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

Not Applicable

Completed

Conditions: Acute insomnia
Mental and Behavioural Disorders

Registration Number: ISRCTN43900695

Lead Sponsor: orthumbria University

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)

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 344

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)

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Current primary outcome measure as of 28/07/2020:<br>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<br><br>Previous primary outcome measure:<br>Insomnia severity measured using the Insomnia Severity Index at one week post-intervention

Secondary Outcome Measures

Name	Time	Method
Current secondary outcome measures as of 28/07/2020:<br>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<br>2. Sleep continuity measured using sleep diaries 1-week pre-intervention and 1-week post-intervention<br><br>Previous secondary outcome measures:<br>1. Sleep continuity from sleep diaries throughout the intervention<br>2. Subjective mood measured using the PHQ-9 and GAD-7 at 1-week post-intervention