CompletedNot Applicable

Efficacy of Group Cognitive Behavioural Therapy for Youth Anxiety and Insomnia

Hong Kong137 participantsStarted 2023-03-22

Plain-language 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 challenges. In particular, anxiety disorders constitute the most common mental health problems in youth, with a prevalence rate up to 32%. Youth anxiety is associated with not only profound personal distress, but also considerable impairments in psychosocial functioning and an increased risk for developing other psychiatric comorbidities (e.g. depression, substance use). Meanwhile, sleep problems, particularly insomnia, are also common in the teen years, with a prevalence rate as high as 36%. Insomnia and anxiety are highly comorbid conditions, with increasing evidence suggesting their intricate, bidirectional relationship, such as a high level of anxiety symptoms found in youth with insomnia. However, optimal treatment strategies to manage the comorbidity of these two conditions remain uncertain. This study will test the efficacy of group-based cognitive behavioural therapy for insomnia (CBT-I) and cognitive behavioural therapy for anxiety (CBT-A) in reducing the severity of insomnia and anxiety symptoms in youth with comorbid insomnia and anxiety, as well as their effects on depressive symptoms, daytime functioning (e.g. sleepiness, fatigue), subjective and objective sleep measures.

Who can participate

Age range

12 Years – 20 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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 in 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 the 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 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;

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change of anxiety symptoms (assessor-rated)

Timeframe: Baseline, post-treatment (one-week after completion of the intervention/waiting period) for all participants; and additional two follow-ups at Post-Treatment 1-month and Post-Treatment 6-month for participants in the treatment groups

Change of insomnia symptoms

Trial details

NCT IDNCT06054243

SponsorThe University of Hong Kong

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-12-09

View on ClinicalTrials.gov More Insomnia trials