UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	attempt to develop a new family-assessment by means of realtime biological indices
Title of the study (Brief title)	a family-assessment by biological indices
Region	Japan

Condition
Condition	social anxiety disorder, adjustment disorder, eating disorder
Classification by specialty	Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To assess the effects of realtime biological indices for family-assessment at the begining of family therapy for mental disorders
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	some psychological examinations (e.g. Family Assessment Device Profile of Mood States) directly before family therapy and six months after the begining of family therapy
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	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	Seven family therapy sessions of 60 minites will be conducted every 2 weeks.
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	8 years-old <=
Age-upper limit	30 years-old >
Gender	Male and Female
Key inclusion criteria	patients who are diagnosed as social anxiety disorder, adjustment disorder or eating disorder by DMS-5 and recommended family therapy by their psychiatrists in charge, and whose both parents can attend each session of family therapy
Key exclusion criteria	Exclusion criteria are not established.
Target sample size	2

Research contact person
Name of lead principal investigator	Tomoko MURAMATSU
Organization	Kyoto Notre Dame University
Division name	Department of Psychology
Address	1, Shimogamo-Minaminonogamicho, Sakyo-ku, Kyoto
TEL	075-706-3680
Email	Muratomo@notredame.ac.jp

Public contact
Name of contact person	Tomoko MURAMATSU
Organization	Kyoto Notre Dame University
Division name	Department of Psychology
Address	1, Shimogamo-Minaminonogamicho, Sakyo-ku, Kyoto
TEL	075-706-3680
Homepage URL
Email	Muratomo@notredame.ac.jp

Sponsor
Institute	Department of Psychology, Kyoto Notre Dame University
Institute
Department

Funding Source
Organization	the Ministry of Education, Culture, Sports, Science and Technology Kyoto Notre Dame University
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	Grants-in-Aid for Scientific Research

Other related organizations
Co-sponsor	Iwakura Hospital
Name of secondary funｄer(s)	Kyoto University

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	2018 Year 03 Month 18 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2017 Year 09 Month 06 Day
Anticipated trial start date	2018 Year 05 Month 01 Day
Last follow-up date	2020 Year 03 Month 31 Day
Date of closure to data entry	2020 Year 03 Month 31 Day
Date trial data considered complete	2020 Year 03 Month 31 Day
Date analysis concluded	2020 Year 03 Month 31 Day

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
Other related information

Management information
Registered date	2018 Year 03 Month 18 Day
Last modified on	2018 Year 03 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036265