Primary InsomniaNCT01978626
Enhancing Performance of Cognitive Behavioral Therapy for Insomnia With an Integrative Mobile Platform
A study testing App modules and Traditional CBT-I in people with Primary Insomnia and Depressive Disorders With Insomnia, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Cognitive Behavioral Therapy for Insomnia (CBT-I) has been proven as an effective intervention for the non-pharmacological treatment of insomnia. This study hypothesizes app programs of smart phone would enhance the compliance and performance of behavioral intervention of CBT-I. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Primary Insomnia, Depressive Disorders With Insomnia
- What is being tested?
- App modules and Traditional CBT-I
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTaiwan
- Study dates
- Mar 2014to Jul 2016
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 20 and more years old
- meet Diagnostic and Statistical Manual-IV diagnostic criteria for primary insomnia
- 20 and more years old
- meet Diagnostic and Statistical Manual-IV diagnostic criteria for depressive disorders (major depressive disorder or dysthymic disorder)
- mild to moderate severity of depression (Beck Depression Inventory: 13 and more but less than 29)
- mild anxiety symptoms (Bexk Anxiety Inventory: less than 10)
Who cannot join
- not current smart phone users
- Third year:
- with high suicide risk
- not current smart phone users
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, 100
Hsi-Chung Chen, M.D., Ph.D., +886-2-23813208, hsichungchen@ntuh.gov.tw
About this study
Cognitive Behavioral Therapy for Insomnia (CBT-I) has been proven as an effective intervention for the non-pharmacological treatment of insomnia. This study hypothesizes app programs of smart phone would enhance the compliance and performance of behavioral intervention of CBT-I. During a 3-year study period, 3 app modules, including electronic sleep diary along with message reminder system, social persuasion system and Tai-Chi practice system will be tested subsequently for their efficacy.
Read the detailed description
This study comprises 3 parts which are designed as an open-label, active-control study. In each year, the participants in the experimental arm receive app-assisted CBT-I. In the first year, participants with primary insomnia are recruited and assigned to the experimental arm or the active-control arm with matched age, gender and education status. The subject number in each arm is 20. Participants in each arm receive a 6-week standard CBT-I. In the experimental arm, the participants use electronic sleep diary and message reminder to record sleep pattern. In the active-control group, the participants use traditional paper-pencil sleep diary instead. In the second year, participants with primary insomnia are recruited and assigned to the experimental arm or the active-control arm with matched age, gender and education status. The subject number in each arm is 20. Participants in each arm receive a 6-week standard CBT-I. In the experimental arm, the participants use app with function of social persuasion to encourage each other. In the active-control group, no social persuasion is given beyond the treatment sessions. In the third year, participants with comorbid depressive disorder and insomnia are recruited and assigned to the experimental arm or the active-control arm with matched age, gender and education status. The subject number in each arm is 20. Participants in each arm receive a 6-week standard CBT-I. In the experimental arm, the participants use app module that provides a multi-media assisted Tai-Chi video to practice Tai-Chi. In the active-control group, a traditional Tai-CHi teaching digital video disc is provided to help the participants practice Tai-Chi.
- Being tested
- App modules, Traditional CBT-I
- Keywords
- Insomnia, Comorbid insomnia, Cognitive Behavioral Therapy
- 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.
App modulesBehavioural
Traditional CBT-IBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Smart phone Apps | Experimental | 1. 1st year: Electronic sleep diary module: an app with electronic sleep diary and message reminder
2. 2nd year: Social persuasion system module: an app of smart phone that encourages participants with each others
3. 3rd year: Tai-chi module: a multi-media oriented app that helps participants practice Tai-Chi Receives: Behavioral: App modules |
| Control | Active comparator | 1. 1st year: traditional paper-pencil diary
2. 2nd year: no social persuasion is given beyond sessions
3. 3rd year: Tai-chi teaching by Digital Video Disc only Receives: Behavioral: Traditional CBT-I |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of app on CBT-I (The first year)
The compliance rate of keeping sleep diary and behavioral prescription.
