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

Primary Insomnia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01978626
• Other study ID #: 201307042RINC
• Status: Recruiting
• Phase: N/A
• First received: November 1, 2013
• Last updated: May 7, 2015
• Start date: March 2014
• Est. completion date: July 2016

Study information

• Verified date: May 2015
• Source: National Taiwan University Hospital
• Contact: Hsi-Chung Chen, M.D., Ph.D.
• Phone: +886-2-23813208
• Email: hsichungchen[@]ntuh.gov.tw
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical 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. 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorders With Insomnia
• Primary Insomnia

Intervention

Behavioral:
• App modules

• Traditional CBT-I

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (2)

Lead Sponsor	Collaborator
National Taiwan University Hospital	National Science Council, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Satisfaction on app	In the first year, the satisfaction of app design will be surveyed in the experimental arm.	6 weeks	No
Primary	Efficacy of app on CBT-I (The first year)	The compliance rate of keeping sleep diary and behavioral prescription.	6 weeks	No
Primary	Efficacy of app on CBT-I (The second year)	The efficacy of social persuasion app module on sleep quality	6 weeks	No
Primary	Efficacy of app on CBT-I (The third year)	The efficacy of Tai-Chi multi-media app module on sleep quality	6 weeks	No