Clinical trial NCT06054243: Efficacy of Group Cognitive Behavioural Therapy for Youth Anxiety and Insomnia
Official title: Efficacy of Group Cognitive Behavioural Therapy for Youth Anxiety and Insomnia: A Randomised, Assessor Blind, Parallel-group Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Insomnia
Anxiety
Keywords: Insomnia
Anxiety
Adolescents
Youth
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
Collaborators: name: Chinese University of Hong Kong
name: Goldsmiths, University of London
name: Stanford University
First posted: 2023-09-26
Enrollment: 171
Sex: ALL
Minimum age (years): 12
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Youth is an important transitional stage associated with dynamic changes in biological, cognitive, and psychological functioning, as well as a constellation of developmental and psychosocial challenges. In particular, anxiety disorders constitute the most common mental health problems in youth, with a prevalence rate up to 32%. Youth anxiety is associated with not only profound personal distress, but also considerable impairments in psychosocial functioning and an increased risk for developing other psychiatric comorbidities (e.g. depression, substance use). Meanwhile, sleep problems, particularly insomnia, are also common in the teen years, with a prevalence rate as high as 36%. Insomnia and anxiety are highly comorbid conditions, with increasing evidence suggesting their intricate, bidirectional relationship, such as a high level of anxiety symptoms found in youth with insomnia. However, optimal treatment strategies to manage the comorbidity of these two conditions remain uncertain. This study will test the efficacy of group-based cognitive behavioural therapy for insomnia (CBT-I) and cognitive behavioural therapy for anxiety (CBT-A) in reducing the severity of insomnia and anxiety symptoms in youth with comorbid insomnia and anxiety, as well as their effects on depressive symptoms, daytime functioning (e.g. sleepiness, fatigue), subjective and objective sleep measures.


Eligibility criteria: Inclusion Criteria:

1. Chinese aged 12-20 years old (an age range that was suggested by scholars 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 DSM-5 diagnostic criteria of insomnia disorder and with a score on Insomnia Severity Index (ISI) \>= 9 (suggested cut-off for adolescents); 5) Presenting with a high level of anxiety symptoms as defined by a total score \>32 and \>37 for males and females respectively on Spence Children's Anxiety Scale (SCAS).

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 (other than insomnia) 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 DISP, a validated structured diagnostic interview to assess major sleep disorders according to the 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. Having a clinically significant suicidality (presence of suicidal ideation with a plan or an attempt) as assessed confirmed by research clinician using the MINI Suicidality Module;
7. Currently receiving any structured psychotherapy;
8. With hearing or speech deficit;
9. Night shift worker.

Primary outcomes:
measure: Change of anxiety symptoms (assessor-rated)
timeFrame: Baseline, post-treatment (one-week after completion of the intervention/waiting period) for all participants; and additional two follow-ups at Post-Treatment 1-month and Post-Treatment 6-month for participants in the treatment groups
measure: Change of insomnia symptoms
timeFrame: Baseline, post-treatment (one-week after completion of the intervention/waiting period) for all participants; and additional two follow-ups at Post-Treatment 1-month and Post-Treatment 6-month for participants in the treatment groups
Secondary outcomes:
measure: Change of sleep quality
timeFrame: Baseline, post-treatment (one-week after completion of the intervention/waiting period) for all participants; and additional two follow-ups at Post-Treatment 1-month and Post-Treatment 6-month for participants in the treatment groups
measure: Change of sleep diary measure (time in bed, TIB)
timeFrame: Baseline, post-treatment (one-week after completion of the intervention/waiting period) for all participants; and additional two follow-ups at Post-Treatment 1-month and Post-Treatment 6-month for participants in the treatment groups
measure: Change of sleep diary measure (total sleep time, TST)
timeFrame: Baseline, post-treatment (one-week after completion of the intervention/waiting period) for all participants; and additional two follow-ups at Post-Treatment 1-month and Post-Treatment 6-month for participants in the treatment groups
