Enhancing Performance of Cognitive Behavioral Therapy for Insomnia With an Integrative Mobile Platform

Study Overview
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Brief Summary
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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
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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.

Official Title
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Enhancing Performance of Cognitive Behavioral Therapy for Insomnia With an Integrative Mobile Platform

Conditions
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Primary Insomnia, Depressive Disorders With Insomnia

Intervention / Treatment
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* Behavioral: App modules
* Behavioral: Traditional CBT-I


Participation Criteria
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Eligibility Criteria
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First and second year: Inclusion criteria: 20 and more years old meet Diagnostic and Statistical Manual-IV diagnostic criteria for primary insomnia Exclusion criteria: not current smart phone users Third year: Inclusion criteria: 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) Exclusion criteria: with high suicide risk not current smart phone users

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Smart phone Apps<br>1st year: Electronic sleep diary module: an app with electronic sleep diary and message reminder 2nd year: Social persuasion system module: an app of smart phone that encourages participants with each others 3rd year: Tai-chi module: a multi-media oriented app that helps participants practice Tai-Chi | Behavioral: App modules<br> <br> |
| Active Comparator: Control<br>1st year: traditional paper-pencil diary 2nd year: no social persuasion is given beyond sessions 3rd year: Tai-chi teaching by Digital Video Disc only | Behavioral: Traditional CBT-I<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of app on CBT-I (The first year) | The compliance rate of keeping sleep diary and behavioral prescription. | 6 weeks | 
| Efficacy of app on CBT-I (The second year) | The efficacy of social persuasion app module on sleep quality | 6 weeks | 
| Efficacy of app on CBT-I (The third year) | The efficacy of Tai-Chi multi-media app module on sleep quality | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Insomnia, Comorbid insomnia, Cognitive Behavioral Therapy