Status:
RECRUITING
Efficacy of Group Cognitive Behavioural Therapy for Youth Anxiety and Insomnia
Lead Sponsor:
The University of Hong Kong
Collaborating Sponsors:
Chinese University of Hong Kong
Goldsmiths, University of London
Conditions:
Insomnia
Anxiety
Eligibility:
All Genders
12-20 years
Phase:
NA
Brief Summary
Youth is an important transitional stage associated with dynamic changes in biological, cognitive, and psychological functioning, as well as a constellation of developmental and psychosocial challenge...
Eligibility Criteria
Inclusion
- Chinese aged 12-20 years old (an age range that was suggested by scholars to cover a wider developmental span in adolescence);
- Written informed consent of participation into the study is given by the participant and his/her parent or guardian (for those aged under 18);
- Willing to comply with the study protocol;
- Meeting the DSM-5 diagnostic criteria of insomnia disorder and with a score on Insomnia Severity Index (ISI) \>= 9 (suggested cut-off for adolescents); 5) Presenting with a high level of anxiety symptoms as defined by a total score \>32 and \>37 for males and females respectively on Spence Children's Anxiety Scale (SCAS).
Exclusion
- 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 (other than insomnia) that may potentially contribute to a disruption in sleep continuity and quality, such as narcolepsy, sleep-disordered breathing, and restless leg syndrome, as ascertained by the DISP, a validated structured diagnostic interview to assess major sleep disorders according to the ICSD criteria;
- Concurrent, regular use of medications(s) known to affect sleep continuity and quality including both western medications (e.g. hypnotics, steroids) and over-the-counter OTC medications (e.g. melatonin, Traditional Chinese Medicine, TCM);
- Having been enrolled in any other clinical trial investigational products within one month at the entry of the study;
- Having a clinically significant suicidality (presence of suicidal ideation with a plan or an attempt) as assessed confirmed by research clinician using the MINI Suicidality Module;
- Currently receiving any structured psychotherapy;
- With hearing or speech deficit;
- Night shift worker.
Key Trial Info
Start Date :
February 17 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2026
Estimated Enrollment :
171 Patients enrolled
Trial Details
Trial ID
NCT06054243
Start Date
February 17 2023
End Date
June 30 2026
Last Update
September 26 2023
Active Locations (1)
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1
Sleep Research Clinic & Laboratory, Department of Psychology, The University of Hong Kong
Hong Kong, Hong Kong