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

The University of Hong Kong (HKU)

Status: Completed

Conditions: Insomnia

Treatments: Behavioral: group CBTI; Behavioral: digital CBTI

Study type: Interventional

Funder types: Other

Identifiers

NCT05270369

EA200037

Details and patient eligibility

About

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.

Enrollment: 159 patients

Sex: All

Ages: 12 to 20 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• (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)

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 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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159 participants in 3 patient groups

digital cognitive behavioural therapy for insomnia (CBTI)

Experimental group

Description:

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

Treatment:

Behavioral: digital CBTI

group cognitive behavioural therapy for insomnia (CBTI)

Experimental group

Description:

The group CBTI will receive 6-session CBTI in group

Treatment:

Behavioral: group CBTI

waitlist

No Intervention group

Description:

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