UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053950 |
|---|---|
| Receipt number | R000061579 |
| Scientific Title | Reducing Self-Stigma Among Individuals with History of Childhood Maltreatment: A Randomized Controlled Trial |
| Date of disclosure of the study information | 2024/03/24 |
| Last modified on | 2025/03/24 13:48:34 |
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Basic information
Public title
Research on critical attitudes toward oneself due to painful childhood experiences
Acronym
Childhood Self-Criticism Study
Scientific Title
Reducing Self-Stigma Among Individuals with History of Childhood Maltreatment: A Randomized Controlled Trial
Scientific Title:Acronym
Reducing Self-Stigma Among Individuals with History of Childhood Maltreatment: A Randomized Controlled Trial
Region
| Japan |
Condition
Condition
Adverse Childhood Experiences
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of the proposed study is twofold: (1) to evaluate the effectiveness of a brief video-based intervention in reducing self-stigma among individuals who experienced childhood abuse and/or maltreatment, and (2) to increase openness to seeking treatment.
Basic objectives2
Others
Basic objectives -Others
The current study will examine the efficacy of a brief video intervention in reducing self-stigma and increasing openness to treatment in those with a history of CM. The intervention will consist of a 2-minute video in which CM survivors (presented by female and male actors) share their childhood experiences and describe how they were able to deal with them and seek mental health care. Participants will then fill in several questionnaires measuring self-stigma-related
aspects, openness to seek help, and emotional engagement with the intervention.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Self-stigma questionnaire
Time points: immediately pre-intervention (baseline), immediately postintervention,
and at 30-day follow-up
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
The intervention will consist of a 2-minute video in which CM survivors (presented by female and male actors) share their childhood experiences and describe how they were able to deal with them and seek mental health care.
Interventions/Control_2
Watch a 2-minute video that does not include a narrative of inappropriate nurturing of your own childhood
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
| 36 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.Target number of patients
Target number of patients (overall): 400 [Target group: 200 patients, Control group: 200 patients
Rationale for setting the target number of patients
In a previous study conducted by Dr. Neria et al.8), changes in stigma were found between the intervention group and the control group after viewing videos in a survey of 270 subjects each.
2. Conditions of study subjects
Subjects
Age: 18 years old or older, under 36 years old
Place of residence: Japan
Language: Japanese language speakers
Childhood experiences: Experiences up to the age of 17 years old, which correspond to one or more of the following 7 items (Childhood Adversity Experiences)
1) A family member or someone who lived with you in the house physically abused you or another family member at least once.
2) One or more times a family member has sworn at you, criticized you, humiliated you, or threatened you
3) You had unwanted or inappropriate sexual experiences
4) You felt unloved or unsupported by your family or that your family did not care about or support each other
5) More than once you did not get enough to eat, had to wear dirty clothes, or your caregiver was too drunk or upset to take care of you
6) One of the family members had a mental illness or was a regular or problematic drug user
7) One of the family members was incarcerated in prison
Key exclusion criteria
None
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Misari |
| Middle name | |
| Last name | Oe |
Organization
kurume University
Division name
Department of Neuropsychiatry
Zip code
8300011
Address
Asahi-machi 67, Kurume
TEL
0942-31-7564
oe_misari@kurume-u.ac.jp
Public contact
Name of contact person
| 1st name | Misari |
| Middle name | |
| Last name | Oe |
Organization
Kurume University
Division name
Department of Neuropsychiatry
Zip code
8300011
Address
Asahi-machi 67, Kurume
TEL
0942-31-7564
Homepage URL
oe_misari@kurume-u.ac.jp
Sponsor or person
Institute
Kurume University
Institute
Department
Personal name
Funding Source
Organization
Kurume University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Clinical Research Center, Kurume University Hospital
Address
Asahi-machi, Kurume
Tel
0942-65-3749
i_rinri@kurume-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
| 2024 | Year | 03 | Month | 24 | 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
Completed
Date of protocol fixation
| 2024 | Year | 02 | Month | 02 | Day |
Date of IRB
| 2024 | Year | 01 | Month | 29 | Day |
Anticipated trial start date
| 2024 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 03 | Month | 23 | Day |
Last modified on
| 2025 | Year | 03 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061579
