UMIN-CTR 臨床試験登録情報の閲覧

一般向け試験名/Public title

日本語

英語
Using a Brief Self-Affirmation Intervention to Increase College Students' Intentions to Reduce Internet Use

一般向け試験名略称/Acronym

日本語

英語
a Brief Self-Affirmation Intervention to Increase College Students' Intentions to Reduce Internet Use

科学的試験名/Scientific Title

日本語

英語
Evaluating a Brief Self-Affirmation Intervention to Increase College Students' Intentions to Reduce Internet Use: A Randomized Controlled Trial

科学的試験名略称/Scientific Title:Acronym

日本語

英語
ABSI-IRIU-RCT

試験実施地域/Region

アジア（日本以外）/Asia(except Japan)

対象疾患名/Condition

日本語

英語
Smartphone overuse or dependence

疾患区分1/Classification by specialty

心療内科学/Psychosomatic Internal Medicine	精神神経科学/Psychiatry
成人/Adult

疾患区分2/Classification by malignancy

悪性腫瘍以外/Others

ゲノム情報の取扱い/Genomic information

いいえ/NO

目的1/Narrative objectives1

日本語

英語
This study is the first to evaluate the efficacy of a brief, digital self-affirmation intervention on message acceptance and behavioral intention to reduce Internet use among a large sample of Chinese college students, while exploring the moderating roles of demographics, risk status, and behavioral characteristics.

目的2/Basic objectives2

安全性/Safety

目的2 -その他詳細/Basic objectives -Others

日本語

英語

試験の性質1/Trial characteristics_1

試験の性質2/Trial characteristics_2

試験のフェーズ/Developmental phase

主要アウトカム評価項目/Primary outcomes

日本語

英語
Psychological questionnaires will be used to measure the primary outcomes, which consist of two main results.

Intention for reducing Internet Use: The first outcome will be assessed using three widely used items in social psychology and behavioral interventions: "I intend to reduce Internet use," "I will reduce my Internet use," and "How likely are you to reduce your Internet use?"

Message acceptance
After experimental tasks and health risk information, message acceptance was measured using a 3-item scale, similar to previous SAI studies. Participants rated the extent to which they perceived the health-risk information as "influential", "convincing", and "providing a good reason to prevent Internet addiction" on a 9-point Likert scale.

副次アウトカム評価項目/Key secondary outcomes

日本語

英語
Self-control. Self-control was measured using the validated Chinese version of Brief Self-Control Scale (Fung et al., 2020; Morean et al., 2014). Sample items include "I am good at resisting temptation."
Cognitive emotional regulation. Emotional regulation approaches, including self-blame, rumination, and catastrophizing, were measured using relevant subscales of the Cognitive Emotion Regulation Questionnaire-Short (CERQ-Short) (Garnefski & Kraaij, 2006). The Chinese version of CERQ has demonstrated satisfactory psychometric properties in undergraduate students (Zhu et al., 2008).
Self-efficacy in reducing Internet use. Corroborating prior research (Harren et al., 2021), a single item was used to assess participants' confidence in their ability to reduce Internet use: "If you wanted to, you are confident you could reduce your Internet use". Responses were rated on a 7-point Likert-type scale ranging from 1 (strongly disagree) to 7 (strongly agree), with higher scores denoting stronger self-efficacy.

試験の種類/Study type

介入/Interventional

基本デザイン/Basic design

要因デザイン/Factorial

ランダム化/Randomization

ランダム化/Randomized

ランダム化の単位/Randomization unit

集団/Cluster

ブラインド化/Blinding

二重盲検/Double blind -all involved are blinded

コントロール/Control

実薬・標準治療対照/Active

層別化/Stratification

いいえ/NO

動的割付/Dynamic allocation

いいえ/NO

試験実施施設の考慮/Institution consideration

施設を考慮していない/Institution is not considered as adjustment factor.