measure: Change of sleep diary measure (sleep onset latency, SOL)
timeFrame: Baseline, post-treatment (one-week after completion of the intervention/waiting period) for all participants; and additional two follow-ups at Post-Treatment 1-month and Post-Treatment 6-month for participants in the treatment groups
measure: Change of sleep diary measure (wake after sleep onset, WASO)
timeFrame: Baseline, post-treatment (one-week after completion of the intervention/waiting period) for all participants; and additional two follow-ups at Post-Treatment 1-month and Post-Treatment 6-month for participants in the treatment groups
measure: Change of sleep diary measure (sleep efficiency, SE)
timeFrame: Baseline, post-treatment (one-week after completion of the intervention/waiting period) for all participants; and additional two follow-ups at Post-Treatment 1-month and Post-Treatment 6-month for participants in the treatment groups
measure: Change of objective sleep measure (time in bed, TIB)
timeFrame: Baseline, post-treatment (one-week after completion of the intervention/waiting period) for all participants; and additional two follow-ups at Post-Treatment 1-month and Post-Treatment 6-month for participants in the treatment groups
measure: Change of objective sleep measure (total sleep time, TST)
timeFrame: Baseline, post-treatment (one-week after completion of the intervention/waiting period) for all participants; and additional two follow-ups at Post-Treatment 1-month and Post-Treatment 6-month for participants in the treatment groups
measure: Change of objective sleep measure (sleep onset latency, SOL)
timeFrame: Baseline, post-treatment (one-week after completion of the intervention/waiting period) for all participants; and additional two follow-ups at Post-Treatment 1-month and Post-Treatment 6-month for participants in the treatment groups
measure: Change of objective sleep measure (wake after sleep onset, WASO)
timeFrame: Baseline, post-treatment (one-week after completion of the intervention/waiting period) for all participants; and additional two follow-ups at Post-Treatment 1-month and Post-Treatment 6-month for participants in the treatment groups
measure: Change of objective sleep measure (sleep efficiency, SE)
timeFrame: Baseline, post-treatment (one-week after completion of the intervention/waiting period) for all participants; and additional two follow-ups at Post-Treatment 1-month and Post-Treatment 6-month for participants in the treatment groups
measure: Change of dysfunctional beliefs and attitudes about sleep
timeFrame: Baseline, post-treatment (one-week after completion of the intervention/waiting period) for all participants; and additional two follow-ups at Post-Treatment 1-month and Post-Treatment 6-month for participants in the treatment groups
measure: Change of pre-sleep arousal
timeFrame: Baseline, post-treatment (one-week after completion of the intervention/waiting period) for all participants; and additional two follow-ups at Post-Treatment 1-month and Post-Treatment 6-month for participants in the treatment groups
measure: Change of sleep reactivity
timeFrame: Baseline, post-treatment (one-week after completion of the intervention/waiting period) for all participants; and additional two follow-ups at Post-Treatment 1-month and Post-Treatment 6-month for participants in the treatment groups
measure: Change of sleep hygiene and practice
timeFrame: Baseline, post-treatment (one-week after completion of the intervention/waiting period) for all participants; and additional two follow-ups at Post-Treatment 1-month and Post-Treatment 6-month for participants in the treatment groups
measure: Change of daytime sleepiness
timeFrame: Baseline, post-treatment (one-week after completion of the intervention/waiting period) for all participants; and additional two follow-ups at Post-Treatment 1-month and Post-Treatment 6-month for participants in the treatment groups
measure: Change of daytime hyperarousal
timeFrame: Baseline, post-treatment (one-week after completion of the intervention/waiting period) for all participants; and additional two follow-ups at Post-Treatment 1-month and Post-Treatment 6-month for participants in the treatment groups
measure: Change of daytime fatigue
timeFrame: Baseline, post-treatment (one-week after completion of the intervention/waiting period) for all participants; and additional two follow-ups at Post-Treatment 1-month and Post-Treatment 6-month for participants in the treatment groups
measure: Change in sleep timing and chronotype
timeFrame: Baseline, post-treatment (one-week after completion of the intervention/waiting period) for all participants; and additional one follow-up at Post-Treatment 6-month for participants in the treatment groups