Measured: 6 weeks
Efficacy of app on CBT-I (The second year)
The efficacy of social persuasion app module on sleep quality
Measured: 6 weeks
Efficacy of app on CBT-I (The third year)
The efficacy of Tai-Chi multi-media app module on sleep quality
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2013 (estimated)
- Study startMar 2014
- Primary completionJul 2016 (estimated)
- Study completionJul 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary InsomniaStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Responsible party
- Sponsor
- Investigators
- Hsi-Chung Chen, M.D., Ph.D., Principal investigator, National Taiwan University Hospital, Taipei, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01978626
- Sponsor's protocol ID
- 201307042RINC
- Status last verified
- May 2015
- First submitted
- 1 Nov 2013
- Last updated
- 8 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Performance of Cognitive Behavioral Therapy for Insomnia With an Integrative Mobile Platform
- ClinicalTrials.gov ID
- NCT01978626
- Acronym / sponsor ID
- 201307042RINC
- Keywords
- Insomnia, Comorbid insomnia, Cognitive Behavioral Therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Study start
- Mar 2014
- Primary completion
- Jul 2016 (estimated)
- Study completion
- Jul 2016 (estimated)
- First posted
- 7 Nov 2013 (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.
Cognitive Behavioral Therapy for Insomnia (CBT-I) has been proven as an effective intervention for the non-pharmacological treatment of insomnia. This study hypothesizes app programs of smart phone would enhance the compliance and performance of behavioral intervention of CBT-I. During a 3-year study period, 3 app modules, including electronic sleep diary along with message reminder system, social persuasion system and Tai-Chi practice system will be tested subsequently for their efficacy.
Detailed description
This study comprises 3 parts which are designed as an open-label, active-control study. In each year, the participants in the experimental arm receive app-assisted CBT-I. In the first year, participants with primary insomnia are recruited and assigned to the experimental arm or the active-control arm with matched age, gender and education status. The subject number in each arm is 20. Participants in each arm receive a 6-week standard CBT-I. In the experimental arm, the participants use electronic sleep diary and message reminder to record sleep pattern. In the active-control group, the participants use traditional paper-pencil sleep diary instead. In the second year, participants with primary insomnia are recruited and assigned to the experimental arm or the active-control arm with matched age, gender and education status. The subject number in each arm is 20. Participants in each arm receive a 6-week standard CBT-I. In the experimental arm, the participants use app with function of social persuasion to encourage each other. In the active-control group, no social persuasion is given beyond the treatment sessions. In the third year, participants with comorbid depressive disorder and insomnia are recruited and assigned to the experimental arm or the active-control arm with matched age, gender and education status. The subject number in each arm is 20. Participants in each arm receive a 6-week standard CBT-I. In the experimental arm, the participants use app module that provides a multi-media assisted Tai-Chi video to practice Tai-Chi. In the active-control group, a traditional Tai-CHi teaching digital video disc is provided to help the participants practice Tai-Chi.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Smart phone Apps | Experimental | Behavioral: App modules1. 1st year: Electronic sleep diary module: an app with electronic sleep diary and message reminder 2. 2nd year: Social persuasion system module: an app of smart phone that encourages participants with each others 3. 3rd year: Tai-chi module: a multi-media oriented app that helps participants practice Tai-Chi |
| Control | Active comparator | Behavioral: Traditional CBT-I1. 1st year: traditional paper-pencil diary 2. 2nd year: no social persuasion is given beyond sessions 3. 3rd year: Tai-chi teaching by Digital Video Disc only |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 20 and more years old
- meet Diagnostic and Statistical Manual-IV diagnostic criteria for primary insomnia
- 20 and more years old
- meet Diagnostic and Statistical Manual-IV diagnostic criteria for depressive disorders (major depressive disorder or dysthymic disorder)
- mild to moderate severity of depression (Beck Depression Inventory: 13 and more but less than 29)
Key exclusion criteria (4 listed)
- not current smart phone users
- with high suicide risk
- not current smart phone users
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 |
|---|---|---|
| App modules | Behavioural | Smart phone Apps |
| Traditional CBT-I | Behavioural | Control |
Primary outcome
Efficacy of app on CBT-I (The first year)
Time frame: 6 weeks
The compliance rate of keeping sleep diary and behavioral prescription.
Efficacy of app on CBT-I (The second year)
Time frame: 6 weeks
The efficacy of social persuasion app module on sleep quality
Efficacy of app on CBT-I (The third year)
Time frame: 6 weeks
The efficacy of Tai-Chi multi-media app module on sleep quality
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2015.
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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.
Hsi-Chung Chen, M.D., Ph.D. principal investigator
National Taiwan University Hospital, Taipei, Taiwan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing App modules and Traditional CBT-I in people with Primary Insomnia and Depressive Disorders With Insomnia, run by National Taiwan University Hospital at 1 site in Taiwan.
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 6 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 8 May 2015. 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 Taiwan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hsi-Chung Chen, M.D., Ph.D. (+886-2-23813208, hsichungchen@ntuh.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of app on CBT-I (The first year) (time frame: 6 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 May 2015.