UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011044 |
|---|---|
| Receipt number | 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 17:45:26 |
* 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
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
tyo3003@jikei.ac.jp
Sponsor or person
Institute
The Jikei university school of medicine
Institute
Department
Personal name
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
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
Value
https://center6.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 |
