UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The randomized controlled trial on the efficacy of cognitive behavior therapy for insomnia
Title of the study (Brief title)	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	Kazuo MISHIMA
Organization	National Institute of Mental Health, National Center of Neurology & Psychiatry
Division name	Department of Psychophysiology
Address	4-1-1 Ogawa-Higashi, Kodaira, Tokyo, Japan
TEL	042-346-2071
Email	mishima@ncnp.go.jp

Public contact
Name of contact person	Naoko AYABE
Organization	National Institute of Mental Health, National Center of Neurology & Psychiatry
Division name	Department of Psychophysiology
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 07 Month 05 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000016588