Evaluation of internet cognitive behavioural therapy for insomnia disorder

Completed

Conditions: Insomnia disorder
Mental and Behavioural Disorders
Nonorganic sleep disorders

Registration Number: ISRCTN44615689

Lead Sponsor: niversity of Glasgow (UK)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 156

Inclusion Criteria

1. Healthy participants from the community at large (18+ years, either sex)
2. Completed the on-line Great British Sleep Survey (www.sleepio.com)
3. Meet proposed Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV) criteria for insomnia disorder: complaint of poor sleep (difficulty initiating and/or maintaining sleep, early morning wakening, or non-restorative sleep), with daytime consequences for greater than or equal to 3 months

Exclusion Criteria

1. Possible significant mental (e.g. depression) or physical health problems (e.g. cardiovascular disease)
2. Disorders of sleep other than insomnia (e.g. sleep apnoea)
3. Dementia
4. Heavy alcohol use, excluded conservatively
5. Using online screening tools

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Sleep efficiency: this is the percentage of the time spend in bed that the person is asleep<br>2. Sleep Condition Indicator (SCI), a valid and reliable patient-reported outcome measure which is brief (8-item; range 0 - 32), valid (based on DSM-V) and reliable (a = 0.83). The SCI profiles daytime consequences of poor sleep and classifies clinical sleep status. Total <br>3. Derived sleep status category (very good, good, average, poor, very poor)<br>4. Measured at baseline, post-treatment evaluation and the 14 and 20 week follow-up evaluations

Secondary Outcome Measures

Name	Time	Method
1. Standard daily sleep diary data (e.g. sleep onset latency, wakeful time after sleep-onset)<br>2. Depression Anxiety and Stress Scales (DASS)<br>3. Sleep Disturbance Questionnaire (SDQ)<br>4. Content of Thoughts Inventory (CTI)<br>5. Sleep Effort Scale (SES)<br>6. Descriptive information on demographics and general physical and mental health, including alcohol use and lifestyle<br>7. CBT user experience and satisfaction<br>8. Adherence with treatment advice<br>9. Measured at baseline, post-treatment evaluation and the 14 and 20 week follow-up evaluations