Efficacy of Group Cognitive Behavioural Therapy for Youth Anxiety and Insomnia (NCT06054243) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Efficacy of Group Cognitive Behavioural Therapy for Youth Anxiety and Insomnia
Hong Kong171 participantsStarted 2023-02-17
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 range12 Years – 20 Years
SexALL
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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;
✕. 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;
What they're measuring
1
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
2
Change of insomnia symptoms
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
✕. 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;
✕. Currently receiving any structured psychotherapy;