UMIN-CTR Clinical Trial

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
Email	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
Email	chika128@people.kobe-u.ac.jp

Sponsor
Institute	Graduate School of Health Sciences, Kobe University
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000043315