Digital insomnia therapy to assist your life as well as your sleep

Not Applicable

Completed

• Conditions: Insomnia disorder; Disorders of initiating and maintaining sleep [insomnias]; Nervous System Diseases

• Registration Number: ISRCTN60530898
• Lead Sponsor: niversity of Oxford (UK)

Brief Summary

2016 Protocol article in http://www.ncbi.nlm.nih.gov/pubmed/27216112 protocol 2019 Results article in https://www.ncbi.nlm.nih.gov/pubmed/30264137 results 2020 Results article in https://www.ncbi.nlm.nih.gov/pubmed/32112507 results (added 02/03/2020) 2022 Other publications in https://pubmed.ncbi.nlm.nih.gov/36216367/ Secondary analysis of effects on QALYs (added 11/10/2022) 2022 Other publications in https://pubmed.ncbi.nlm.nih.gov/36527942/ Interaction between symptopms and impairment (added 19/12/2022)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-12-04
• Study Completion: 2017-07-01
• Last Update Posted: 9 January 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 1711

Inclusion Criteria

1. A positive screen for probable DSM-5 insomnia disorder
2. A test score of =16 on the Sleep Condition Indicator
3. Being aged 18 or older (no upper age limit)
4. Having reliable internet access at home or at work
5. Being able to read and understand English

Exclusion Criteria

We will screen for comorbid conditions and medication use at baseline but exclude only those people whose health may be considered to be unstable such as significant current symptoms of:
1. An additional sleep disorder (e.g., excessively sleepy and possible obstructive sleep apnea)
2. Psychosis or mania
3. Serious physical health concerns necessitating surgery or with prognosis <6 months
4. Those undergoing a psychological treatment programme for insomnia with a health professional
5. Habitual night shift, evening, or rotating shift-workers.
We will not omit participants who take medication for sleep problems, or for any other physical or mental health problems providing they report their health to be stable.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 1. Functional health and wellbeing: Global Health scale (PROMIS-10, Hays et al, 2009)<br> 2. Psychological wellbeing: Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS, Tennant et al, 2007)<br> 3. Sleep-related quality of life: Glasgow Sleep Impact Index (GSII, Kyle et al 2013)<br> All these measures will be taken at baseline, 4 weeks, 8 weeks, 24 weeks, 36 weeks and 48 weeks.<br>

Secondary Outcome Measures

Name	Time	Method
<br> 1. Mood: Patient Health Questionnaire (PHQ9, Kroenke, Spitzer & Williams, 2010) and Generalised Anxiety Disorder (GAD, Spitzer, Kroenke & Williams, 2006)<br> 2. Energy: Flinders Fatigue Scale (FSS, Gradisar et al., 2007)<br> 3. Relation satisfaction: Relation Assessment Scale (RAS, Hendrick et al., 1988)<br> 4. Cognitive status: Cognitive Failures Questionnaire (CFQ, Broadbent, 1982)<br> 5. Work performance and satisfaction: Work and Productivity and Activity Impairment Questionnaire (WPAI, Reilly et al., 1993) and 1 item about job satisfaction (Dolbier et al., 2005)<br> 6. Sleepiness: Epworth Sleepiness Scale (ESS, Johns, 1991)<br> 7. Life satisfaction (1 item, Cheung et al, 2014)<br> 8. Sleep improvement: Sleep Condition Indicator (SCI, Espie et al, 2014)<br> All these measures will be taken at baseline, 4 weeks, 8 weeks, 24 weeks, 36 weeks and 48 weeks.<br>