The effects of a sleep robot intervention on sleep, depression, and anxiety in adults with insomnia
Not Applicable
Completed
- Conditions
- InsomniaMental and Behavioural Disorders
- Registration Number
- ISRCTN35134834
- Lead Sponsor
- Karlstad University
- Brief Summary
2021 Protocol article in https://pubmed.ncbi.nlm.nih.gov/34610481/ (added 31/10/2022) 2022 Results article in https://doi.org/10.1111/jsr.13758 (added 31/10/2022) 2023 Results article in https://doi.org/10.2147/NSS.S408714 (added 06/08/2024)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 44
Inclusion Criteria
Meets the DSM-5 diagnostic criteria for insomnia disorder as measured by clinical evaluation by a licensed psychologist using the Insomnia severity index (ISI) and the Duke structured clinical interview for sleep disorders (DSISD)
Exclusion Criteria
1. Does not speak Swedish
2. Aged <18 years
3. Meet the criteria for another sleep disorder which they are not adequately treated for
4. Meet the diagnostic criteria for a medical or psychiatric condition that may explain the symptoms of insomnia
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Insomnia measured with the Insomnia Severity Index at baseline, 10, and 24 days
- Secondary Outcome Measures
Name Time Method 1. Pre-sleep arousal measured with the total score of the Pre-Sleep Arousal Scale at baseline, and 24 days<br>2. Symptoms of anxiety and depression measured with the total scores from the anxiety and depression scales of the Hospital Anxiety and Depression Scale at baseline, and 24 days<br>3. Sleep parameters measured with sleep diaries and actigraphy where the values from both will be averaged over a week to compute single summary scores for each of the relevant variables, for the periods -7 to 0 days and 14 to 21 days