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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 12
Maximum Age: 20
Healthy Volunteers: f
View:

• 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).

Locations
Other Locations
Hong Kong Special Administrative Region
Sleep Research Clinic & Laboratory, Department of Psychology, The University of Hong Kong
RECRUITING
Hong Kong
Contact Information
Primary
Shirley Xin Li, PhD, DClinPsy
shirley.li@hku.hk
(852)39177035
Time Frame
Start Date: 2023-02-17
Estimated Completion Date: 2026-06-30
Participants
Target number of participants: 171
Treatments
Experimental: CBT-I
Active_comparator: CBT-A
No_intervention: Waiting-list control
Related Therapeutic Areas
Sponsors
Collaborators: Goldsmiths, University of London, Stanford University, Chinese University of Hong Kong
Leads: The University of Hong Kong

This content was sourced from clinicaltrials.gov