UMIN-CTR Clinical Trial

Basic information
Public title	study of the effects of the counselors verbal communication
Acronym	study of of the counselors verbal communication
Scientific Title	An analogue study of the effects of the counselors verbal communication in early sessions on the therapeutic relationship
Scientific Title:Acronym	study of verbal communication
Region	Japan

Condition
Condition	Depressive disorder, healthy control
Classification by specialty	Psychiatry Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This study aimed to verify the effects of therapists affirmation on clients views of the therapeutic relationship by using a videos of stimulated psychotherapy.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Counselor Rating Form-Short Version, Session Evaluation Questionnaire
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	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Other
Interventions/Control_1	Participants watched the videos which counselors statements differed. After watching the videos, they evaluated the therapists verbal communication.
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	60 years-old >=
Gender	Male and Female
Key inclusion criteria	Participants with depressive disorder or depressive symptoms, with no history of any mental disorder.
Key exclusion criteria	Participants with comorbid psychiatric disorders except for anxiety disorders and those with a prior medical history of central nervous system disease, severe nervous diseases, more than moderate intellectual disability, and dementia were excluded.
Target sample size	50

Research contact person
Name of lead principal investigator	1st name YOSHIDA Middle name Last name SUMIKO
Organization	National Center of Neurology and Psychiatry
Division name	Clinical Laboratory Department
Zip code	187-8551
Address	4-1-1, Ogawa-Higashi
TEL	0423412711
Email	syoshida@ncnp.go.jp

Public contact
Name of contact person	1st name YOKOTA Middle name Last name YUUKI
Organization	National Center of Neurology and Psychiatry
Division name	Department of Mental Disorder Research, National Institute of Neuroscience
Zip code	187-8551
Address	4-1-1, Ogawa-Higashi
TEL	0423412711
Homepage URL
Email	y_yokota@ncnp.go.jp

Sponsor
Institute	National Center of Neurology and Psychiatry
Institute
Department

Funding Source
Organization	National Center of Neurology and Psychiatry
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	National Center of Neurology and Psyachitry
Address	4-1-1, Ogawa-Higashi
Tel	0423412711
Email	y_yokota@ncnp.go.jp

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	2019 Year 08 Month 15 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications
Number of participants that the trial has enrolled	32
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	2018 Year 12 Month 15 Day
Date of IRB	2019 Year 01 Month 31 Day
Anticipated trial start date	2019 Year 07 Month 01 Day
Last follow-up date	2019 Year 10 Month 31 Day
Date of closure to data entry	2019 Year 11 Month 01 Day
Date trial data considered complete
Date analysis concluded	2020 Year 03 Month 04 Day

Other
Other related information

Management information
Registered date	2019 Year 08 Month 01 Day
Last modified on	2020 Year 08 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000042568