Back to resultsComparison of the Effects of Support and Non-support Online CBT-I
Primary Purpose
Insomnia
Status
Recruiting
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Cognitive behavioral therapy
Sponsored by
About this trial
This is an interventional treatment trial for Insomnia
Eligibility Criteria
Inclusion Criteria:
- Chinese aged 12-24 years old;
- 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 DSM-5 diagnosis of insomnia disorder, with a score on Insomnia Severity Index (ISI) >= 9 (suggested cut-off for adolescents)
Exclusion Criteria:
- 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;
- 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.
Sites / Locations
- Sleep Research Clinic & Laboratory, Department of Psychology, The University of Hong KongRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
online CBT-I with support (individualized feedback and reminders)
online CBT-I without support
Arm Description
The mobile-APP based CBT-I consists of 6 weekly session. The treatment is structured and based on the well-established CBT elements for treating insomnia. 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. reminders and individualized feedback regarding the behavioral strategies will be sent to the participant every week.
same as the experimental arm but without reminders and individualized feedback
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Change of sleep quality
Pittsburgh Sleep Quality Index (PSQI) is a self-rated scale consisting of 19 questions. All items are combined to form seven component scores on different aspects of sleep quality, each of which ranges from 0 to 3 points with higher scores representing more sleep disturbance. The seven component scores are added to one global score, which ranges from 0 to 21, with higher scores indicating more difficulties with sleep.
Change of sleep diary measure (total time in bed)
Daily sleep diary for consecutive seven days. Sleep parameter estimated by daily sleep diary: total time in bed (minutes)
Change of sleep diary measure (total sleep time)
Daily sleep diary for consecutive seven days. Sleep parameter estimated by daily sleep diary: total sleep time (minutes)
Change of sleep diary measure (sleep efficiency)
Daily sleep diary for consecutive seven days. Sleep parameter estimated by daily sleep diary: sleep efficiency (%)
Change of sleep diary measure (sleep onset latency)
Daily sleep diary for consecutive seven days. Sleep parameter estimated by daily sleep diary: sleep onset latency (minutes)
Change of sleep diary measure (wake after sleep onset)
Daily sleep diary for consecutive seven days. Sleep parameter estimated by daily sleep diary: wake after sleep onset (minutes).
Change of daytime sleepiness
Paediatric Daytime Sleepiness Scale (PDSS) is an 8-item self-rated scale measuring daytime sleepiness, ranging in total scores from 0 to 32 with higher scores indicating more sleepiness.
Change of daytime fatigue
Multidimensional Fatigue Inventory (MFI) is a 20-item self-rated scale on fatigue symptoms. There are three subscales, measuring the physical (possibly scored from 7 to 35), mental (possibly scored from 6 to 30), and spiritual (possibly scored from 7 to 35), dimensions of fatigue. A grand total score can be calculated by summing up the three sub scores. In all cases, a higher score represents higher fatigue symptoms.
Change of quality of life
KIDSCREEN-27 is a 27-item self-rated scale measuring health related quality of life measure for children and adolescents. There are five subscales on: physical well-being (possibly scored from 5 to 25), psychological well-being (possibly scored 7 to 35), autonomy & parents (possibly scored 7 to 35), peers & social support (possibly scored 4 to 20), and school environment (possibly scored 4 to 20). A grand total score can be calculated by summing up the five sub scores. In all cases, a higher score represents higher perceived well-being.
Change of suicidal ideation
Depressive Symptom Inventory Suicidality Subscale (DSI-SS) is a 4-item self-rated scale measuring suicidal ideation. Possible total scores range from 0 to 12, with higher scores indicating higher suicidal ideation.
Change of self-report mood symptoms
Hospital Anxiety and Depression Scale (HADS) is a self-assessed scale for detecting states of depression and anxiety. The depression subscale range in scores from 0 to 21, with higher scores indicating severer states of depression. Similarly, the anxiety subscale range in scores from 0-21 with higher scores indicating severer states of anxiety. No additional computation will be made with the two subscores
Change of dysfunctional beliefs and attitudes about sleep
Dysfunctional Beliefs and Attitudes about Sleep (DBAS) is a 16-item self-rated scale measuring the respondent's sleep-related beliefs, more specifically, their expectations and attitudes regarding the causes, consequences, and potential treatments of sleep issues. A total score is calculated by averaging score of all items, possibly scored 0 to 10, with a higher score indicating more dysfunctional beliefs and attitudes about sleep.
Change of sleep hygiene and practice
Sleep Hygiene Practice Scale (SHPS) is a 30-item self-rated scale measuring sleep hygiene behaviors, ranging in total scores from 30 to 180, with higher scores indicating lower levels of sleep hygiene.
