UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038030 |
|---|---|
| Receipt number | R000043315 |
| Scientific Title | Evaluation of the effectiveness of an intervention for people with addiction to reduce risks in their public speaking |
| Date of disclosure of the study information | 2019/09/18 |
| Last modified on | 2020/03/19 12:51:28 |
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Basic information
Public title
Evaluation of the effectiveness of an educational program for people with addiction's safer public speaking
Acronym
Evaluation of the effectiveness of an educational program for people with addiction's safer public speaking
Scientific Title
Evaluation of the effectiveness of an intervention for people with addiction to reduce risks in their public speaking
Scientific Title:Acronym
Evaluation of the effectiveness of an intervention for people with addiction to reduce risks in their public speaking
Region
| Japan |
Condition
Condition
Addictive disorders
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to investigate the effectiveness of an educational program for people with addiction on their public speaking in reducing psychological distress and risks of relapse and unfavourable social consequences.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The Total Mood Disturbance (TMD) score of the Profile of Mood States 2nd Edition (POMS2) measured a week after the intervention
Key secondary outcomes
The following measurements will be assessed a week after the intervention.
- Self-consciousness scale (4 items)
- Risk perception (2 items)
- Knowledge on psychological readiness (1 item)
- Self-determination (1 item)
- Motive identification (1 item)
- Self-efficacy (2 items)
- Motivation (1 item)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
The intervention is a 5 hour-long educational program, which will be conducted in one day, with at least 5 and up to 30 participants at a time. The program includes lectures and group discussions for participants to learn on the risks related to public speaking, its context, and preventive and coping strategies.
Interventions/Control_2
No intervention.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Self-reported experience of substance or behavioural addiction
2) Interested in public speaking on own experience of addiction
3) Providing written informed consent by free will with sufficient understanding in the study purpose and procedure
Key exclusion criteria
1) Unable to obtain informed consent and/ or answer the questionnaires due to health conditions
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Hiroya |
| Middle name | |
| Last name | Matsuo |
Organization
Graduate School of Health Sciences, Kobe University
Division name
Department of Public Health
Zip code
654-0142
Address
7-10-2, Tomogaoka, Suma-ward, Kobe city
TEL
078-796-4525
matsuoh@tiger.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | Chika |
| Middle name | |
| Last name | Tanaka |
Organization
Graduate School of Health Sciences, Kobe University
Division name
Department of Public Health
Zip code
654-0142
Address
7-10-2, Tomogaoka, Suma-ward, Kobe city
TEL
08024355033
Homepage URL
chika128@people.kobe-u.ac.jp
Sponsor or person
Institute
Graduate School of Health Sciences, Kobe University
Institute
Department
Personal name
Funding Source
Organization
The Uehiro Foundation on Ethics and Education
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Kobe Drug Addiction Rehabilitation Center
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Ethical Committee of the Graduate School of Health Sciences, Kobe University
Address
7-10-2, Tomogaoka, Suma-ward, Kobe city
Tel
078-796-4502
syomu2@ams.kobe-u.ac.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 | 09 | Month | 18 | 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
No longer recruiting
Date of protocol fixation
| 2019 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 08 | Month | 30 | Day |
Anticipated trial start date
| 2019 | Year | 09 | Month | 06 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 14 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 09 | Month | 18 | Day |
Last modified on
| 2020 | Year | 03 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043315
| 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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