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

National Taiwan University

Status: Unknown

Conditions: Depressive Disorders With Insomnia; Primary Insomnia

Treatments: Behavioral: App modules; Behavioral: Traditional CBT-I

Study type: Interventional

Funder types: Other

Identifiers

NCT01978626

201307042RINC

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Smart phone Apps

Experimental group

Description:

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

Treatment:

Behavioral: App modules

Control

Active Comparator group

Description:

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

Treatment:

Behavioral: Traditional CBT-I