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

NCT05270369 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 159

Last updated 2025-04-02

No results posted yet for this study

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

Interventions

BEHAVIORAL

digital CBTI

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

BEHAVIORAL

group CBTI

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

Sponsors & Collaborators

  • Chinese University of Hong Kong

    collaborator OTHER
  • University of Oxford

    collaborator OTHER
  • The University of Hong Kong

    lead OTHER

Principal Investigators

  • Shirley Xin Li, PhD,DClinPsy · The University of Hong Kong

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-01
Primary Completion
2024-11-30
Completion
2024-11-30

Countries

  • Hong Kong

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05270369 on ClinicalTrials.gov