UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000011044
Receipt No. R000012927
Scientific Title Study of the efficacy of cognitive behavior therapy for psychophysiological insomnia
Date of disclosure of the study information 2013/06/26
Last modified on 2015/02/04

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Study of the efficacy of cognitive behavior therapy for psychophysiological insomnia
Acronym Study of the efficacy of cognitive behavior therapy for psychophysiological insomnia
Scientific Title Study of the efficacy of cognitive behavior therapy for psychophysiological insomnia
Scientific Title:Acronym Study of the efficacy of cognitive behavior therapy for psychophysiological insomnia
Region
Japan

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

Objectives
Narrative objectives1 To investigate the efficacy of cognitive behavior therapy for psychophysiological insomnia
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Sleep Log
Actigraph
DBAS (Dysfunctional Beliefs and Attitudes about Sleep)
PSQI (Pittsburgh Sleep Quality Index)
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Behavior,custom
Interventions/Control_1 Cognitive behavior therapy
1) Cognitive therapy
2) Sleep hygiene education
3) Stimulus control therapy
4) Sleep restriction therapy
Interventions/Control_2
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) Patients who have been diagnosed with psychophysiological insomnia according to the diagnostic criteria outlined by International Classification of Sleep Disorders, Second Edition.
2) No gender specification.
3) Patients who have signed consent to participate in this research.
Key exclusion criteria 1) Patients who have Narcolepsy, Sleep apnea syndrome, Restless legs syndrome and Periodic limb movement disorder.
2) Patients with insomnia that accompany Schizophrenia, Manic-depressive psychosis and Epilepsy.
3) Patients with insomnia due to Medical condition.
4) Patients under twenty years of age.
5) Patients with Dementia.
6) Patients who are otherwise classified as unfit by the attending physicians for the research.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name KAZUHIKO NAKAYAMA
Organization The Jikei university school of medicine
Division name Department of Psychiatry
Zip code
Address 3-25-8, Nishi-Shinbashi, Minato-Ku, Tokyo
TEL 03-3433-1111
Email nakayama@jikei.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name DAISUKE HARADA
Organization The Jikei university school of medicine
Division name Department of Psychiatry
Zip code
Address 3-25-8, Nishi-Shinbashi, Minato-Ku, Tokyo
TEL 03-3433-1111
Homepage URL
Email tyo3003@jikei.ac.jp

Sponsor
Institute The Jikei university school of medicine
Institute
Department

Funding Source
Organization Ministry of Health, Labour and Welfare.
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
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

Other administrative information
Date of disclosure of the study information
2013 Year 06 Month 26 Day

Related information
URL releasing protocol
Publication of results Partially published

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 Open public recruiting
Date of protocol fixation
2008 Year 09 Month 01 Day
Date of IRB
Anticipated trial start date
2008 Year 10 Month 04 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 06 Month 26 Day
Last modified on
2015 Year 02 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012927

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.