Clinical trial NCT03522701: Effects of Self-help Versus Group Cognitive Behavioural Therapy for Insomnia in Youth
Official title: Effects of Self-help Versus Group Cognitive Behavioural Therapy for Insomnia in Youth: a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Insomnia
Keywords: Adolescents
Youth
Insomnia
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
Collaborators: name: Chinese University of Hong Kong
First posted: 2018-05-11
Enrollment: 150
Sex: ALL
Minimum age (years): 12
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomised, assessor-blind, parallel group controlled trial
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Change of insomnia symptoms
timeFrame: 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:
measure: Change of sleep quality
timeFrame: 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
measure: Change of sleep diary measure (time in bed, TIB)
timeFrame: 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]
measure: Change of sleep diary measure (total sleep time, TST)
timeFrame: 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
measure: Change of sleep diary measure (sleep onset latency, SOL)
timeFrame: 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]
measure: Change of sleep diary measure (wake after sleep onset, WASO)
timeFrame: 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
measure: Change of sleep diary measure (sleep efficiency, SE)
timeFrame: 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
measure: Change of objective sleep measure (time in bed, TIB)
timeFrame: Baseline, post-treatment (week 8/at the conclusion of last session) for all participants; and additionally at post-treatment one-month and six-month for those in the two active treatment groups
measure: Change of objective sleep measure (total sleep time, TST)
timeFrame: Baseline, post-treatment (week 8/at the conclusion of last session) for all participants; and additionally at post-treatment one-month and six-month for those in the two active treatment groups
measure: Change of objective sleep measure (sleep onset latency, SOL)
timeFrame: Baseline, post-treatment (week 8/at the conclusion of last session) for all participants; and additionally at post-treatment one-month and six-month for those in the two active treatment groups
measure: Change of objective sleep measure (wake after sleep onset, WASO)
timeFrame: Baseline, post-treatment (week 8/at the conclusion of last session) for all participants; and additionally at post-treatment one-month and six-month for those in the two active treatment groups
measure: Change of daytime sleepiness
timeFrame: 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
measure: Change of daytime fatigue
timeFrame: 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
measure: Change of quality of life
timeFrame: 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
measure: Change of suicidal ideation
timeFrame: 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
measure: Change of self-report mood symptoms
timeFrame: 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
measure: Change of dysfunctional beliefs and attitudes about sleep
timeFrame: 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
measure: Change of sleep hygiene and practice
timeFrame: 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
measure: Change of pre-sleep arousal
timeFrame: 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]
measure: Change of depressive symptoms (assessor-rated)
timeFrame: Baseline, post-treatment (week 8/at the conclusion of last group session) for all participants; and additionally at post-treatment one-month, six-month and 24-month for those in the two active treatment groups
measure: Change of overall severity of clinical symptoms
timeFrame: Baseline, post-treatment (week 8/at the conclusion of last group session) for all participants; and additionally at post-treatment one-month, six-month and 24-month for those in the two active treatment groups
measure: Change of objective cognitive performance (visual attention & task switching)
timeFrame: Baseline, post-treatment (week 8/at the conclusion of last group session) for all participants; and additionally at post-treatment one-month and six-month for those in the two active treatment groups
measure: Change of objective cognitive performance (inhibitory ability)
timeFrame: Baseline, post-treatment (week 8/at the conclusion of last group session) for all participants; and additionally at post-treatment one-month and six-month for those in the two active treatment groups
measure: Change of objective cognitive performance (working memory by digit span)
timeFrame: Baseline, post-treatment (week 8/at the conclusion of last group session) for all participants; and additionally at post-treatment one-month and six-month for those in the two active treatment groups
measure: Change of objective cognitive performance (working memory by N-Back)
timeFrame: Baseline, post-treatment (week 8/at the conclusion of last group session) for all participants; and additionally at post-treatment one-month and six-month for those in the two active treatment groups
measure: Change of objective cognitive performance (episodic memory)
timeFrame: Baseline, post-treatment (week 8/at the conclusion of last group session) for all participants; and additionally at post-treatment one-month and six-month for those in the two active treatment groups
measure: Change of objective cognitive performance (problem solving)
timeFrame: Baseline, post-treatment (week 8/at the conclusion of last group session) for all participants; and additionally at post-treatment one-month and six-month for those in the two active treatment groups
measure: Change of sleep related attention bias
timeFrame: Baseline, post-treatment (week 8/at the conclusion of last group session) for all participants; and additionally at post-treatment one-month and six-month for those in the two active treatment groups
measure: Change of risk-taking & decision making
timeFrame: Baseline, post-treatment (week 8/at the conclusion of last group session) for all participants; and additionally at post-treatment one-month and six-month for those in the two active treatment groups
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Sleep Research Clinic & Laboratory, Department of Psychology, The University of Hong Kong
Study officials:
affiliation: The University of Hong Kong
name: Shirley Xin Li, PhD, DClinPsy
role: PRINCIPAL_INVESTIGATOR
References: