InsomniaNCT01719120
Internet-Based Cognitive-Behavioral Therapy for Insomnia
A study testing Cognitive-Behavioral Therapy in people with Insomnia, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
The aim of this study is to develop an Internet-based self-help therapy program for insomnia in Chinese language, and to conduct a randomized waiting-list controlled trial on the efficacy of Internet-based self-help therapy for insomnia. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Insomnia
- What is being tested?
- Cognitive-Behavioral Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 312 participants
- Where
- 1 siteHong Kong
- Study dates
- Aug 2012to May 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Hong Kong residents aged ≥18 years
- Predominant complaint of difficulty initiating or maintaining sleep or early morning awakening or nonrestorative sleep with associated distress or impairment in social, occupational and other important areas of functioning for at least 3 nights per week for at least 3 months based on self- administered questionnaire
- Able to read Chinese and type Chinese or English
- Have Internet access (PC/ mobile phone), and with an email address
- Willing to give informed consent and comply with the trial protocol
Who cannot join
- Have suicidal ideas based on self-report
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Internet-Based Self-Help Cognitive-Behavioral Therapy for Insomnia (CBTI): A Randomized Controlled Trial
The aim of this study is to develop an Internet-based self-help therapy program for insomnia in Chinese language, and to conduct a randomized waiting-list controlled trial on the efficacy of Internet-based self-help therapy for insomnia.
Read the detailed description
This study is a randomized controlled trial in patients with insomnia. Eligible subjects will be randomly assigned to self-help treatment with telephone consultation (SHTC), self-help treatment without telephone consultation (SH), or waiting-list control. The subjects will receive self-help treatment once per week for 6 consecutive weeks. In addition to self-help treatment, the subjects in SHTC group will receive telephone consultation once per week for 6 consecutive weeks.
- Conditions
- Insomnia
- Being tested
- Cognitive-Behavioral Therapy
- Keywords
- Insomnia, Cognitive-Behavioral Therapy, Internet-Based, Self-Help, Randomized Controlled Trial
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive-Behavioral TherapyBehavioural
CBT for insomnia aims at changing dysfunctional cognitive beliefs and maladaptive behaviors contributed to the maintenance of insomnia. It involves 4 main components including behavioral, cognitive, educational, and relaxation treatments.
| Study group | Role | What they receive |
|---|---|---|
| Self-help CBT with tel. consultation | Experimental | Self-help CBT with tel. consultation (SHTC)group will receive telephone consultation provided by the investigator in addition to self-help cognitive-behavioral therapy once per week for 6 consecutive weeks.During the consultation, the investigator will answer questions about the treatment content, monitor whether the subjects read the assigned materials and comply with the tasks and procedures, and provide encouragement and support. Receives: Behavioral: Cognitive-Behavioral Therapy |
| Self-help CBT | Experimental | The subjects will receive self-help cognitive-behavioral therapy (SH)once per week for 6 consecutive weeks. Receives: Behavioral: Cognitive-Behavioral Therapy |
| Waiting-list control (WL) | No intervention | Subjects in this group will not receive any kind of treatment during the waiting period. They will receive the treatment identical to the self-help group within 3 months from the baseline. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep parameters (sleep onset latency, sleep efficiency, total sleep time, times of wakening during sleep) changes from baseline to 5-week posttreatment by subjective measures using sleep log.
12-week posttreatment is only for within-group comparison in treatment groups
Measured: Baseline, 1-week, 5-week, and 12-week posttreatment.
Secondary outcomes (10)
Self-rated sleep quality score measured by the Pittsburgh Sleep Quality Index (PSQI) questionnaire
12-week posttreatment is only for within-group comparison in treatment groups
Measured: Baseline, 1-week, 5-week, and 12-week posttreatment.
Self-rated sleep-related cognition score measured by Dysfunctional Beliefs and Attitudes about Sleep Scale (DBAS)
12-week posttreatment is only for within-group comparison in treatment groups
Measured: Baseline, 1-week, 5-week, and 12-week posttreatment.
Self-rated severity of depressive and anxiety symptoms measured by Hospital Anxiety and Depression Scale (HADS)
12-week posttreatment is only for within-group comparison in treatment groups
Measured: Baseline, 1-week, 5-week, and 12-week posttreatment
Subjects' general health and quality of life regarding physical functioning, social functioning, physical role limitations, emotional role limitations, mental health, vitality, bodily pain, and general health perception measured by Short form -36 (SF-36)
12-week posttreatment is only for within-group comparison in treatment groups
Measured: Baseline, 1-week, 5-week, and 12-week posttreatment.
Self-rated fatigue score measured by Multidimensional Fatigue Inventory (MFI)
12-week posttreatment is only for within-group comparison in treatment groups
Measured: Baseline, 1-week, 5-week, and 12-week posttreatment.
Subjects' acceptability and credibility to the treatment measured by Treatment acceptability and credibility rating scale
Measured: Baseline and 1-week posttreatment
Subjects' adherence to the treatment measured by Treatment adherence rating scale
Measured: 1-week posttreatment
Subjects' satisfaction to the treatment measured by Treatment satisfaction rating scale
Measured: Treatment Week 2-6
Potential side effects associated with each component of CBT measured by Symptom checklist
Measured: Treatment Week 2-6 and 1-week posttreatment
Self-rated sleep quality score changes from baseline to 12-week posttreatment measured by Insomnia Severity Index questionnaire
12-week posttreatment is only for within-group comparison in treatment groups
Measured: Baseline, treatment Week 3, 1-week, 5-week and 12 week posttreatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2012 (estimated)
- Study startAug 2012
- Primary completionApr 2014
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InsomniaStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 312 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ka-Fai Chung, MBBS, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01719120
- Sponsor's protocol ID
- CBTI-001
- Status last verified
- May 2016
- First submitted
- 29 Oct 2012
- Last updated
- 13 May 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Ho FY, Chung KF, Yeung WF, Ng TH, Cheng SK. Weekly brief phone support in self-help cognitive behavioral therapy for insomnia disorder: Relevance to adherence and efficacy. Behav Res Ther. 2014 Dec;63:147-56. doi: 10.1016/j.brat.2014.10.002. Epub 2014 Oct 23.
PubMed 25461790
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internet-Based Self-Help Cognitive-Behavioral Therapy for Insomnia (CBTI): A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01719120
- Acronym / sponsor ID
- CBTI-001
- Conditions
- Insomnia
- Keywords
- Insomnia, Cognitive-Behavioral Therapy, Internet-Based, Self-Help, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 312 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Apr 2014 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 1 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to develop an Internet-based self-help therapy program for insomnia in Chinese language, and to conduct a randomized waiting-list controlled trial on the efficacy of Internet-based self-help therapy for insomnia.
