Group Cognitive Behavioural Therapy for Youth Anxiety and Insomnia

Efficacy of Group Cognitive Behavioural Therapy for Youth Anxiety and Insomnia: A Randomised, Assessor Blind, Parallel-group Trial

This study is testing a group therapy program for Chinese teens aged 12-20 to see if it can help them manage both anxiety and insomnia better.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 171 (estimated)
• Ages: 12 Years to 20 Years
• Sex: All
• Sponsor: The University of Hong Kong (other)
• Locations: 1 site (Hong Kong)
• Trial ID: NCT06054243 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of group cognitive behavioural therapy (CBT) specifically designed for adolescents experiencing anxiety and insomnia. It targets Chinese youth aged 12-20 who meet specific diagnostic criteria for insomnia and anxiety disorders. The intervention combines CBT for insomnia (CBT-I) and CBT for anxiety (CBT-A) to address the comorbidity of these conditions. The study aims to provide a structured therapeutic approach to improve mental health outcomes in this vulnerable population.

Who should consider this trial

Good fit: Ideal candidates for this study are Chinese adolescents aged 12-20 who suffer from insomnia and high levels of anxiety.

Not a fit: Patients with current substance abuse issues or severe psychiatric disorders may not benefit from this study.

Why it matters

Potential benefit: If successful, this intervention could significantly reduce anxiety and insomnia symptoms in adolescents, improving their overall mental health and quality of life.

How similar studies have performed: Previous studies have shown promising results for cognitive behavioural therapy in treating anxiety and insomnia, suggesting that this approach may be effective for the targeted population.

Eligibility criteria

Inclusion Criteria:

1. Chinese aged 12-20 years old (an age range that was suggested by scholars to cover a wider developmental span in adolescence);
2. Written informed consent of participation into the study is given by the participant and his/her parent or guardian (for those aged under 18);
3. Willing to comply with the study protocol;
4. 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 Criteria:

1. 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;
2. Having a prominent medical condition known to interfere with sleep continuity and quality (e.g. eczema, gastro-oesophageal reflux disease);
3. 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;
4. 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);
5. Having been enrolled in any other clinical trial investigational products within one month at the entry of the study;
6. 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;
7. Currently receiving any structured psychotherapy;
8. With hearing or speech deficit;
9. Night shift worker.

Where this trial is running

Hong Kong

• Sleep Research Clinic & Laboratory, Department of Psychology, The University of Hong Kong — Hong Kong, Hong Kong (RECRUITING)

Study contacts

• Principal investigator: Shirley Xin Li, PhD, DClinPsy — The University of Hong Kong
• Study coordinator: Shirley Xin Li, PhD, DClinPsy

Conditions: Insomnia, Anxiety, Adolescents, Youth