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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000043702
Receipt No. R000049486
Scientific Title The development of a psychoeducational program for suicide prevention by targeting self-image
Date of disclosure of the study information 2021/03/22
Last modified on 2021/03/21

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Basic information
Public title The development of a psychoeducational program for suicide prevention by targeting self-image
Acronym The development of a psychoeducational program for suicide prevention by targeting self-image
Scientific Title The development of a psychoeducational program for suicide prevention by targeting self-image
Scientific Title:Acronym The development of a psychoeducational program for suicide prevention by targeting self-image
Region
Japan

Condition
Condition Suicidal ideation
Classification by specialty
Psychiatry Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to develop a suicide prevention psychoeducational program for Japanese university students, which targert the self-image.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1. Mini-International Neuropsychiatric Interview
2. Patient Health Questionnaire-9
3. Beck Hoplessness Scale
(Before intervention, After intervention, 4 weeks after intervention)
Key secondary outcomes 1. Rosenberg Self-Esteem Scale (RSES-Mimura & Griffiths, 2007)
2.Self-Compassion Scale ( SCS-Arimitsu, 2014)
3. The Self-directedness subscale of the Temperament and Character Inventory (TCI-Kijima et al., 1996)
(Before intervention, After intervention, 4 weeks after intervention)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Behavior,custom
Interventions/Control_1 Students will participate in a 60-minute session once a week for a total of four times. There will be a homework assignment after each session and the homework will be checked at the beginning of the next session. The content of the psychoeducational program is developed around self-esteem, self-compassion and cognitive behavioral therapy.
Session 1: Self-esteem and self-compassion
Session 2: Cognitive distortion
Session 3: Criticism of others and self-criticism
Session 4: Suicide Prevention and Program Summary
Interventions/Control_2 Waiting list control
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
30 years-old >
Gender Male and Female
Key inclusion criteria 1. University students or graduate students enrolled at Hokkaido University
2.Students who received a mental health consultation at Hokkaido University Health Center
3. PHQ-9 total score is 20 points or less
4. Item 9 of PHQ-9 (which assess suicidal ideation) is 1-2 points.
Key exclusion criteria 1. The total score of PHQ-9 is more than 20 points.
2. Item 9 of PHQ-9 is 0 or 3 points
3.Patients who are judged by the attending physician to be unsuitable to participate in the study.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name Nobuyuki
Middle name
Last name Mitsui
Organization Graduate School of Medicine, Hokkaido University
Division name Department of Psychiatry
Zip code 060-8638
Address Kita 15, Nishi 7, Kita-ku, Sapporo, Hokkaido
TEL 011-706-5160
Email nmitsui@med.hokudai.ac.jp

Public contact
Name of contact person
1st name Nobuyuki
Middle name
Last name Mitsui
Organization Graduate School of Medicine, Hokkaido University
Division name Department of Psychiatry
Zip code 060-8638
Address Kita 15, Nishi 7, Kita-ku, Sapporo, Hokkaido
TEL 011-706-5160
Homepage URL
Email nmitsui@med.hokudai.ac.jp

Sponsor
Institute Hokkaido University
Institute
Department

Funding Source
Organization The Mental Health Okamoto Memorial Foundation
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Ethical Committee of Hokkaido University Graduate School of Medicine
Address Kita 15, Nishi 7, Kita-ku, Sapporo, Hokkaido
Tel 011-706-5003
Email shomu@med.hokudai.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 北海道大学保健センター

Other administrative information
Date of disclosure of the study information
2021 Year 03 Month 22 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 Preinitiation
Date of protocol fixation
2020 Year 10 Month 29 Day
Date of IRB
Anticipated trial start date
2021 Year 04 Month 01 Day
Last follow-up date
2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2021 Year 03 Month 22 Day
Last modified on
2021 Year 03 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049486

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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