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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000014297
Receipt No. R000016588
Scientific Title The randomized controlled trial on the efficacy of cognitive behavior therapy for insomnia
Date of disclosure of the study information 2014/06/18
Last modified on 2017/12/20

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Basic information
Public title The randomized controlled trial on the efficacy of cognitive behavior therapy for insomnia
Acronym Cognitive behavior therapy for insomnia
Scientific Title The randomized controlled trial on the efficacy of cognitive behavior therapy for insomnia
Scientific Title:Acronym Cognitive behavior therapy for insomnia
Region
Japan

Condition
Condition Primary insomnia
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the efficacy of cognitive behavioral therapy for insomnia
Basic objectives2 Others
Basic objectives -Others To investigate the efficacy of cognitive behavioral therapy for tapering of hypnotics
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes sleep diary
Insomnia Severity Index
Dose of hypnotics
Key secondary outcomes Actigraph
Pittsburg Sleep Quality Index
Athens Insomnia Scale
Ford Insomnia Response to Stress Test
Short-Form 36-Item Health Survey
Sheehan Disability Scale
Self-rating Depression Scale
K6

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Behavior,custom
Interventions/Control_1 cognitive behavioral therapy
1.sleep diary
2.sleep hygiene
3.sleep scheduling
4.progressive muscle relaxation
5.actigraph

Interventions/Control_2 control
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1.To meet the diagnostic criteria for primary insomnia in DSM-4-TR as a primary diagnostic
2.Score of the Insomnia Severity Index is 8 points or more
3.To suffer from either the sleep latency or wake time after sleep onset is 31 minutes or more, even taking sleeping pills, in at least three days a week just before the entry.
Key exclusion criteria 1. Insomnia that occurs only in the course of other psychiatric disorders (major depressive disorder, schizophrenia cases)
2. Insomnia due to the direct physiological effects of a general medical condition or substance (drug of abuse, medication example)
3. Insomnia that occurs only during the course of other sleep disorders sleep apnea syndrome, restless legs syndrome, circadian rhythm sleep disorders, etc.
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuo MISHIMA
Organization National Institute of Mental Health, National Center of Neurology & Psychiatry
Division name Department of Psychophysiology
Zip code
Address 4-1-1 Ogawa-Higashi, Kodaira, Tokyo, Japan
TEL 042-346-2071
Email mishima@ncnp.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Naoko AYABE
Organization National Institute of Mental Health, National Center of Neurology & Psychiatry
Division name Department of Psychophysiology
Zip code
Address 4-1-1 Ogawa-Higashi, Kodaira, Tokyo, Japan
TEL 042-346-2071
Homepage URL
Email ayabe@ncnp.go.jp

Sponsor
Institute Department of Psychophysiology, National Institute of Mental Health, National Center of Neurology & Psychiatry
Institute
Department

Funding Source
Organization Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor The Jikei University School of Medicine, Sleep total care clinic Yoyogi, Kurume University Hospital
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 東京慈恵会医科大学(東京都)、睡眠総合ケアクリニック代々木(東京都)、久留米大学病院(福岡県)、国立精神・神経医療研究センター(東京都)

Other administrative information
Date of disclosure of the study information
2014 Year 06 Month 18 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2011 Year 07 Month 05 Day
Date of IRB
Anticipated trial start date
2011 Year 09 Month 12 Day
Last follow-up date
Date of closure to data entry
2017 Year 10 Month 11 Day
Date trial data considered complete
2017 Year 12 Month 20 Day
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 06 Month 18 Day
Last modified on
2017 Year 12 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016588

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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