UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043702 |
|---|---|
| Receipt number | 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 | 2024/09/23 12:54:55 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
Suicide Risk
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
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
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
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
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
nmitsui@med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University
Institute
Department
Personal name
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
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
https://rctportal.niph.go.jp/s/detail/um?trial_id=UMIN000043702
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
17
Results
Following the intervention, the study observed moderate to large improvements in self-esteem, self-compassion, hopelessness, depression, and suicide risk. The participants also reported reliable changes in clinical outcomes and positive perceptions of the program.
Results date posted
| 2024 | Year | 09 | Month | 23 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2024 | Year | 08 | Month | 31 | Day |
Baseline Characteristics
All participants were Japanese. Fourteen participants (21.4% female) completed the psychoeducation program. The mean age of the sample was 22.53 years (SD = 2.35), with ages ranging from 18 to 28 years. Among the participants, three (21.4%) had attempted suicide in the past.
Participant flow
A total of 17 participants consented to participate in the intervention, 14 completed post-treatment assessment, 10 completed the four-week follow-up assessment, and 8 completed the eight-week and twelve-week follow-up assessment.
Adverse events
Outcome measures
The paired-sample t-test indicated that self-compassion (g = 1.02 [0.56; 1.48]), depression (g = 0.62 [0.22; 1.03]), hopelessness (g = 0.49 [0.18; 0.79]), and suicide risk (g = 0.43 [0.06; 0.79]) significantly changed from baseline to post-intervention. At the four-week follow-up, we observed significant changes between baseline and one-month-follow-up for self-esteem and self-compassion, with a large effect size (g = 1.04 [0.39; 1.69]) and a moderate effect size (g = 0.53 [0.08; 0.98]) respectively. At the eight-week follow-up, improvements in self-esteem (g = 0.44 [0.05; 0.82]) and self-compassion (g = 1.00 [0.20; 1.80]) remained significant. Additionally, changes in hopelessness (g = 0.37 [0.09; 0.66]) and suicide risk (g = 0.64 [0.27; 1.01]) returned to be significant during this period. At the twelve-week follow-up, the paired-sample t-test demonstrated that only self-compassion (g = 1.22 [0.05; 2.38]), suicide risk (g = 0.68 [0.03; 1.33]), and depression (g = 0.96 [0.44; 1.48]) showed significant changes with moderate to large effect sizes.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2020 | Year | 10 | Month | 29 | Day |
Date of IRB
| 2021 | Year | 06 | Month | 16 | Day |
Anticipated trial start date
| 2021 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
| 2024 | Year | 04 | Month | 02 | Day |
Other
Other related information
Management information
Registered date
| 2021 | Year | 03 | Month | 22 | Day |
Last modified on
| 2024 | Year | 09 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049486
