INvestigating the Value of Early Sleep Therapy

NANot yet recruitingINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

April 1, 2024

Primary Completion Date

June 1, 2025

Study Completion Date

June 1, 2025

Conditions
Acute Insomnia (Disorder)
Interventions
BEHAVIORAL

Sleep Restriction Therapy (SRT)

SRT is a manualised, adaptive, behavioural insomnia intervention that is a key active ingredient within multi-component CBT-I. Our SRT protocol involves standardising and (where required) limiting a patient's time in bed with the aim of increasing homeostatic sleep pressure, over-riding cognitive and physiological arousal, and strengthening circadian control of sleep. Those randomised to the SRT arm will receive two online sessions supported by two telephone calls over a 4-week intervention phase. The intervention will be delivered by trained research nurses

BEHAVIORAL

Sleep Hygiene Education (SHE)

SHE will be delivered via a booklet that provides information about lifestyle changes (e.g., reducing exercise in the evening, light snack before bedtime, reducing caffeine) and changes to the bedroom environment (e.g., dark room, comfortable mattress, optimal room temperature). Patients in the SHE condition will be instructed to implement the SHE advice over a 4-week period. One week after randomisation to SHE, the RA will telephone patients to check they understand the SHE advice and answer any questions they may have. SHE has successfully been used as a control condition in other trials evaluating SRT and does not have any therapeutic benefit for individuals with insomnia but is often part of usual care, so is a credible alternative to SRT.

All Listed Sponsors
collaborator

University of Oxford

OTHER

collaborator

University of Glasgow

OTHER

collaborator

NHS Greater Glasgow and Clyde

OTHER

collaborator

NHS Grampian

OTHER_GOV

lead

University of Strathclyde

OTHER

NCT06294041 - INvestigating the Value of Early Sleep Therapy | Biotech Hunter | Biotech Hunter