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

NCT ID: NCT01978626

Last Updated: 2015-05-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-31
• Study Completion Date: 2016-07-31

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.

Conditions

Primary Insomnia; Depressive Disorders With Insomnia

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Smart phone Apps

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

Group Type: EXPERIMENTAL

App modules

Intervention Type: BEHAVIORAL

Control

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

Group Type: ACTIVE_COMPARATOR

Traditional CBT-I

Intervention Type: BEHAVIORAL

Interventions

App modules

Intervention Type: BEHAVIORAL

Traditional CBT-I

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 20 and more years old
• meet Diagnostic and Statistical Manual-IV diagnostic criteria for primary insomnia

• 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

• not current smart phone users

Third year:

• with high suicide risk
• not current smart phone users

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Science and Technology Council, Taiwan

OTHER_GOV

Sponsor Role: collaborator

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hsi-Chung Chen, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University Hospital, Taipei, Taiwan

Locations

National Taiwan University Hospital

Taipei, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Hsi-Chung Chen, M.D., Ph.D.

Role: CONTACT

hsichungchen@ntuh.gov.tw

+886-2-23813208

Facility Contacts

Hsi-Chung Chen, M.D., Ph.D.

Role: primary

hsichungchen@ntuh.gov.tw

+886-2-23813208

Other Identifiers

201307042RINC

Identifier Type: -

Identifier Source: org_study_id