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

Primary Purpose

Primary Insomnia, Depressive Disorders With Insomnia

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
App modules
Traditional CBT-I
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Primary Insomnia focused on measuring Insomnia, Comorbid insomnia, Cognitive Behavioral Therapy

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • National Taiwan University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Smart phone Apps

Control

Arm Description

1st year: Electronic sleep diary module: an app with electronic sleep diary and message reminder 2nd year: Social persuasion system module: an app of smart phone that encourages participants with each others 3rd year: Tai-chi module: a multi-media oriented app that helps participants practice Tai-Chi

1st year: traditional paper-pencil diary 2nd year: no social persuasion is given beyond sessions 3rd year: Tai-chi teaching by Digital Video Disc only

Outcomes

Primary Outcome Measures

Efficacy of app on CBT-I (The first year)
The compliance rate of keeping sleep diary and behavioral prescription.
Efficacy of app on CBT-I (The second year)
The efficacy of social persuasion app module on sleep quality
Efficacy of app on CBT-I (The third year)
The efficacy of Tai-Chi multi-media app module on sleep quality

Secondary Outcome Measures

Full Information

First Posted
November 1, 2013
Last Updated
May 7, 2015
Sponsor
National Taiwan University Hospital
Collaborators
National Science Council, Taiwan
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1. Study Identification

Unique Protocol Identification Number
NCT01978626
Brief Title
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

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Unknown status
Study Start Date
March 2014 (undefined)
Primary Completion Date
July 2016 (Anticipated)
Study Completion Date
July 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital
Collaborators
National Science Council, Taiwan

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Insomnia, Depressive Disorders With Insomnia
Keywords
Insomnia, Comorbid insomnia, Cognitive Behavioral Therapy

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Smart phone Apps
Arm Type
Experimental
Arm Description
1st year: Electronic sleep diary module: an app with electronic sleep diary and message reminder 2nd year: Social persuasion system module: an app of smart phone that encourages participants with each others 3rd year: Tai-chi module: a multi-media oriented app that helps participants practice Tai-Chi
Arm Title
Control
Arm Type
Active Comparator
Arm Description
1st year: traditional paper-pencil diary 2nd year: no social persuasion is given beyond sessions 3rd year: Tai-chi teaching by Digital Video Disc only
Intervention Type
Behavioral
Intervention Name(s)
App modules
Intervention Type
Behavioral
Intervention Name(s)
Traditional CBT-I
Primary Outcome Measure Information:
Title
Efficacy of app on CBT-I (The first year)
Description
The compliance rate of keeping sleep diary and behavioral prescription.
Time Frame
6 weeks
Title
Efficacy of app on CBT-I (The second year)
Description
The efficacy of social persuasion app module on sleep quality
Time Frame
6 weeks
Title
Efficacy of app on CBT-I (The third year)
Description
The efficacy of Tai-Chi multi-media app module on sleep quality
Time Frame
6 weeks
Other Pre-specified Outcome Measures:
Title
Satisfaction on app
Description
In the first year, the satisfaction of app design will be surveyed in the experimental arm.
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hsi-Chung Chen, M.D., Ph.D.
Phone
+886-2-23813208
Email
hsichungchen@ntuh.gov.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hsi-Chung Chen, M.D., Ph.D.
Organizational Affiliation
National Taiwan University Hospital, Taipei, Taiwan
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hsi-Chung Chen, M.D., Ph.D.
Phone
+886-2-23813208
Email
hsichungchen@ntuh.gov.tw

12. IPD Sharing Statement

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

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