Effect of digital Cognitive Behavioural Therapy for insomnia (dCBTi) in people with co-morbid insomnia and sleep apnoea: A randomised waitlist controlled trial.

Not Applicable

Active, not recruiting

Conditions: Insomnia disorder
Sleep Apnoea
Mental Health - Other mental health disorders
Respiratory - Sleep apnoea
Neurological - Other neurological disorders

Registration Number: ACTRN12622001218785

Lead Sponsor: Flinders University

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Active, not recruiting

Sex: All

Target Recruitment: 30

Inclusion Criteria

Patient Inclusion Criteria
1. Adults aged great than or equal to 18 years.
2. Reliable access to computer, tablet or smartphone, with internet access
3. Basic English language comprehension as required for dCBTi program
4. An ISI score of at least 15 (Moderate insomnia)
5. Previous doctor-diagnosed Sleep Apnoea (assessed via self-report)

Exclusion Criteria

1. Psychiatric condition (Bi-polar disorder, schizophrenia)
2. Risk of suicide (PHQ-9; item 9 score of greater than or equal to 1)
3. Epilepsy
4. Currently pregnant
5. Moderate daytime sleepiness (Epworth Sleepiness Scale score equal to or more than 16)
6. People who are commercial drivers or operate heavy machinery for work
7. People with a cognitive impairment
8. Shift workers
9. Previous diagnosis of a sleep disorder other than insomnia and sleep apnoea
10. Previous sleepiness-related motor-vehicle accident

Based on presenting symptoms, potential participants who are not eligible for this trial will be directed to a specialist Insomnia Treatment Program to access CBTi delivered by experienced 'sleep' Psychologists, their general practitioner, or alternative digital CBTi program.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Between-group change in self-reported insomnia severity on the Insomnia Severity Index (ISI) questionnaire.[ Between-group change in ISI scores from baseline to 8-week follow-up (primary timepoint). Change in ISI scores from baseline to 16-week and 24-week follow-up in the CBTi group.]

Secondary Outcome Measures

Name	Time	Method
Between-group change in self-reported depression symptoms on the Patient Health Questionnaire (PHQ-9).[ Between-group change in PHQ-9 scores from baseline to 8-week follow-up (primary timepoint). Change in PHQ-9 scores from baseline to 16-week and 24-week follow-up in the CBTi group.];Between-group change in self-reported anxiety symptoms on the Generalised Anxiety Disorder (GAD-7) questionnaire.[ Between-group change in GAD-7 scores from baseline to 8-week follow-up (primary timepoint). Change in GAD-7 scores from baseline to 16-week and 24-week follow-up in the CBTi group.]