Detailed description
This study is a randomized controlled trial in patients with insomnia. Eligible subjects will be randomly assigned to self-help treatment with telephone consultation (SHTC), self-help treatment without telephone consultation (SH), or waiting-list control. The subjects will receive self-help treatment once per week for 6 consecutive weeks. In addition to self-help treatment, the subjects in SHTC group will receive telephone consultation once per week for 6 consecutive weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Self-help CBT with tel. consultation | Experimental | Behavioral: Cognitive-Behavioral TherapySelf-help CBT with tel. consultation (SHTC)group will receive telephone consultation provided by the investigator in addition to self-help cognitive-behavioral therapy once per week for 6 consecutive weeks.During the consultation, the investigator will answer questions about the treatment content, monitor whether the subjects read the assigned materials and comply with the tasks and procedures, and provide encouragement and support. |
| Self-help CBT | Experimental | Behavioral: Cognitive-Behavioral TherapyThe subjects will receive self-help cognitive-behavioral therapy (SH)once per week for 6 consecutive weeks. |
| Waiting-list control (WL) | No intervention | –Subjects in this group will not receive any kind of treatment during the waiting period. They will receive the treatment identical to the self-help group within 3 months from the baseline. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Hong Kong residents aged ≥18 years
- Predominant complaint of difficulty initiating or maintaining sleep or early morning awakening or nonrestorative sleep with associated distress or impairment in social, occupational and other important areas of functioning for at least 3 nights per week for at least 3 months based on self- administered questionnaire
- Able to read Chinese and type Chinese or English
- Have Internet access (PC/ mobile phone), and with an email address
- Willing to give informed consent and comply with the trial protocol
Key exclusion criteria (1 listed)
- Have suicidal ideas based on self-report
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive-Behavioral TherapyCBT for insomnia aims at changing dysfunctional cognitive beliefs and maladaptive behaviors contributed to the maintenance of insomnia. It involves 4 main components including behavioral, cognitive, educational, and relaxation treatments. | Behavioural | Self-help CBT, Self-help CBT with tel. consultation |
Primary outcome
Sleep parameters (sleep onset latency, sleep efficiency, total sleep time, times of wakening during sleep) changes from baseline to 5-week posttreatment by subjective measures using sleep log.
Time frame: Baseline, 1-week, 5-week, and 12-week posttreatment.
12-week posttreatment is only for within-group comparison in treatment groups
10 secondary outcomes
Self-rated sleep quality score measured by the Pittsburgh Sleep Quality Index (PSQI) questionnaire
Time frame: Baseline, 1-week, 5-week, and 12-week posttreatment.
Self-rated sleep-related cognition score measured by Dysfunctional Beliefs and Attitudes about Sleep Scale (DBAS)
Time frame: Baseline, 1-week, 5-week, and 12-week posttreatment.
Self-rated severity of depressive and anxiety symptoms measured by Hospital Anxiety and Depression Scale (HADS)
Time frame: Baseline, 1-week, 5-week, and 12-week posttreatment
Subjects' general health and quality of life regarding physical functioning, social functioning, physical role limitations, emotional role limitations, mental health, vitality, bodily pain, and general health perception measured by Short form -36 (SF-36)
Time frame: Baseline, 1-week, 5-week, and 12-week posttreatment.
Self-rated fatigue score measured by Multidimensional Fatigue Inventory (MFI)
Time frame: Baseline, 1-week, 5-week, and 12-week posttreatment.
Subjects' acceptability and credibility to the treatment measured by Treatment acceptability and credibility rating scale
Time frame: Baseline and 1-week posttreatment
Subjects' adherence to the treatment measured by Treatment adherence rating scale
Time frame: 1-week posttreatment
Subjects' satisfaction to the treatment measured by Treatment satisfaction rating scale
Time frame: Treatment Week 2-6
Potential side effects associated with each component of CBT measured by Symptom checklist
Time frame: Treatment Week 2-6 and 1-week posttreatment
Self-rated sleep quality score changes from baseline to 12-week posttreatment measured by Insomnia Severity Index questionnaire
Time frame: Baseline, treatment Week 3, 1-week, 5-week and 12 week posttreatment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2016.
- Results publication: PubMed 25461790Ho FY, Chung KF, Yeung WF, Ng TH, Cheng SK. Weekly brief phone support in self-help cognitive behavioral therapy for insomnia disorder: Relevance to adherence and efficacy. Behav Res Ther. 2014 Dec;63:147-56. doi: 10.1016/j.brat.2014.10.002. Epub 2014 Oct 23.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ka-Fai Chung, MBBS principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive-Behavioral Therapy in people with Insomnia, run by The University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep parameters (sleep onset latency, sleep efficiency, total sleep time, times of wakening during sleep) changes from baseline to 5-week posttreatment by subjective measures using sleep log. (time frame: Baseline, 1-week, 5-week, and 12-week posttreatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01719120, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2016.