Change of pre-sleep arousal
Pre-Sleep Arousal Scale is a 16-item self-rated scale measuring pre-sleep arousal. There are two subscales on the cognitive and somatic manifestations of arousal, with eight items in each subscale (possibly scored from 8 to 40). In both cases, a higher score indicates higher pre-sleep arousal.
Full Information
NCT ID
NCT05011929
First Posted
April 24, 2021
Last Updated
February 14, 2022
Sponsor
The University of Hong Kong
Collaborators
Chinese University of Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT05011929
Brief Title
Comparison of the Effects of Support and Non-support Online CBT-I
Official Title
Comparison of the Effects of Support and Non-support Online Cognitive Behavioural Therapy for Insomnia in Youth: a Randomised Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 10, 2019 (Actual)
Primary Completion Date
December 1, 2022 (Anticipated)
Study Completion Date
December 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Hong Kong
Collaborators
Chinese University of Hong Kong
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Insomnia is the most prevalent sleep problem in children and adolescents and it has been found to predict the development of mental health problems in young adulthood. Cognitive behavioral therapy for insomnia (CBT-I) has been found to be effective in both adults and adolescents. However, limited accessibility and availability of the treatment has only benefited a small proportion of insomnia patients. Therefore, digital CBT-I has been promoted as an alternative way to manage individual's insomnia problems with adequate efficacy. Nonetheless, one of the major limitations of the online self-help intervention is the relatively high drop-out rate and lower compliance compared to the face-to-face modality which the interactive component is less practical in the online intervention. Therefore, the objectives of current study are 1) evaluate the efficacy of mobile-APP based CBT-I in treating youth insomnia, 2) evaluate whether the provision of additional support could further enhance the treatment outcomes.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A randomised, assessor-blind, parallel group controlled trial
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
online CBT-I with support (individualized feedback and reminders)
Arm Type
Experimental
Arm Description
The mobile-APP based CBT-I consists of 6 weekly session. The treatment is structured and based on the well-established CBT elements for treating insomnia. 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. reminders and individualized feedback regarding the behavioral strategies will be sent to the participant every week.
Arm Title
online CBT-I without support
Arm Type
Active Comparator
Arm Description
same as the experimental arm but without reminders and individualized feedback
Intervention Type
Behavioral
Intervention Name(s)
Cognitive behavioral therapy
Intervention Description
refer to the arm description
Primary Outcome Measure Information:
Title
Change of insomnia symptoms
Description
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.
Time Frame
Baseline, post-treatment (week 6/at the conclusion of last session) for all participants; and additionally at post-treatment one-month and six-months for those in the two active treatment groups
Secondary Outcome Measure Information:
Title
Change of sleep quality
Description
Pittsburgh Sleep Quality Index (PSQI) is a self-rated scale consisting of 19 questions. All items are combined to form seven component scores on different aspects of sleep quality, each of which ranges from 0 to 3 points with higher scores representing more sleep disturbance. The seven component scores are added to one global score, which ranges from 0 to 21, with higher scores indicating more difficulties with sleep.
Time Frame
Baseline, post-treatment (week 6/at the conclusion of last session) for all participants; and additionally at post-treatment one-month and six-months for those in the two active treatment groups
Title
Change of sleep diary measure (total time in bed)
Description
Daily sleep diary for consecutive seven days. Sleep parameter estimated by daily sleep diary: total time in bed (minutes)
Time Frame
Baseline, post-treatment (week 6/at the conclusion of last session) for all participants; and additionally at post-treatment one-month and six-months for those in the two active treatment groups
Title
Change of sleep diary measure (total sleep time)
Description
Daily sleep diary for consecutive seven days. Sleep parameter estimated by daily sleep diary: total sleep time (minutes)
Time Frame
Baseline, post-treatment (week 6/at the conclusion of last session) for all participants; and additionally at post-treatment one-month and six-months for those in the two active treatment groups
Title
Change of sleep diary measure (sleep efficiency)
Description
Daily sleep diary for consecutive seven days. Sleep parameter estimated by daily sleep diary: sleep efficiency (%)
Time Frame
Baseline, post-treatment (week 6/at the conclusion of last session) for all participants; and additionally at post-treatment one-month and six-months for those in the two active treatment groups
Title
Change of sleep diary measure (sleep onset latency)
Description
Daily sleep diary for consecutive seven days. Sleep parameter estimated by daily sleep diary: sleep onset latency (minutes)
Time Frame
Baseline, post-treatment (week 6/at the conclusion of last session) for all participants; and additionally at post-treatment one-month and six-months for those in the two active treatment groups
Title
Change of sleep diary measure (wake after sleep onset)
Description
Daily sleep diary for consecutive seven days. Sleep parameter estimated by daily sleep diary: wake after sleep onset (minutes).
