Effects of Group-based and Digitally Delivered CBT-I in Youth

NCT05270369 | Completed

• 1 other identifier: EA200037
• Study Type: interventional
• Target: 159
• Locations: 1 country
• Sites: 1

Brief Summary

Adolescence is a critical transitional stage characterised by a cascade of developmental changes in biological, cognitive, and psychological functioning. Sleep problems, particularly insomnia, are prevalent in adolescents, with a prevalence rate as high as 36%. Insomnia symptoms, presented as the problems initiating sleep or maintaining sleep, have often been reported in association with adverse outcomes in adolescents, including an increased risk of developing depression, anxiety, interpersonal problems, somatic health problems, self-harm and suicidal ideation. This study tests the efficacy of cognitive behavioural therapy for insomnia (CBT-I) in reducing insomnia severity in youth with insomnia.

Conditions

Insomnia

Keywords

youth; sleep; insomnia; CBT-I

Outcome Measures

Primary Outcomes (1)

• Change of insomnia symptoms

  Insomnia symptoms measured by Insomnia Severity Index (ISI). ISI is a 7-item self-rated scale. Possible scores range from 0 to 28, with higher scores indicating higher 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 6-month and Post-Treatment 12-month for participants in the treatment groups

Secondary Outcomes (38)

• Change in 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 6-month and Post-Treatment 12-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 6-month and Post-Treatment 12-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 6-month and Post-Treatment 12-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 6-month and Post-Treatment 12-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 6-month and Post-Treatment 12-month for participants in the treatment groups

Study Arms (3)

digital cognitive behavioural therapy for insomnia (CBTI)

EXPERIMENTAL

The digital CBTI group will receive 6-session on their smartphone application

Behavioral: digital CBTI

group cognitive behavioural therapy for insomnia (CBTI)

EXPERIMENTAL

The group CBTI will receive 6-session CBTI in group

Behavioral: group CBTI

waitlist

NO INTERVENTION

The waitlist group will receive treatment sessions after about 10 weeks' time

Interventions

digital CBTI BEHAVIORAL

The app-based intervention will consists of 6 weekly sessions and will be delivered within a 10-week window. 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: psycho-education 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

digital cognitive behavioural therapy for insomnia (CBTI)

group CBTI BEHAVIORAL

The group-based CBT-I intervention will consist of 6 weekly sessions (90-min, 5-8 adolescents in each group) and will be delivered within a 10-week window. 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: psycho-education 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

group cognitive behavioural therapy for insomnia (CBTI)

Eligibility Criteria

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

You may qualify if:

• (1) Chinese aged 12-20 years old (an age range that was similarly adopted in the previous studies 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 Diagnostic and Statistical Manual of Mental Disorders (DSM-5) diagnostic criteria of insomnia disorder and with a score on Insomnia Severity Index (ISI) - 9 (suggested cut-off for adolescents)

You may not qualify if:

• (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 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 Structured Interview for Sleep Patterns and Disorders (DISP), a validated structured diagnostic interview to assess major sleep disorders according to the International Classification of Sleep Disorder (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) In the opinion of the research clinician, having a clinically significant suicidality (presence of suicidal ideation with a plan or an attempt) as assessed by Mini-International Neuropsychiatric Interview (MINI);
• (7) Currently receiving any structured psychotherapy;
• (8) With hearing or speech deficit; (9) Night shift worker.

Sponsors & Collaborators

• The University of Hong Kong: lead
• Chinese University of Hong Kong: collaborator
• University of Oxford: collaborator

Study Sites (1)

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

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance 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: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 14, 2022
• First Posted: March 8, 2022
• Study Start: January 1, 2022
• Primary Completion: November 30, 2024
• Study Completion: November 30, 2024
• Last Updated: April 2, 2025

Record last verified: 2025-03

Locations

HK (1)