UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014297 |
|---|---|
| Receipt number | 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 17:31:20 |
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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
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
ayabe@ncnp.go.jp
Sponsor or person
Institute
Department of Psychophysiology, National Institute of Mental Health, National Center of Neurology & Psychiatry
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016588
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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