Comparison of the Effects of Support and Non-support Online CBT-I
NCT ID: NCT05011929
Last Updated: 2022-02-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
90 participants
INTERVENTIONAL
2019-12-10
2022-12-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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online CBT-I with support (individualized feedback and reminders)
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.
Cognitive behavioral therapy
refer to the arm description
online CBT-I without support
same as the experimental arm but without reminders and individualized feedback
Cognitive behavioral therapy
refer to the arm description
Interventions
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Cognitive behavioral therapy
refer to the arm description
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
12 Years
24 Years
ALL
No
Sponsors
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Chinese University of Hong Kong
OTHER
The University of Hong Kong
OTHER
Responsible Party
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Dr. Shirley Xin Li
Assisitant Professor
Principal Investigators
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Shirley Xin Li, PhD
Role: PRINCIPAL_INVESTIGATOR
The University of Hong Kong
Locations
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Sleep Research Clinic & Laboratory, Department of Psychology, The University of Hong Kong
Hong Kong, , Hong Kong
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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EA
Identifier Type: -
Identifier Source: org_study_id
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