UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The randomized controlled trial on the efficacy of mobile-app delivered cognitive behavioral therapy for insomnia
Title of the study (Brief title)	Mobile-app delivered cognitive behavioral therapy for insomnia
Region	Japan

Condition
Condition	Insomnia
Classification by specialty	Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Investigate the efficacy of mobile-app delivered cognitive behavioral therapy for insomnia
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Athens Insomnia Scale
Key secondary outcomes	Sleep diary Quick Inventory of Depressive Symptomatology (QIDS) Actigraph Epwarth sleepiness scale psychomotor vigilance task (PVT)

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Numbered container method

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	Mobile-app delivered cognitive behavioral therapy (8 weeks) 1. sleep diary 2. sleep hygiene 3. sleep restriction therapy 4. stimulus control therapy 5. cognitive therapy 6. relaxation 7. actigraph
Interventions/Control_2	Control (8 weeks) 1. sleep diary 2. sleep hygiene 3. actigraph
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Score of the Athens insomnia scale is 6 points or more
Key exclusion criteria	Unable to use smartphone circadian rhythm disorder sleep apnea syndrome Restless legs syndrome hypersomnia
Target sample size	40

Research contact person
Name of lead principal investigator	Taro Ueno
Organization	Neuropsychiatric Research Institute
Division name	Seiwa Hospital
Address	Bentencho 91, Shinjuku, Tokyo
TEL	+81-3-3260-9171
Email	t-ueno@umin.ac.jp

Public contact
Name of contact person	Taro Ueno
Organization	Neuropsychiatric Research Institute
Division name	Seiwa Hospital
Address	Bentencho 91, Shinjuku, Tokyo
TEL	+81-3-3260-9171
Homepage URL
Email	t-ueno@umin.ac.jp

Sponsor
Institute	Neuropsychiatric Research Institute
Institute
Department

Funding Source
Organization	New Energy and Industrial Technology Development Organization (NEDO)
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	Kuwamizu Hospital
Name of secondary funｄer(s)	Sustainable Medicine, Inc. DeSC Healthcare, Inc.

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	晴和病院（東京都）、くわみず病院（熊本県）

Other administrative information
Date of disclosure of the study information	2016 Year 09 Month 12 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 07 Month 26 Day
Anticipated trial start date	2016 Year 09 Month 12 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 09 Month 10 Day
Last modified on	2018 Year 05 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027629