Time Frame
Baseline, post-treatment (week 6/at the conclusion of last session) for all participants; and additionally at post-treatment one-month and six-months for those in the two active treatment groups
Title
Change of daytime sleepiness
Description
Paediatric Daytime Sleepiness Scale (PDSS) is an 8-item self-rated scale measuring daytime sleepiness, ranging in total scores from 0 to 32 with higher scores indicating more sleepiness.
Time Frame
Baseline, post-treatment (week 6/at the conclusion of last session) for all participants; and additionally at post-treatment one-month and six-months for those in the two active treatment groups
Title
Change of daytime fatigue
Description
Multidimensional Fatigue Inventory (MFI) is a 20-item self-rated scale on fatigue symptoms. There are three subscales, measuring the physical (possibly scored from 7 to 35), mental (possibly scored from 6 to 30), and spiritual (possibly scored from 7 to 35), dimensions of fatigue. A grand total score can be calculated by summing up the three sub scores. In all cases, a higher score represents higher fatigue symptoms.
Time Frame
Baseline, post-treatment (week 6/at the conclusion of last session) for all participants; and additionally at post-treatment one-month and six-months for those in the two active treatment groups
Title
Change of quality of life
Description
KIDSCREEN-27 is a 27-item self-rated scale measuring health related quality of life measure for children and adolescents. There are five subscales on: physical well-being (possibly scored from 5 to 25), psychological well-being (possibly scored 7 to 35), autonomy & parents (possibly scored 7 to 35), peers & social support (possibly scored 4 to 20), and school environment (possibly scored 4 to 20). A grand total score can be calculated by summing up the five sub scores. In all cases, a higher score represents higher perceived well-being.
Time Frame
Baseline, post-treatment (week 6/at the conclusion of last session) for all participants; and additionally at post-treatment one-month and six-months for those in the two active treatment groups
Title
Change of suicidal ideation
Description
Depressive Symptom Inventory Suicidality Subscale (DSI-SS) is a 4-item self-rated scale measuring suicidal ideation. Possible total scores range from 0 to 12, with higher scores indicating higher suicidal ideation.
Time Frame
Baseline, post-treatment (week 6/at the conclusion of last session) for all participants; and additionally at post-treatment one-month and six-months for those in the two active treatment groups
Title
Change of self-report mood symptoms
Description
Hospital Anxiety and Depression Scale (HADS) is a self-assessed scale for detecting states of depression and anxiety. The depression subscale range in scores from 0 to 21, with higher scores indicating severer states of depression. Similarly, the anxiety subscale range in scores from 0-21 with higher scores indicating severer states of anxiety. No additional computation will be made with the two subscores
Time Frame
Baseline, post-treatment (week 6/at the conclusion of last session) for all participants; and additionally at post-treatment one-month and six-months for those in the two active treatment groups
Title
Change of dysfunctional beliefs and attitudes about sleep
Description
Dysfunctional Beliefs and Attitudes about Sleep (DBAS) is a 16-item self-rated scale measuring the respondent's sleep-related beliefs, more specifically, their expectations and attitudes regarding the causes, consequences, and potential treatments of sleep issues. A total score is calculated by averaging score of all items, possibly scored 0 to 10, with a higher score indicating more dysfunctional beliefs and attitudes about sleep.
Time Frame
Baseline, post-treatment (week 6/at the conclusion of last session) for all participants; and additionally at post-treatment one-month and six-months for those in the two active treatment groups
Title
Change of sleep hygiene and practice
Description
Sleep Hygiene Practice Scale (SHPS) is a 30-item self-rated scale measuring sleep hygiene behaviors, ranging in total scores from 30 to 180, with higher scores indicating lower levels of sleep hygiene.
Time Frame
Baseline, post-treatment (week 6/at the conclusion of last session) for all participants; and additionally at post-treatment one-month and six-months for those in the two active treatment groups
Title
Change of pre-sleep arousal
Description
Pre-Sleep Arousal Scale is a 16-item self-rated scale measuring pre-sleep arousal. There are two subscales on the cognitive and somatic manifestations of arousal, with eight items in each subscale (possibly scored from 8 to 40). In both cases, a higher score indicates higher pre-sleep arousal.
Time Frame
Baseline, post-treatment (week 6/at the conclusion of last session) for all participants; and additionally at post-treatment one-month and six-months for those in the two active treatment groups
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
24 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Chinese aged 12-24 years old;
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 DSM-5 diagnosis of insomnia disorder, with a score on Insomnia Severity Index (ISI) >= 9 (suggested cut-off for adolescents)
Exclusion Criteria:
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;
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shirley Xin Li, PhD
Phone
852 39177035
Email
shirley.li@hku.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shirley Xin Li, PhD
Organizational Affiliation
The University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sleep Research Clinic & Laboratory, Department of Psychology, The University of Hong Kong
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shirley Xin Li, PhD, DClinPsy
Phone
+852 3917-7035
Email
shirley.li@hku.hk
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Comparison of the Effects of Support and Non-support Online CBT-I
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