Efficacy of Group Cognitive Behavioural Therapy for Youth Anxiety and Insomnia

NCT06054243 | Active Not Recruiting

• 1 other identifier: EA210509
• Study Type: interventional
• Target: 171
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Insomnia; Anxiety

Keywords

Insomnia; Anxiety; Adolescents; Youth

Outcome Measures

Primary Outcomes (2)

• Change of anxiety symptoms (assessor-rated)

  Pediatric Anxiety Rating Scale (PARS) is a clinician-rated scale commonly used in the clinical studies on anxiety conducted in adolescents. Possible scores range from 0 to 35, with higher scores indicating severer anxiety symptoms.

  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

  Insomnia Severity Index (ISI) is a 7-item self-rated scale. Possible scores range from 0 to 20, with higher scores indicating greater insomnia severity.

  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

Secondary Outcomes (36)

• Change of sleep quality

  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 sleep diary measure (time in bed, TIB)

  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 sleep diary measure (total sleep time, TST)

  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 sleep diary measure (sleep onset latency, SOL)

  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 sleep diary measure (wake after sleep onset, WASO)

  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

Study Arms (3)

CBT-I

EXPERIMENTAL

Behavioral: CBT-I

CBT-A

ACTIVE COMPARATOR

Behavioral: CBT-A

Waiting-list control

NO INTERVENTION

Interventions

CBT-I BEHAVIORAL

The intervention will consist of eight weekly group sessions (120-min, 5-8 adolescents in each group) delivered within a 10-week windows. The treatment components aim to address the behavioural, cognitive and physiological factors perpetuating insomnia whilst considering the sleep and circadian features in adolescents and developmental context with the following key elements: psychoeducation about sleep, circadian rhythm and sleep hygiene, stimulus control, sleep restriction, relaxation training, structured worry time, cognitive restructuring (targeting sleep-related dysfunctional cognitions), and relapse prevention.

CBT-I

CBT-A BEHAVIORAL

The intervention will consist of eight weekly group sessions (120-min, 5-8 adolescents in each group) delivered within a 10-week windows. The CBT-A treatment is modified from the Coping Cat programme, which incorporates psychoeducation and the core behavioural strategies and cognitive skills for managing anxiety (e.g. exposure, relaxation training, cognitive restructuring).

CBT-A

Eligibility Criteria

• Age: 12 Years - 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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;
• Currently receiving any structured psychotherapy;
• With hearing or speech deficit;
• Night shift worker.

Sponsors & Collaborators

• The University of Hong Kong: lead
• Chinese University of Hong Kong: collaborator
• Goldsmiths, University of London: collaborator
• Stanford University: collaborator

Study Sites (1)

Sleep Research Clinic & Laboratory, Department of Psychology, The University of Hong Kong

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Anxiety Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Shirley Xin Li, PhD, DClinPsy

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 19, 2023
• First Posted: September 26, 2023
• Study Start: February 17, 2023
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: April 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)