Efficacy of Group Cognitive Behavioural Therapy for Youth Anxiety and Insomnia

NCT ID: NCT06054243

Last Updated: 2023-09-26

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 171 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-17
• Study Completion Date: 2026-06-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

CBT-I

Group Type: EXPERIMENTAL

CBT-I

Intervention Type: 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-A

Group Type: ACTIVE_COMPARATOR

CBT-A

Intervention Type: 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).

Waiting-list control

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

CBT-I

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.

Intervention Type: BEHAVIORAL

CBT-A

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).

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chinese University of Hong Kong

OTHER

Sponsor Role: collaborator

Goldsmiths, University of London

OTHER

Sponsor Role: collaborator

Stanford University

OTHER

Sponsor Role: collaborator

The University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Dr. Shirley Xin Li

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shirley Xin Li, PhD, DClinPsy

Role: PRINCIPAL_INVESTIGATOR

The University of Hong Kong

Locations

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

Hong Kong, , Hong Kong

Site Status: RECRUITING

Countries

Hong Kong

Central Contacts

Shirley Xin Li, PhD, DClinPsy

Role: CONTACT

shirley.li@hku.hk

(852)39177035

Facility Contacts

Dr. Shirley X. Li

Role: primary

shirley.li@hku.hk

+852 3917-7035

Other Identifiers

EA210509

Identifier Type: -

Identifier Source: org_study_id