Insomnia disorder Mental and Behavioural Disorders
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adult members from the general population who meet the DSM-5 criteria for Insomnia Disorder 2. Dissatisfaction with sleep characterized by either a difficulty initiating or maintaining sleep or early morning awakenings 3. Insomnia should be present for three or more nights per week, for at least three months, and cause significant daytime impairment 4. These conditions must be met despite an adequate opportunity to sleep
Exclusion criteria
Exclusion criteria: 1. Symptoms of a sleep/wake disorder other than insomnia 2. Existing psychiatric illness 3. Central nervous system disorder 4. Use of medication that may affect sleep 5. Prior head injury 6. Current shift-work
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome measure as of 25/09/2018: 1. Sleep-related attentional bias (i.e. vigilance, disengagement) assessed using a dot-probe task consisting of sleep-negative and neutral words at baseline (day1) and then again on day 9 2. Insomnia severity measured by the Insomnia Severity Index at baseline (day 1), on completion of experimental protocol (day 9), and on day 16 3. Sleep onset latency measured by a sleep diary at baseline (day 1) and on completion of experimental protocol (day 9) 4. Pre-sleep cognitive arousal measured by the Pre-Sleep Cognitive Arousal Scale prior to sleep on days where the experiment will be administered (days 3-7) Previous primary outcome measure: 1. Sleep-related attentional bias (i.e. vigilance, disengagement) assessed using a dot-probe task consisting of sleep-negative and neutral words at baseline (day1) and then again on day 9 2. Insomnia severity measured by the Insomnia Severity Index at baseline (day 1), on completion of experimental protocol (day 9), and on day 16 3. Sleep onset latency measured by a sleep diary at baseline (day 1) and on completion of experimental protocol (day 9) 4. Pre-sleep cognitive arousal measured by the Pre-Sleep Cognitive Arousal Scale prior to sleep on days where the experiment will be administered (day 3, 5 and 7) | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety and monitoring behavior, assessed using the SAMI at baseline (day 1), 9 and 16 | — |
Countries
United Kingdom