UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037566 |
|---|---|
| Receipt number | R000042568 |
| Scientific Title | An analogue study of the effects of the counselors verbal communication in early sessions on the therapeutic relationship |
| Date of disclosure of the study information | 2019/08/15 |
| Last modified on | 2020/08/03 10:23:28 |
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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
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
y_yokota@ncnp.go.jp
Sponsor or person
Institute
National Center of Neurology and Psychiatry
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042568
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
