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

May 7, 2015 updated by: National Taiwan University Hospital
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan, 100
        • Recruiting
        • National Taiwan University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Behavioral: App modules
Active Comparator: 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
Behavioral: Traditional CBT-I

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy of app on CBT-I (The first year)
Time Frame: 6 weeks
The compliance rate of keeping sleep diary and behavioral prescription.
6 weeks
Efficacy of app on CBT-I (The second year)
Time Frame: 6 weeks
The efficacy of social persuasion app module on sleep quality
6 weeks
Efficacy of app on CBT-I (The third year)
Time Frame: 6 weeks
The efficacy of Tai-Chi multi-media app module on sleep quality
6 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Satisfaction on app
Time Frame: 6 weeks
In the first year, the satisfaction of app design will be surveyed in the experimental arm.
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Collaborators

National Science Council, Taiwan

Investigators

  • Principal Investigator: Hsi-Chung Chen, M.D., Ph.D., National Taiwan University Hospital, Taipei, Taiwan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (Anticipated)

July 1, 2016

Study Completion (Anticipated)

July 1, 2016

Study Registration Dates

First Submitted

November 1, 2013

First Submitted That Met QC Criteria

November 1, 2013

First Posted (Estimate)

November 7, 2013

Study Record Updates

Last Update Posted (Estimate)

May 8, 2015

Last Update Submitted That Met QC Criteria

May 7, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201307042RINC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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