Clinical trial NCT01978626: Enhancing Performance of Cognitive Behavioral Therapy for Insomnia With an Integrative Mobile Platform
Official title: Enhancing Performance of Cognitive Behavioral Therapy for Insomnia With an Integrative Mobile Platform
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Primary Insomnia
Depressive Disorders With Insomnia
Keywords: Insomnia
Comorbid insomnia
Cognitive Behavioral Therapy
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
Collaborators: name: National Science and Technology Council, Taiwan
First posted: 2013-11-07
Enrollment: 120
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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)

Exclusion criteria:

* with high suicide risk
* not current smart phone users

Primary outcomes:
measure: Efficacy of app on CBT-I (The first year)
timeFrame: 6 weeks
measure: Efficacy of app on CBT-I (The second year)
timeFrame: 6 weeks
measure: Efficacy of app on CBT-I (The third year)
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
measure: Satisfaction on app
timeFrame: 6 weeks
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital, Taipei, Taiwan
name: Hsi-Chung Chen, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: