Back to resultsLow-intensity Cognitive-behavioural Therapy for Insomnia
Primary Purpose
Insomnia
Status
Completed
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Cognitive behavioural therapy for insomnia
Sleep hygiene education
Sponsored by
About this trial
This is an interventional treatment trial for Insomnia focused on measuring Insomnia, Cognitive behavioural therapy for insomnia, Sleep hygiene education
Eligibility Criteria
Inclusion Criteria:
- Hong Kong residents
- Aged 16 or above
- Satisfy the DSM-5 criteria for insomnia, i.e. inability to fall or keep asleep, or wake up too early for 3 days or more per week, throughout a minimum period of 1 month (instead of 3 months in the diagnostic criteria D) using the Brief Insomnia Questionnaire. This is to include episodic insomnia which is considered as an 'other specified insomnia disorder' in DSM-5.
- Score at least 10 points in Insomnia Severity Index
- Able to read and understand Cantonese
- Have Internet access
Exclusion Criteria:
- Suffer from recently diagnosed and untreated medical, psychiatric or sleep disorders that likely contribute to the onset and maintenance of insomnia, e.g. major depressive disorder, obstructive sleep apnea, restless legs syndrome, chronic pain.
- Currently receiving CBTI or SHE
- Work on irregular rotational shift
Sites / Locations
- The University of Hong Kong
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
CBTI Workshop
Self-Help CBTI
SHE Workshop
Arm Description
The first intervention group (Group 1) will attend one half-day CBTI workshop in the community setting. The workshop is subdivided into 4 sessions, covering topics regarding regulation of stimuli, limit of sleeping duration, relaxation, sleep hygiene and alteration of cognitive beliefs (Arnedt, Cuddihy, & Swanson, et al, 2014; Morin, Savard, Ouellet, & Daley, 2003). One workshop has the capacity of 30 participants.
The second intervention group (Group 2) will receive self-help CBTI. A CBTI webpage will be set up and the subjects are asked to review all the materials in it. The content is the same as that in Group 1.
The control group (Group 3) will receive SHE. To ensure uniformity of the therapy model, the participants will also need to attend one half-day face-to-face session, covering topics related to sleep hygiene only. The capacity is also 30 participants.
Outcomes
Primary Outcome Measures
Change in Insomnia severity
To identify whether CBTI workshop, self-help CBTI or SHE workshop results in the greatest alleviation of insomnia severity using the Insomnia Severity Index, which allows the patients to rate their perceived severity and satisfaction level towards their current conditions (Arnedt, Cuddihy & Swanson, et al, 2014; Wong, Zhang & Li, et al, 2017).
Secondary Outcome Measures
Change in Symptoms of Mood disorders
To identify which of the 3 therapies brings the largest reduction mood disorders through the Hospital Anxiety and Depression Scale.
Change in Quality of life
To investigate which of the 3 therapies improves the quality of life of patients to the greatest extent using the Short-Form Six-Dimension Health Survey.
Full Information
NCT ID
NCT03736694
First Posted
November 7, 2018
Last Updated
March 23, 2020
Sponsor
The University of Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT03736694
Brief Title
Low-intensity Cognitive-behavioural Therapy for Insomnia
Official Title
A Randomized Controlled Trial to Compare the Effects of Cognitive Behavioral Therapy Workshop, Sleep Hygiene Education Workshop and Self-Help Cognitive Behavioral Therapy on Adults With Sleep Impairment in Hong Kong
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
September 1, 2018 (Actual)
Primary Completion Date
June 30, 2019 (Actual)
Study Completion Date
July 31, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Hong Kong
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
A randomized controlled trial is proposed to compare the effectiveness of workshop-based and self-Help cognitive behavioral therapy for insomnia (CBTI), and sleep hygiene education (SHE) to treat insomnia in Hong Kong adolescent and adult patients, in terms of alleviation of insomnia severity, reduction in associated insomnia symptoms/ complications, and enhancement in quality of life. Insomnia is prevalent in Hong Kong and can cause severe impacts on patients and society, but there is a dearth of related research in the local population. Therefore, it is significant to conduct this study. A total of 210 participants aged > 18 with insomnia will be recruited and randomized into 3 groups to receive one of the 3 treatments. Outcomes will be measured using relevant questionnaires filled in at the baseline, 6 and 12 weeks afterwards. The results obtained will be compared within each group and among the 3 groups using statistical testing to determine the most effective treatment option for insomnia.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia
Keywords
Insomnia, Cognitive behavioural therapy for insomnia, Sleep hygiene education
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A prospective randomized controlled trial (RCT) will be performed to compare the effectiveness of the 3 types of therapies.
After recruitment and assessment for inclusion and exclusion criteria, the participants are randomly assigned with numbers generated by computer and divided equally into 3 groups managed by an independent administrator.
The first intervention group (Group 1) will attend one half-day cognitive behavioural therapy for insomnia (CBTI) workshop in the community setting. The second intervention group (Group 2) will receive self-help CBTI. The control group (Group 3) will receive sleep hygiene education (SHE).
