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Effectiveness of Digital CBT-I and BT-I combined ACT for Insomnia and Anxiety Symptoms in Youth: A Randomised Control Trial

Effectiveness of Digital Cognitive Behavioral Therapy for Insomnia (CBT-I) and BT-I Combined with Acceptance and Commitment Therapy (ACT) for Insomnia and Anxiety Symptoms in Youth: A Randomized Controlled Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500113086
Enrollment
Unknown
Registered
2025-11-24
Start date
2025-11-24
Completion date
Unknown
Last updated
2025-12-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Insomnia and anxiety

Interventions

Digital behavioral therapy for insomnia group:Treatment content is based on the well-established CBT-I manual with adaptation to the adolescent and youth population. The content of dCBT-I consists of
Digital behavioral therapy for insomnia combined with acceptance commitment therapy group:dBT-I-ACT integrated components from acceptance and commitment therapy into the core behavioural strategies fo
Digital health education goup:Health Education is served as an active control. It aims at providing an overview on how to achieve health from physiological and psychological perspective. The content r

Sponsors

The Chinese University of Hong Kong
Lead Sponsor

Eligibility

Sex/Gender
All
Age
15 Years to 24 Years

Inclusion criteria

Inclusion criteria: i.Chinese youth aged 15-24 years old, ii.Presence of acute insomnia disorder as determined by validated Diagnostic Interview for Sleep Patterns and Disorders (DISP), iii.Presence of anxiety features as defined by General Anxiety Disorder-7 (GAD-7) using cut-off of 15 for detecting moderate anxiety symptoms, iv.Ability to listen, speak, and read Chinese and Cantonese, and v.Written informed consent of participation into the study is given by youth and his/her parent’s if under 18 years old; In addition, individual assent will also be obtained for subjects under age 18 years old vi.Possession of a smartphone

Exclusion criteria

Exclusion criteria: i.A clinical diagnosis of psychosis, schizophrenia, bipolar disorders, or intellectual disability, ii.Having a diagnosed sleep disorder (e.g. delayed sleep phase and narcolepsy) that may potentially contribute to the disruption of sleep quantity and quality as determined by validated Diagnostic Interview for Sleep Patterns and Disorders (DISP), iii.Having a clinically significant suicidality (presence of suicidal ideation with a plan or an attempt) as assessed by The Structured Clinical Interview (SCID), and iv.Currently receiving psychological treatment and/or pharmacological treatment for insomnia or anxiety disorder.

Design outcomes

Primary

MeasureTime frame
Hamilton Anxiety Rating Scale Score;Hospital Anxiety and Depression Scale Score;State-trait Anxiety Scale Score;

Secondary

MeasureTime frame
Insomnia Severity Index (ISI);Prospective 7-day Sleep diary;Pediatric Daytime Sleepiness Scale Score;Dysfunctional Beliefs and Attitudes about Sleep Scale-16-item (DBAS-16) ;Acceptance and Action Questionnaire–II (AAQ-II);Pre-Sleep Arousal Scale Score;White Bear Suppression Inventory (WBSI);The Satisfaction With Life Scale Score;

Countries

China

Contacts

Public ContactChan Ngan Yin Rachel

Department of Psychiatry, The Chinese University of Hong Kong

rachel.chan@cuhk.edu.hk+852 3791 0548

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026