Insomnia Mental and Behavioural Disorders Nonorganic sleep disorders
Conditions
Interventions
We will undertake a pilot cluster randomised controlled trial (RCT) in which general practices are the unit of randomisation and where data will be collected from patients. Recruited general medical p
intervention consisting of education of primary care teams to use problem focused therapy for insomnia comprising sleep assessment tools (sleep diaries and Insomnia Severity Index) and modified cognit
or a control arm using treatment as usual (TAU).
Patients will be involved in the study for a total of 13 weeks. Study outcomes will be measured at baseline, 4 weeks, 8 weeks and 13 weeks. Follow-up
Sponsors
Lincolnshire Primary Care Trust (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. At least 18 years old, either sex 2. Difficulty initiating and/or maintaining sleep for one month or more verified by Pittsburgh Sleep Quality Index (PSQI) score of greater than or equal to 5 3. New presentations with insomnia and existing patients on long term hypnotics 4. Points 1 - 3 above and sleep disrupted by painful conditions 5. Points 1 - 3 above and moderate/mild depression measured by the Beck Depression Inventory (BDI) (score 11 - 30)
Exclusion criteria
Exclusion criteria: 1. Current or previous illicit substance or alcohol abuse 2. Pregnant or planning pregnancy in the next 12 months 3. Psychotic illness and severe depression defined by a BDI score greater than or equal to 31 4. Documented or active symptoms of sleep disruptive comorbid conditions, e.g. restless legs syndrome and any type of parasomnia 5. Obstructive sleep apnoea 6. Terminal illness 7. Inability to consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Global sleep quality as measured by PSQI at 0, 4, 8 and 13 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| Measured at 0, 4, 8 and 13 weeks: 1. The effect of the intervention on sleep outcome measures assessed with PSQI and sleep diaries: 1.1. Self reported sleep onset latency (SOL): how long it takes to fall asleep 1.2. Wake time after sleep onset (WASO): total hours awake at night after one has fallen asleep 1.3. Total time in bed (TIB) 1.4. Sleep efficiency (SE). Sleep efficiency, expressed as a percentage, is calculated as follows: SE = (100- [(SOL + WASO/TIB) x 100]) 2. Daytime sleepiness (Epworth Sleepiness Scale) 3. Anxiety and depression using the generic Beck Depression Inventory 4. Health-related quality of life using EuroQol EQ-5D 5. Frequency of use and mean dose of hypnotic medication Patients will also keep a Data Record Book (DRB) to record any adverse effects that participants might experience during the treatment period. | — |
Countries
United Kingdom
Outcome results
None listed