Depressive Disorders With Insomnia, Primary Insomnia
Conditions
Keywords
Insomnia, Comorbid insomnia, Cognitive Behavioral Therapy
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.
Interventions
BEHAVIORALApp modules
BEHAVIORALTraditional CBT-I
Sponsors
National Science and Technology Council, Taiwan
National Taiwan University Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Satisfaction on app | 6 weeks | In the first year, the satisfaction of app design will be surveyed in the experimental arm. |
Countries
Taiwan
Contacts
Primary ContactHsi-Chung Chen, M.D., Ph.D.
Outcome results
None listed