Insomnia Mental and Behavioural Disorders Disorders of initiating and maintaining sleep [insomnias]
Conditions
Interventions
Participants will be randomised (1:1) to one of the two intervention groups to receive either SRT+SH or SH, using a validated web-based randomisation programme (Sortition), with a non-deterministic mi
Sponsors
University of Oxford
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current participant inclusion criteria as of 19/02/2020: 1. Participant is willing and able to give informed consent for participation in the study 2. Screen positive for insomnia symptoms on the Sleep Condition Indicator (SCI) questionnaire AND meet criteria for insomnia disorder according to DSM-5 (American Psychiatric Association) on structured checklist review 3. Sleep efficiency < 85% over the past month 4. Age =18 years 5. Able to attend appointments during baseline and 4-week intervention (both face-to-face at the practice and over the phone) and adhere to study procedures 6. Registered at a GP practice taking part in the trial Previous participant inclusion criteria: 1. Participant is willing and able to give informed consent for participation in the study 2. Screen positive for insomnia symptoms on the Sleep Condition Indicator (SCI) questionnaire AND meet criteria for insomnia disorder according to DSM-5 (American Psychiatric Association) on structured checklist review 3. Sleep efficiency < 85% over the past month 4. Age =18 years 5. Able to attend appointments during baseline and 4-week intervention (both face-to-face at the practice and over the phone) and adhere to study procedures
Exclusion criteria
Exclusion criteria: Current participant exclusion criteria as of 19/02/2020: 1. Pregnant/pregnancy planning in the next 6 months 2. Additional sleep disorder diagnosis (e.g., restless legs syndrome, obstructive sleep apnoea, narcolepsy) OR screen “positive” on screening 3. Dementia/ Mild Cognitive Impairment (MCI) 4. Epilepsy 5. Psychosis (schizophrenia, bipolar disorder) 6. Current suicidal ideation with intent OR attempted suicide within past 2 months 7. Currently receiving cancer treatment OR planned major surgery during treatment phase 8. Night, evening, early morning or rotating shift-work 9. Currently receiving psychological treatment for insomnia from a health professional 10. Life expectancy of 3 nights during treatment phase 10. Currently receiving psychological treatment for insomnia from a health professional 11. Life expectancy of < 2 years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Self-rated insomnia severity using the insomnia severity index (ISI) questionnaire collected at baseline, 3, 6 and 12 months post randomization. Primary outcome is at 6 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 29/01/2021: 1. The effect of SRT+SH versus SH on health-related quality of life (HRQoL) measured using the SF-36 questionnaire (Mental component summary [MCS] score and Physical component summary [PCS] score) at baseline, 3, 6 and 12 months post-randomization 2. The effect of SRT+SH versus SH on subjective sleep. Subjective sleep recorded over 7 nights using the consensus sleep diary (CSD) (sleep-onset latency [SOL]; wake-time after sleep onset [WASO]; sleep efficiency [SE]; total sleep time [TST]; sleep quality [SQ]) at baseline, 6 and 12 months post-randomization 3. The effect of SRT+SH versus SH on object estimates of sleep. Actigraphy-recorded sleep over 7 nights (SOL; WASO; SE; TST) at baseline, 6 and 12 months post-randomization 4. The effect of SRT+SH versus SH on patient-generated quality of life. Self-rated quality of life using the Glasgow Sleep Impact Index [GSII Ranks 1,2,3] at baseline, 3, 6 and 12 months post-randomization 5. The effect of SRT+SH versus SH on depressive symptoms assessed by self-rated depressive symptoms severity measured using the Patient Health Questionnaire (PHQ-9) at baseline, 3, 6 and 12 months post-randomization. 6. The effect of SRT+SH versus SH on work productivity measured by the self-rated work productivity and activity impairment questionnaire (WPAI) at baseline, 3, 6 and 12 months post-randomization 7. The effect of SRT+SH versus SH on hypnotic medication use assessed by the use of prescribed hypnotics (quantified from 7-day diary) at baseline, 6 and 12 months post-randomization 8. The effect of SRT+SH versus SH on the use of other prescribed sleep-promoting medications measured by the use of other prescribed sleep-promoting medications (e.g., sedative antidepressants, antihistamines, antipsychotics, melatonin) quantified from 7 day diary, at baseline, 6 and 12 months post-randomization 9. The effect of SRT+SH versus SH on pre-sleep arousal and sleep effort measured by the pre-slee | — |
Countries
England, United Kingdom
Contacts
Public ContactBarbara Robinson
Outcome results
None listed