Comparison of the Effects of Support and Non-support Online CBT-I
Insomnia
About this trial
This is an interventional treatment trial for Insomnia
Eligibility Criteria
Inclusion Criteria:
- Chinese aged 12-24 years old;
- Informed consent of participation into the study is given by the participant and his/her parent or guardian (for those aged under 18);
- Being able to comply with the study protocol;
- Having a DSM-5 diagnosis of insomnia disorder, with a score on Insomnia Severity Index (ISI) >= 9 (suggested cut-off for adolescents)
Exclusion Criteria:
- A current diagnosis of substance abuse or dependence; a current or past history of manic or hypomanic episode, schizophrenia spectrum disorders, neurodevelopmental disorders, organic mental disorders, or intellectual disabilities;
- Having a prominent medical condition known to interfere with sleep continuity and quality (e.g. eczema, gastro-oesophageal reflux disease);
- Having a clinically diagnosed sleep disorder that may potentially contribute to a disruption in sleep continuity and quality, such as narcolepsy, sleep-disordered breathing, and restless leg syndrome;
- Concurrent, regular use of medications(s) known to affect sleep continuity and quality (e.g. hypnotics, steroids);
- In the opinion of the research clinician, having a clinically significant suicidality (presence of suicidal ideation with a plan or an attempt);
- Having been enrolled in any other clinical trial investigational products within one month at the entry of the study;
- Initiation of or change in antidepressant medication within past 2 months;
- Having been or is currently receiving any structured psychotherapy;
- With hearing or speech deficit;
- Night shift worker.
Sites / Locations
- Sleep Research Clinic & Laboratory, Department of Psychology, The University of Hong KongRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
online CBT-I with support (individualized feedback and reminders)
online CBT-I without support
The mobile-APP based CBT-I consists of 6 weekly session. The treatment is structured and based on the well-established CBT elements for treating insomnia. The treatment components in the CBT-I aim to address the behavioural, cognitive and physiological perpetuating factor of insomnia and include: psycho-education about sleep and sleep hygiene, stimulus control, sleep restriction, relaxation training, structured worry time, cognitive restructuring (targeting sleep-related dysfunctional cognitions), and relapse prevention. reminders and individualized feedback regarding the behavioral strategies will be sent to the participant every week.
same as the experimental arm but without reminders and individualized feedback