Comparison of the Effects of Support and Non-support Online CBT-I

  • STATUS
    Recruiting
  • days left to enroll
    57
  • participants needed
    90
  • sponsor
    The University of Hong Kong
Updated on 22 March 2022
behavior therapy

Summary

Insomnia is the most prevalent sleep problem in children and adolescents and it has been found to predict the development of mental health problems in young adulthood. Cognitive behavioral therapy for insomnia (CBT-I) has been found to be effective in both adults and adolescents. However, limited accessibility and availability of the treatment has only benefited a small proportion of insomnia patients. Therefore, digital CBT-I has been promoted as an alternative way to manage individual's insomnia problems with adequate efficacy. Nonetheless, one of the major limitations of the online self-help intervention is the relatively high drop-out rate and lower compliance compared to the face-to-face modality which the interactive component is less practical in the online intervention. Therefore, the objectives of current study are 1) evaluate the efficacy of mobile-APP based CBT-I in treating youth insomnia, 2) evaluate whether the provision of additional support could further enhance the treatment outcomes.

Details
Condition Insomnia
Treatment Cognitive behavioral therapy
Clinical Study IdentifierNCT05011929
SponsorThe University of Hong Kong
Last Modified on22 March 2022

Eligibility

Yes No Not Sure

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
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