Research and Evaluation Study of digital Treatment of insomnia in Underserved Populations (REST UP)

Not Applicable

Not yet recruiting

• Conditions: Insomnia; Mental Health - Other mental health disorders; Neurological - Other neurological disorders

• Registration Number: ACTRN12624001196538
• Lead Sponsor: Department of Health and Aged Care - Medical Research Future Fund (MRFF)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2024-09-30
• Last Update Posted: 30 September 2024

Recruitment & Eligibility

• Status: Not yet recruiting
• Sex: All
• Target Recruitment: 405

Inclusion Criteria

General practitioner inclusion criteria;1. Currently practicing as a general practitioner in Australia.Patient inclusion criteria;1. Aged at least 18 years2. Referred by a participating general practitioner, according to GP-identified insomnia symptoms, general practice electronic medical record notes identifying diagnosis or clinical problem of insomnia lasting at least 3 months, and/or prescription of sedatives or hypnotics for insomnia symptoms3. Reliable access to a computer, tablet, or smartphone with internet access.4. Basic English language comprehension as required for CBTi program participation.5. Active patients of the participating general practice clinic (have attended at least 3 times in the last two years).6. Insomnia symptoms according to an Insomnia Severity Index score of at least 15, that have persisted for at least 3 months (indicative of chronic insomnia)

Exclusion Criteria

1. Doctor-diagnosed sleep disorders other than insomnia (e.g. sleep apnoea, narcolepsy).2. Excessive daytime sleepiness (Epworth Sleepiness Scale Score >15).3. Current psychological treatment for insomnia, 4. Shift work within the past 3 months, 5. Significant cognitive impairment, terminal illness, severe psychiatric condition (e.g., bipolar disorder or schizophrenia disorder), or epilepsy.6. Currently pregnant.7. Previous sleepiness-related motor-vehicle accident.8. Driver, pilot, or operates heavy machinery for work.9. No self-reported risk of self-harm (identified by a score of greater than or equal to 1 on the PHQ-9, item 9).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Insomnia Severity Index (ISI) questionnaire.<br><br>[Between-group change in self-reported insomnia severity on the Insomnia Severity Index (ISI) questionnaire. Between-group change in ISI scores from baseline to 10-weeks and 6-month follow-up post-randomisation.]

Secondary Outcome Measures

Name	Time	Method
Depressive symptoms.[Between-group change in self-reported depressive symptoms on the Patient Health Questionnaire (PHQ-9). Between-group change in PHQ-9 scores from baseline to 10-weeks and 6-month follow-up post-randomisation.];Use of medicines for insomnia (Assessed as a composite secondary outcome including prescription and over-the-counter medicines for insomnia).[Self-reported use of sedative-hypnotic, and over-the-counter medicines used for insomnia in the previous month. Assessed via self-report during online questionnaire batteries. Between-group difference in self-reported use of medicines for insomnia (binary outcome) at 10-weeks and 6-month follow-up post-randomisation.]