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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN43900695
Enrollment
124
Registered
2020-04-08
Start date
2020-08-17
Completion date
Unknown
Last updated
2024-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute insomnia Mental and Behavioural Disorders

Interventions

Current interventions as of 28/07/2020: This is an interventional study where poor sleepers will be recruited to receive the intervention, or will be recruited as a wait-list control, where they will
good sleepers will be randomised to treatment or no treatment). The study is single-centre and the study will be run entirely online. Participants who are in the two intervention groups (poor sleep

Sponsors

Northumbria University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion 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

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)

Design outcomes

Primary

MeasureTime frame
Current primary outcome measure as of 28/07/2020: Insomnia severity measured using the Insomnia Severity Index prior to the intervention and 1 week, 1 month and 3 months post-intervention, relative to baseline Previous primary outcome measure: Insomnia severity measured using the Insomnia Severity Index at one week post-intervention

Secondary

MeasureTime frame
Current secondary outcome measures as of 28/07/2020: 1. Subjective mood measured using the PHQ-9 and GAD-7 immediately prior to the intervention, 1 week, 1 month and 3 months post-intervention, compared to baseline 2. Sleep continuity measured using sleep diaries 1-week pre-intervention and 1-week post-intervention Previous secondary outcome measures: 1. Sleep continuity from sleep diaries throughout the intervention 2. Subjective mood measured using the PHQ-9 and GAD-7 at 1-week post-intervention

Countries

England, United Kingdom

Contacts

Public ContactGreg Elder
g.elder@northumbria.ac.uk+44 (0)191 227 3241

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 26, 2026