Clinical trial NCT03438331: Effects of Group Cognitive Behavioural Therapy on Comorbid Insomnia and Depression in Youth
Official title: Effects of Group Cognitive Behavioural Therapy on Comorbid Insomnia and Depression in Youth: a Randomised, Assessor Blind, Parallel Group Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insomnia
Depression
Keywords: Insomnia
Depression
Adolescents
Youth
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
Collaborators: name: Chinese University of Hong Kong
name: University of Oxford
First posted: 2018-02-19
Enrollment: 133
Sex: ALL
Minimum age (years): 12
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Major depressive disorder (MDD) is among the most common psychiatric disorders among adolescents, and is associated with considerable psychosocial and functional impairments and an elevated risk of suicidal behaviour and completed suicide. Meanwhile, sleep disturbance, particularly insomnia, is among the most prevalent and prominent presenting complaints in adolescents with depression. Despite its high prevalence, insomnia often remains overlooked and under-treated in clinical practice. However, growing evidence suggests an intricate relationship between insomnia and depression, which has become an area in need of further focused attention. This project will involve a randomised controlled trial proposed to examine whether insomnia treatment confers additional benefit to depression treatment in adolescents with comorbid depression and insomnia, for improving sleep and depressive symptoms, and other clinical and daytime symptoms as well as overall functional improvement in both the short and long term. Eligible adolescent participants will be randomised to either intervention (8-week group Cognitive Behavioural Therapy for Insomnia, CBT-I, or 8-week group Cognitive Behavioural Therapy for Depression, CBT-D) or waiting-list control condition. Assessments will be conducted at pre-treatment (week 0), during the treatment (week 2, 4, 6) and post-treatment (week 8/at the conclusion of the last group session). The two active treatment groups will be additionally followed up at posttreatment one-month and six-month.


Eligibility criteria: Inclusion Criteria:

1. Chinese aged 12-24 years old;
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 DSM-V diagnosis of insomnia disorder, with a score on Insomnia Severity Index (ISI) \>=9; AND a DSM-V diagnosis of depressive disorder

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 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 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 self-report mood 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 insomnia 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
Secondary outcomes:
measure: Change of sleep quality
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 sleep diary measure (time in bed, TIB)
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 sleep diary measure (total sleep time, TST)
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 sleep diary measure (sleep onset latency, SOL)
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 sleep diary measure (wake after sleep onset, WASO)
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 sleep diary measure (sleep efficiency, SE)
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 sleep measure (time in bed, TIB)
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 sleep measure (total sleep time, TST)
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 sleep measure (sleep onset latency, SOL)
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 sleep measure (wake after sleep onset, WASO)
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 sleep measure (sleep efficiency, SE)
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 daytime sleepiness
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 daytime fatigue
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 quality of life
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 suicidal ideation
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 subjective cognitive performance
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 (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
measure: Change of dysfunctional beliefs and attitudes about sleep
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 sleep hygiene and practice
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 pre-sleep arousal
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
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: