CBT-I Versus CBT-I+ACT for Youths With Insomnia and Anxiety

Anxiety Clinical Trial

Official title:

Effectiveness of CBT-I and CBT-I Combined ACT for Insomnia and Anxiety Symptoms in Youth: A Randomised Control Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06156306
• Other study ID #: 20230914
• Status: Recruiting
• Phase: N/A
• Start date: December 15, 2023
• Est. completion date: March 31, 2025

Study information

• Verified date: April 2024
• Source: Chinese University of Hong Kong
• Contact: Rachel Ngan Yin Chan, PhD
• Phone: 39710550
• Email: rachel.chan[@]cuhk.edu.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Insomnia in adolescents and youth is a long-standing public health concern due to its high prevalence and association with various physical and mental health problems. Insomnia and psychiatric disorders are highly comorbid and intercorrelated in adolescents. Among all mental disorders, anxiety has been shown to be have high comorbidity with insomnia, affecting approximately 30% of individuals. CBT for insomnia (CBT-I) has been shown to be effective in improving sleep complaints and short-term improvement in mood while previous systematic reviews of interventional studies have demonstrated the effectiveness of acceptance and commitment therapy (ACT) interventions in treating insomnia, both as a primary condition and with other physical and/or mental health comorbidities. This study aims to compare the effect of CBT-I and CBT-I combined ACT in improving anxiety symptoms in youth.

Description:

Insomnia and psychiatric disorders are highly comorbid and intercorrelated in adolescents. Among all mental disorders, anxiety has been shown to be have high comorbidity with insomnia, affecting approximately 30% of individuals. Moreover, approximately three-quarters of anxious youth also report sleep-related problems. Literature reviews have investigated the relationship and the shared underlying mechanisms between sleep and anxiety. Anxiety sensitivity and pre-sleep arousal have been found to play a critical role in difficulty initiating sleep, which is the most common insomnia symptoms in adolescent population, partially due their natural delay of circadian rhythm. The findings suggest shared neurological and cognitive features that may account for dysregulation of both sleep and affect. Management targeting both sleep and anxiety is recommended due to potentially higher treatment efficacy and cost-effectiveness.

Accumulating evidence supports the effectiveness of cognitive-behavioural therapy for insomnia (CBT-I) and acceptance and commitment therapy (ACT) for addressing sleep and mood problems in adolescents. However, Only a few studies have directly compared the effectiveness of CBT-I and ACT. Past studies have shown that both CBT-I and ACT were effective in treating insomnia in adults.

This current study aims to compare the effect of CBT-I and CBT-I combined ACT in improving anxiety symptoms in youth. The primary hypothesis is that subjects in CBT-I combined ACT will have fewer anxiety symptoms as compared to CBT-I at post-intervention and 3-month follow-up.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: March 31, 2025
• Est. primary completion date: December 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 24 Years

Eligibility

Inclusion Criteria:

Youth who meet the following criteria would be eligible for taking part in this trial:

i. Chinese youth aged 15-24 years old, ii. Presence of insomnia problems as defined by insomnia severity index (ISI) using cut-off of 9, which has been locally validated cut off for detecting clinical insomnia), iii. Presence of anxiety features as defined by General Anxiety Disorder-7 (GAD-7) using cut-off of 10 for detecting clinical anxiety, iv. Ability to listen, speak, and read Chinese and Cantonese, and v. Written informed consent of participation into the study is given by youth and his/her parent's if under 18 years old; In addition, individual assent will also be obtained for subjects under age 18 years old vi. Possession of smartphone

Exclusion Criteria:

A youth would be excluded from the study if meeting one or more of the following criteria:

i. A clinical diagnosis of psychosis, schizophrenia, bipolar disorders, or intellectual disability ii. Having a diagnosed sleep disorder (e.g. delayed sleep phase and narcolepsy) that may potentially contribute to the disruption of sleep quantity and quality as determined by validated Diagnostic Interview for Sleep Patterns and Disorders (DISP) iii. Having a clinically significant suicidality (presence of suicidal ideation with a plan or an attempt) as assessed by The Structured Clinical Interview (SCID) iv. Currently receiving psychological treatment and/or pharmacological treatment for insomnia or anxiety disorder.