measure: Change in chronotype preference
timeFrame: Baseline, post-treatment (one-week after completion of the intervention/waiting period) for all participants; and additional one follow-up at Post-Treatment 6-month for participants in the treatment groups
measure: Change in anxiety symptoms
timeFrame: Baseline, post-treatment (one-week after completion of the intervention/waiting period) for all participants; and additional two follow-ups at Post-Treatment 1-month and Post-Treatment 6-month for participants in the treatment groups
measure: Change of mood symptoms
timeFrame: Baseline, post-treatment (one-week after completion of the intervention/waiting period) for all participants; and additional two follow-ups at Post-Treatment 1-month and Post-Treatment 6-month for participants in the treatment groups
measure: Change of emotional states of depression, anxiety, and stress
timeFrame: Baseline, post-treatment (one-week after completion of the intervention/waiting period) for all participants; and additional two follow-ups at Post-Treatment 1-month and Post-Treatment 6-month for participants in the treatment groups
measure: Change of suicidal ideation
timeFrame: Baseline, post-treatment (one-week after completion of the intervention/waiting period) for all participants; and additional two follow-ups at Post-Treatment 1-month and Post-Treatment 6-month for participants in the treatment groups
measure: Change of state and trait anxiety
timeFrame: Baseline, post-treatment (one-week after completion of the intervention/waiting period) for all participants; and additional two follow-ups at Post-Treatment 1-month and Post-Treatment 6-month for participants in the treatment groups
measure: Change of Locus of Control
timeFrame: Baseline, post-treatment (one-week after completion of the intervention/waiting period) for all participants
measure: Change of Sleep-related Locus of Control
timeFrame: Baseline, post-treatment (one-week after completion of the intervention/waiting period) for all participants
measure: Change of Repetitive Negative Thinking
timeFrame: Baseline, post-treatment (one-week after completion of the intervention/waiting period) for all participants
measure: Change of quality of life
timeFrame: Baseline, post-treatment (one-week after completion of the intervention/waiting period) for all participants; and additional two follow-ups at Post-Treatment 1-month and Post-Treatment 6-month for participants in the treatment groups
measure: Change of overall severity of clinical symptoms
timeFrame: Baseline, post-treatment (one-week after completion of the intervention/waiting period) for all participants; and additional two follow-ups at Post-Treatment 1-month and Post-Treatment 6-month for participants in the treatment groups
measure: Change of objective cognitive performance (attentional bias)
timeFrame: Baseline, post-treatment (one-week after completion of the intervention/waiting period) for all participants; and additional one follow-up at Post-Treatment 6-month for participants in the treatment groups
measure: Change of objective physiological performance (attentional bias)
timeFrame: Baseline, post-treatment (one-week after completion of the intervention/waiting period) for all participants; and additional one follow-up at Post-Treatment 6-month for participants in the treatment groups
measure: Change of objective cognitive performance (working memory)
timeFrame: Baseline, post-treatment (one-week after completion of the intervention/waiting period) for all participants; and additional one follow-up at Post-Treatment 6-month for participants in the treatment groups
measure: Change of objective cognitive performance (working memory)
timeFrame: Baseline, post-treatment (one-week after completion of the intervention/waiting period) for all participants; and additional one follow-up at Post-Treatment 6-month for participants in the treatment groups
measure: Change of objective cognitive performance (inhibitory ability)
timeFrame: Baseline, post-treatment (one-week after completion of the intervention/waiting period) for all participants; and additional one follow-up at Post-Treatment 6-month for participants in the treatment groups
measure: Change of objective cognitive performance (risk-taking & decision making)
timeFrame: Baseline, post-treatment (one-week after completion of the intervention/waiting period) for all participants; and additional one follow-up at Post-Treatment 6-month for participants in the 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: