Targeting insomnia to treat depression: An explanatory randomised controlled trial of sleep restriction therapy

niversity of Oxford0 个研究点目标入组 250 人开始时间: 2023年4月12日最近更新: 2024年9月2日

适应症

试验速览

暂无简介。

•1. Participant is willing and able to give informed consent for participation in the trial.
•2. Aged 18 years or above.
•3. Screen positive for depressive symptoms on the PHQ-9 (> = 10) and meet criteria for Major Depressive Disorder, assessed via the Structured Clinical Interview for DSM-5 (SCID-5)
•4. Screen positive for insomnia symptoms on the sleep condition indicator and meet criteria for Insomnia Disorder
•5. Self-reported sleep efficiency < 85% over the past month, assessed via the Pittsburgh Sleep Quality Index (PSQI)
•6. Able to attend appointments for assessments and treatment and adhere to study procedures
•7. The participant’s GP surgery is participating in the trial

•1. Female participant who is pregnant or planning pregnancy during the trial
•2. Additional sleep disorder diagnosis OR positive” on screening.
•3. Dementia or Mild Cognitive Impairment (MCI)
•4. Alcohol or substance-use dependent
•5. Epilepsy
•6. Psychosis (schizophrenia, bipolar disorder)
•7. Currently or recently received in-patient psychiatric treatment within the past 2 months
•8. Current suicidal ideation with intent OR attempted suicide within the past 2 months
•9. Currently receiving cancer treatment OR planned major surgery during the treatment phase
•10. Night, evening, early morning or rotating shift-work
•11. Currently receiving psychological treatment for insomnia from a health professional or taking part in an online treatment programme for insomnia
•12. Previously received sleep restriction therapy from a health professional
•13. Life expectancy of < 1 year
•14. Another person in the household already participates in this trial
•15. Currently taking part in another clinical trial which could affect outcomes in RESTED
•16. Recruiting clinician deems not suitable for the trial

发起方