Enhancing Performance of Cognitive Behavioral Therapy for Insomnia With an Integrative Mobile Platform
- Conditions
- Primary InsomniaDepressive Disorders With Insomnia
- Interventions
- Behavioral: Traditional CBT-IBehavioral: App modules
- Registration Number
- NCT01978626
- Lead Sponsor
- National Taiwan University Hospital
- Brief 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. 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 120
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control Traditional CBT-I 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 Smart phone Apps App modules 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
- Primary Outcome Measures
Name Time Method Efficacy of app on CBT-I (The first year) 6 weeks The compliance rate of keeping sleep diary and behavioral prescription.
Efficacy of app on CBT-I (The second year) 6 weeks The efficacy of social persuasion app module on sleep quality
Efficacy of app on CBT-I (The third year) 6 weeks The efficacy of Tai-Chi multi-media app module on sleep quality
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
National Taiwan University Hospital
🇨🇳Taipei, Taiwan