UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The intervention of both depression and insomnia of caregivers of dementia patients with behaviors problems
Title of the study (Brief title)	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)

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Shutaro Nakaaki
Organization	Toda hospital
Division name	Psychiatry
Address	Nizominami, Toda-city, Saitama, 335-0026, JAPAN
TEL	048-442-3824
Email	hzi05510@nifty.com

Public contact
Name of contact person	Masatoshi Hayashi
Organization	Toda hospital
Division name	Psychiatry
Address	Nizominami, Toda-city, Saitama, 335-0026, JAPAN
TEL	048-442-3824
Homepage URL
Email	masatohaya@gmail.com

Sponsor
Institute	Toda hospital
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 11 Month 19 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-bin/icdr_e/ctr_view.cgi?recptno=R000015975