Effects of Self-help Versus Group Cognitive Behavioural Therapy for Insomnia in Youth

NCT ID: NCT03522701

Last Updated: 2022-05-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-15
• Study Completion Date: 2022-12-01

Brief Summary

Insomnia is the most prevalent sleep problem in both the general and clinical populations. Insomnia symptoms, presented as the problems initiating sleep or maintaining sleep, have 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. Moreover, adolescent insomnia has been found to predict the development of mental health problems in young adulthood.

Currently there is no medication specifically approved for use as hypnotics in children under age 18 by the US Food and Drug Administration (FDA). Although cognitive behavioural therapy for insomnia (CBT-I) has been regarded as the first-line treatment for insomnia in adults, there exists limited evidence for the efficacy of CBT-I among adolescents and young adults. Given the high prevalence and profound consequences of insomnia among youth, further research on the short-term and long-term effects of CBT-I for adolescents is warranted. To address the limitations of the existing literature, this randomised controlled trial aims to examine whether face-to-face (group-based CBT-I) versus self-help insomnia treatment benefit adolescents with insomnia, for improving sleep and other clinical and daytime symptoms as well as overall functional improvement in both the short and long term.

Conditions

Insomnia

Study Design

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

Study Groups

Group CBTI

Behavioral: Cognitive Behavioural Therapy for Insomnia (CBT-I) The intervention will consist of 8 weekly group sessions (90-min, 5-8 adolescents in each group) of CBT-I delivered within a 10-week window. The treatment components in the CBT-I aim to address the behavioural, cognitive and physiological perpetuating factor of insomnia and include: psycho-education about sleep and sleep hygiene, stimulus control, sleep restriction, relaxation training, structured worry time, cognitive restructuring (targeting sleep-related dysfunctional cognitions), and relapse prevention.

Group Type: EXPERIMENTAL

CBTI

Intervention Type: BEHAVIORAL

Refer to the arm description

Email-delivered CBTI

The email delivered self-guided CBT-I consists of 8 weekly learning sessions. Participants will receive an email embedded with session materials each week.

Group Type: ACTIVE_COMPARATOR

CBTI

Intervention Type: BEHAVIORAL

Refer to the arm description

Waiting-list control

Participants will not receive any active treatment.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

CBTI

Refer to the arm description

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. Chinese aged 12-24 years old (according to World Health Organization's defined age range for youth);

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. Being able to comply with the study protocol;

4. Having a diagnosis of insomnia disorder, 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 Diagnostic Interview for Sleep Patterns and Disorders (DISP);

4. Concurrent, regular use of medications(s) known to affect sleep continuity and quality (e.g. hypnotics, steroids);

5. In the opinion of the research clinician, having a clinically significant suicidality (presence of suicidal ideation with a plan or an attempt);

6. Having been enrolled in any other clinical trial investigational products within one month at the entry of the study;

7. Initiation of or change in antidepressant medication within past 2 months;

8. Having been or is currently receiving any structured psychotherapy;

9. With hearing or speech deficit;

10. Night shift worker.

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 24 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chinese University of Hong Kong

OTHER

Sponsor Role: collaborator

The University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Dr. Shirley Xin Li

Assistant 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

Shirley Xin Li, PhD,DClinPsy

Role: primary

shirley.li@hku.hk

852-39177035

Other Identifiers

EA1710023

Identifier Type: -

Identifier Source: org_study_id