Masking
InvestigatorOutcomes Assessor
Masking Description
After recruitment and assessment for inclusion and exclusion criteria, the participants are randomly assigned with numbers generated by computer and divided equally into 3 groups managed by an independent administrator.
The participants are required to fill in online questionnaires themselves to prevent possible biases during outcome assessments.
The participants will be labelled by numbers without any personal information or intervention group allocated during data analysis.
Allocation
Randomized
Enrollment
210 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CBTI Workshop
Arm Type
Experimental
Arm Description
The first intervention group (Group 1) will attend one half-day CBTI workshop in the community setting. The workshop is subdivided into 4 sessions, covering topics regarding regulation of stimuli, limit of sleeping duration, relaxation, sleep hygiene and alteration of cognitive beliefs (Arnedt, Cuddihy, & Swanson, et al, 2014; Morin, Savard, Ouellet, & Daley, 2003). One workshop has the capacity of 30 participants.
Arm Title
Self-Help CBTI
Arm Type
Experimental
Arm Description
The second intervention group (Group 2) will receive self-help CBTI. A CBTI webpage will be set up and the subjects are asked to review all the materials in it. The content is the same as that in Group 1.
Arm Title
SHE Workshop
Arm Type
Active Comparator
Arm Description
The control group (Group 3) will receive SHE. To ensure uniformity of the therapy model, the participants will also need to attend one half-day face-to-face session, covering topics related to sleep hygiene only. The capacity is also 30 participants.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive behavioural therapy for insomnia
Intervention Description
CBTI involves habitual, belief and attitude alterations so as to eliminate factors preventing sleep (Morin, Savard, Ouellet, & Daley, 2003). It is recommended by the American College of Physicians as the first-line therapy for insomnia (Qaseem, Kansagara, Forciea, Cooke, & Denberg, 2016). CBTI workshops are a relatively novel and emerging way of delivery which involves a greater number of patients than group CBTI, increases availability and accessibility by concentrating the content into half or whole day and taking place in the community settings, and reduces diagnostic labeling and cost (Bonin, Beecham, Swift, Raikundalia, & Brown, 2014; Swift, Stewart, Andiappan, Smith, Espie, & Brown, 2012). Self-help CBTI involves independent learning of the provided materials via the Internet, video or audio recording, books and pamphlets (Bruin, Bogels, Oort, & Meijer, 2015).
Intervention Type
Behavioral
Intervention Name(s)
Sleep hygiene education
Intervention Description
SHE, is commonly provided verbally or through leaflets during consultations (Espie, 2009), and is also included as a part of CBTI (Morin, Savard, Ouellet, & Daley, 2003).
Primary Outcome Measure Information:
Title
Change in Insomnia severity
Description
To identify whether CBTI workshop, self-help CBTI or SHE workshop results in the greatest alleviation of insomnia severity using the Insomnia Severity Index, which allows the patients to rate their perceived severity and satisfaction level towards their current conditions (Arnedt, Cuddihy & Swanson, et al, 2014; Wong, Zhang & Li, et al, 2017).
Time Frame
Baseline assessment (Week 0); Short-term follow-up (Week 8); Long-term follow-up (Week 16)
Secondary Outcome Measure Information:
Title
Change in Symptoms of Mood disorders
Description
To identify which of the 3 therapies brings the largest reduction mood disorders through the Hospital Anxiety and Depression Scale.
Time Frame
Baseline assessment (Week 0); Short-term follow-up (Week 8); Long-term follow-up (Week 16)
Title
Change in Quality of life
Description
To investigate which of the 3 therapies improves the quality of life of patients to the greatest extent using the Short-Form Six-Dimension Health Survey.
Time Frame
Baseline assessment (Week 0); Short-term follow-up (Week 8); Long-term follow-up (Week 16)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Hong Kong residents
Aged 16 or above
Satisfy the DSM-5 criteria for insomnia, i.e. inability to fall or keep asleep, or wake up too early for 3 days or more per week, throughout a minimum period of 1 month (instead of 3 months in the diagnostic criteria D) using the Brief Insomnia Questionnaire. This is to include episodic insomnia which is considered as an 'other specified insomnia disorder' in DSM-5.
Score at least 10 points in Insomnia Severity Index
Able to read and understand Cantonese
Have Internet access
Exclusion Criteria:
Suffer from recently diagnosed and untreated medical, psychiatric or sleep disorders that likely contribute to the onset and maintenance of insomnia, e.g. major depressive disorder, obstructive sleep apnea, restless legs syndrome, chronic pain.
Currently receiving CBTI or SHE
Work on irregular rotational shift
Facility Information:
Facility Name
The University of Hong Kong
City
Hong Kong
Country
Hong Kong
12. IPD Sharing Statement
Learn more about this trial
Low-intensity Cognitive-behavioural Therapy for Insomnia
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