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

NCT03522701 | Unknown

• 1 other identifier: EA1710023
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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

Keywords

Adolescents; Youth; Insomnia

Outcome Measures

Primary Outcomes (1)

• Change of insomnia symptoms

  Insomnia Severity Index (ISI) is a 5-item self-rated scale. Possible scores range from 0 to 20, with higher scores indicating higher insomnia severity.

  Baseline, post-treatment (week 8/at the conclusion of last session) for all participants; and additionally at post-treatment one-month, six-month and 24-month for those in the two active treatment groups

Secondary Outcomes (28)

• Change of sleep quality

  Baseline, post-treatment (week 8/at the conclusion of last session) for all participants; and additionally at post-treatment one-month, six-month and 24-month for those in the two active treatment groups

• Change of sleep diary measure (time in bed, TIB)

  Baseline, post-treatment (week 8/at the conclusion of last session) for all participants; and additionally at post-treatment one-month, six-month and 24-month for those in the two active treatment groups]

• Change of sleep diary measure (total sleep time, TST)

  Baseline, post-treatment (week 8/at the conclusion of last session) for all participants; and additionally at post-treatment one-month, six-month and 24-month for those in the two active treatment groups

• Change of sleep diary measure (sleep onset latency, SOL)

  Baseline, post-treatment (week 8/at the conclusion of last session) for all participants; and additionally at post-treatment one-month, six-month and 24-month for those in the two active treatment groups]

• Change of sleep diary measure (wake after sleep onset, WASO)

  Baseline, post-treatment (week 8/at the conclusion of last session) for all participants; and additionally at post-treatment one-month, six-month and 24-month for those in the two active treatment groups

Study Arms (3)

Group CBTI

EXPERIMENTAL

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.

Behavioral: CBTI

Email-delivered CBTI

ACTIVE COMPARATOR

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

Behavioral: CBTI

Waiting-list control

NO INTERVENTION

Participants will not receive any active treatment.

Interventions

CBTI BEHAVIORAL

Refer to the arm description

Email-delivered CBTI; Group CBTI

Eligibility Criteria

• Age: 12 Years - 24 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Chinese aged 12-24 years old (according to World Health Organization's defined age range for youth);
• Written informed consent of participation into the study is given by the participant and his/her parent or guardian (for those aged under 18);
• Being able to comply with the study protocol;
• Having a diagnosis of insomnia disorder, with a score on Insomnia Severity Index (ISI) \>= 9 (suggested cut-off for adolescents)

You may not qualify if:

• 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;
• Having a prominent medical condition known to interfere with sleep continuity and quality (e.g. eczema, gastro-oesophageal reflux disease);
• 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);
• Concurrent, regular use of medications(s) known to affect sleep continuity and quality (e.g. hypnotics, steroids);
• In the opinion of the research clinician, having a clinically significant suicidality (presence of suicidal ideation with a plan or an attempt);
• Having been enrolled in any other clinical trial investigational products within one month at the entry of the study;
• Initiation of or change in antidepressant medication within past 2 months;
• Having been or is currently receiving any structured psychotherapy;
• With hearing or speech deficit;
• Night shift worker.

Sponsors & Collaborators

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

Study Sites (1)

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

Hong Kong, Hong Kong

RECRUITING

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

Central Study Contacts

Shirley Xin Li, PhD, DClinPsy

CONTACT

(852)39177035; shirley.li@hku.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: A randomised, assessor-blind, parallel group controlled trial

Study Record Dates

• First Submitted: May 1, 2018
• First Posted: May 11, 2018
• Study Start: May 15, 2017
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: May 24, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)