OR screen positive” on screening
  • •3\. Dementia/ Mild Cognitive Impairment (MCI)
  • •4\. Epilepsy
  • •5\. Psychosis (schizophrenia, bipolar disorder)
  • •6\. Current suicidal ideation with intent OR attempted suicide within past 2 months
  • •7\. Currently receiving cancer treatment OR planned major surgery during treatment phase
  • •8\. Night, evening, early morning or rotating shift\-work
  • •9\. Currently receiving psychological treatment for insomnia from a health professional

Outcomes

Primary Outcomes

Not specified

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