UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013685 |
|---|---|
| Receipt number | R000015975 |
| Scientific Title | The intervention of both depression and insomnia of caregivers of dementia patients with behaviors problems |
| Date of disclosure of the study information | 2014/04/10 |
| Last modified on | 2016/04/10 09:03:45 |
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Basic information
Public title
The intervention of both depression and insomnia of caregivers of dementia patients with behaviors problems
Acronym
The intervention of both depression and insomnia of caregivers of dementia
Scientific Title
The intervention of both depression and insomnia of caregivers of dementia patients with behaviors problems
Scientific Title:Acronym
The intervention of both depression and insomnia of caregivers of dementia
Region
| Japan |
Condition
Condition
Dementia
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We aimed to evaluate combined a cognitive behavior program and a behavior management program with
dementia patients with behavior problems
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Beck depression inventory II (BDI-II)
Pittsburgh sleep quality index (PSQI)
Neuropsychiatry inventory (NPI)
Key secondary outcomes
Zarit Caregiver Burden Interview (ZBI)
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 | Maneuver | Other |
Interventions/Control_1
Cognitive Behavioral 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
| 40 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
the chief caregiver of dementia patients is the patients family, reliable informed consent could be obtained from the patient and or his her relatives,
Key exclusion criteria
taking antipsychotic or antidepressant medication,There was a previous history of mental illness or substance abuse, the patient has pacemaker, other findings in terms with the aims of this study
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shutaro Nakaaki |
Organization
Toda hospital
Division name
Psychiatry
Zip code
Address
Nizominami, Toda-city, Saitama, 335-0026, JAPAN
TEL
048-442-3824
hzi05510@nifty.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masatoshi Hayashi |
Organization
Toda hospital
Division name
Psychiatry
Zip code
Address
Nizominami, Toda-city, Saitama, 335-0026, JAPAN
TEL
048-442-3824
Homepage URL
masatohaya@gmail.com
Sponsor or person
Institute
Toda hospital
Institute
Department
Personal name
Funding Source
Organization
Meiji Yasuda Mental Health Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
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
高仁会 戸田病院 (埼玉県）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 04 | Month | 10 | 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
| 2013 | Year | 11 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 04 | Month | 10 | Day |
Last follow-up date
| 2016 | Year | 03 | Month | 30 | Day |
Date of closure to data entry
| 2016 | Year | 03 | Month | 30 | Day |
Date trial data considered complete
| 2016 | Year | 03 | Month | 30 | Day |
Date analysis concluded
| 2016 | Year | 03 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 04 | Month | 10 | Day |
Last modified on
| 2016 | Year | 04 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015975
