Online Insomnia Treatment in Australian General Practice

Not Applicable

Recruiting

• Conditions: Insomnia; Public Health - Health service research; Neurological - Other neurological disorders

• Registration Number: ACTRN12619001539123
• Lead Sponsor: The Adelaide Institute for Sleep Health, Flinders University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-11-07
• Last Update Posted: 1 February 2021

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 375

Inclusion Criteria

General Practitioner Inclusion Criteria;
1. Currently using the Doctors Control Panel software

Patient Inclusion Criteria
1. Age > 18 years.
2. Reliable access to computer, tablet or smartphone, with internet access
3. Basic English language comprehension as required for Sleepio.

Group 1 New Insomnia - No GP prescriptions of Temazepam, Oxazepam, Nitrazepam, Zolpidem, Zopiclone, or Melatonin in the past 12 months,

Group 2 Single Sleeping Pill Prescription - One GP prescription of Temazepam, Oxazepam, Nitrazepam, Zolpidem, Zopiclone, or Melatonin in the past 12 months,

Group 3 Repeat Sleeping Pill Prescriptions - Any combination of two or more GP prescriptions of Temazepam, Oxazepam, Nitrazepam, Zolpidem, Zopiclone, or Melatonin in the past 12 months.

Exclusion Criteria

Patient Exclusion Criteria (assessed by treating GPs, according to RACGP/Sleepio recommendations);
1. Drug or alcohol problems
2. Terminal illness
3. Acute crisis
4. Risk of suicide
5. Severe mental illness
6. Organic brain disease
7. Epilepsy requiring benzodiazepine as part of anticonvulsant therapy
8. Benzodiazepine prescriptions for muscle spasms
9. Women who are currently pregnant

Patient Exclusion Criteria (Assessed via online self-reported screening questionnaire):
1. Any previous diagnosis of Obstructive Sleep Apnea, Restless Legs Syndrome, or REM Behaviour Disorder.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in number of sleeping pill prescriptions (assessed via data linkage to MBS/PBS data, for prescriptions of Benzodiazepines, 'z-drugs', and Melatonin) in patients recruited to the trial.[Change in number of sleeping pill prescriptions from the 12-month period preceding trial recruitment to the 12-month period following recruitment to the trial.];Change in the number of self-reported sleeping pills consumed in patients recruited to the trial.[Change in the self-reported number of sleeping pills consumed in the last two weeks at pre-treatment, 8-weeks, 6-months, and 12-months follow-up.];Change in self-reported Insomnia Severity Index scores in patients recruited to the trial[Change in Insomnia Severity Index scores from pre-treatment, to 8-week, 6-month, and 12-month follow-up.]