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Insomnia
• Sleep Initiation and Maintenance Disorders
• Youth

Intervention

Behavioral:
• CBT-I
The CBT-I intervention will cover sleep education, stimulus control, sleep restriction, cognitive therapy and relaxation training.
• CBT-I combined ACT
In addition to the standard CBT-I components, mindfulness, thought diary, and other ACT components will be taught in the group.

Locations

Country	Name	City	State
Hong Kong	Department of Psychiatry, the Chinese University of Hong Kong	Sha Tin	New Territories

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Severity of anxiety symptoms and severity	General Anxiety Disorder-7 (GAD-7) will be used to assess anxiety symptoms and severity.	Baseline, Postintervention (6 weeks), and 3-month follow up
Primary	Severity of anxiety symptoms	Hospital Anxiety and Depression Scale (HADS) will be used to assess anxiety symptoms.	Baseline, Postintervention (6 weeks), and 3-month follow up
Primary	Clinician-rated severity of anxiety symptoms	Hamilton Anxiety Rating Scale (HAM-A) will be used to assess anxiety symptoms.	Baseline, Postintervention (6 weeks), and 3-month follow up
Secondary	Severity of insomnia symptoms	Insomnia Severity Index (ISI) will be used to measure the severity of insomnia symptoms.	Baseline, Postintervention (6 weeks), and 3-month follow up
Secondary	Sleep-wake pattern	Youths will be asked to keep a sleep diary to chart their daily sleep-wake pattern including sleep duration, wakeup time, bedtime and sleep latency	Baseline, Postintervention (6 weeks), and 3-month follow up
Secondary	Daytime sleepiness	Pediatric Daytime Sleepiness Scale (PDSS) will be used to assess adolescents' daytime sleepiness.	Baseline, Postintervention (6 weeks), and 3-month follow up
Secondary	Anxiety trait	The State-Trait Anxiety Inventory (STAI) will be used to measure anxiety trait	Baseline, Postintervention (6 weeks), and 3-month follow up
Secondary	Severity of depressive symptoms	Patient Health Questionnaire 9-item (PHQ-9) will be used to measure the severity of depressive symptoms.	Baseline, Postintervention (6 weeks), and 3-month follow up
Secondary	Faulty sleep-related beliefs and cognitions	Dysfunctional Beliefs and Attitudes about Sleep Scale-16-item (DBAS-16) will be used to measure faulty sleep-related beliefs and cognitions, which are cognitive aspects typically involved in the maintenance of insomnia.	Baseline, Postintervention (6 weeks), and 3-month follow up
Secondary	Frequency of an individual practice sleep hygiene	Sleep Hygiene Practice Scale (SHPS) will be used to measure the frequency of an individual practice sleep hygiene.	Baseline, Postintervention (6 weeks), and 3-month follow up
Secondary	Psychological flexibility and experiential avoidance	Acceptance and Action Questionnaire-II (AAQ-II) is related to the underlying ACT theory to measure psychological flexibility and experiential avoidance.	Baseline, Postintervention (6 weeks), and 3-month follow up
Secondary	Individual's state of arousal	Pre-Sleep Arousal Scale (PSAS) will be used to measure individual's state of arousal as one falls asleep.	Baseline, Postintervention (6 weeks), and 3-month follow up
Secondary	Tendency to ruminate	The Ruminative Responses Scale - short version (RRS-10) is a 10-item scale on a 4-likert scale. It measures the tendency to ruminate.	Baseline, Postintervention (6 weeks), and 3-month follow up
Secondary	Major life events and hassles	The Adolescent Stress Index (ASI), which was developed using a Hong Kong student sample, will be used to measure major life events and hassles	Baseline, Postintervention (6 weeks), and 3-month follow up
Secondary	Global cognitive appraisal of one's life satisfaction	The Satisfaction With Life Scale (SWLS): SWLS is a 5-item scale on a 7-Likert scale. It measures the global cognitive appraisal of one's life satisfaction.	Baseline, Postintervention (6 weeks), and 3-month follow up
Secondary	Subjective well-being in the previous week	The International Positive and Negative Affect Schedule Short Form (IPANAS-SF) will be used to capture the subjective well-being in the previous week. It has 9 items on a 5-Likert scale with previous study demonstrating satisfactory internal consistency reliability and reasonable nomological validity in Chinese youth.	Baseline, Postintervention (6 weeks), and 3-month follow up