ブロック化/Blocking

はい/YES

割付コードを知る方法/Concealment

知る必要がない/No need to know

群数/No. of arms

2

介入の目的/Purpose of intervention

教育・カウンセリング・トレーニング/Educational,Counseling,Training

介入の種類/Type of intervention

行動・習慣/Behavior,custom

介入1/Interventions/Control_1

日本語

英語
Participants initially completed baseline assessments of demographic characteristics, risk perception, and behavioral variables related to Internet addiction.
Participants in the SAI group completed the Character Strength Questionnaire, which functioned as a mindset manipulation by directing attention to their personal strengths rather than measuring them. Participants were presented with the following prompt: "Please choose one option in response to each statement, if you are not sure choose the response that most closely reflects your thoughts. All of the questions reflect statements that many people would find desirable, but we want you to answer only in terms of whether the statement describes what you are like. Please be as honest and accurate as possible." They rated the extent to which 32 positive traits or characteristics apply to them (e.g., "I always get things done" and "I value my ability to think critically") on a 5-point Likert scale ranging from 1 (very much unlike me) to 5 (very much like me). These items were developed to encompass a broad spectrum of values and personal strengths.
Immediately post-task, all participants completed a 4-item manipulation check (e.g., "The activity made me think of positive aspects of myself, think of core values of myself, focus on what I am good at, realize what I value") rated on a 5-point Likert scale, with higher scores indicating greater self-affirmation.

介入2/Interventions/Control_2

日本語

英語
Participants initially completed baseline assessments of demographic characteristics, risk perception, and behavioral variables related to Internet addiction.
Participants in the control condition completed a closely time- and attention-matched task, rating the same set of items, but about a celebrity. As this study represents the first application of this tool within an Eastern cultural context, the original Western celebrity reference was adapted to a comparable Chinese celebrity (both are athletes), preserving the methodological integrity while ensuring cultural relevance.
Immediately post-task, all participants completed a 4-item manipulation check (e.g., "The activity made me think of positive aspects of myself, think of core values of myself, focus on what I am good at, realize what I value") rated on a 5-point Likert scale, with higher scores indicating greater self-affirmation.

介入3/Interventions/Control_3

日本語

英語

介入4/Interventions/Control_4

日本語

英語

介入5/Interventions/Control_5

日本語

英語

介入6/Interventions/Control_6

日本語

英語

介入7/Interventions/Control_7

日本語

英語

介入8/Interventions/Control_8

日本語

英語

介入9/Interventions/Control_9

日本語

英語

介入10/Interventions/Control_10

日本語

英語

年齢（下限）/Age-lower limit

18

歳/years-old

以上/<=

年齢（上限）/Age-upper limit

適用なし/Not applicable

性別/Gender

男女両方/Male and Female

選択基準/Key inclusion criteria

日本語

英語
1. aged >= 18 years;
2. current enrollment as a college student at a public university in Xi'an, Shanxi Province, China;
3. giving consent for participation. Participants were recruited through convenience and snowball sampling.

除外基準/Key exclusion criteria

日本語

英語
1:presence or history of neurologicalor neurodegenerative disorder
2:sensory impairments (e.g., vision or hearing problems) that preclude assessments
3:having a diagnosis of intellectual disability (IQ<70) or a pervasive developmental disorder (e.g., autism spectrum disorder)
4:having a current diagnosis of substance use disorder (excluding Cannabis and Tobacco in the past months).

目標参加者数/Target sample size

400

責任研究者/Name of lead principal investigator

日本語

名
ミドルネーム
姓

英語

名	Rui
ミドルネーム
姓	She

所属組織/Organization

日本語

英語
The Hong Kong Polytechnic University

所属部署/Division name

日本語

英語
Department of Rehabilitation Sciences

郵便番号/Zip code

999077

住所/Address

日本語

英語
The Hong Kong Polytechnic University Hung Hom, Kowloon Hong Kong SAR, China

電話/TEL

8613027936690

Email/Email

sherry-rui.she@polyu.edu.hk

試験問い合わせ窓口担当者/Name of contact person

日本語

名
ミドルネーム
姓

英語

名	Rui
ミドルネーム
姓	She

組織名/Organization

日本語

英語
The Hong Kong Polytechnic University

部署名/Division name

日本語

英語
Department of Rehabilitation Sciences

郵便番号/Zip code

999077

住所/Address

日本語

英語
The Hong Kong Polytechnic University Hung Hom, Kowloon Hong Kong SAR, China

電話/TEL

8613027936690

試験のホームページURL/Homepage URL

Email/Email

sherry-rui.she@polyu.edu.hk

機関名/Institute

日本語
その他

英語
The Hong Kong Polytechnic University

機関名/Institute
（機関選択不可の場合）

日本語

部署名/Department

日本語

個人名/Personal name

日本語

英語

機関名/Organization

日本語
その他

英語
The study is supported by the Start-up Fund in the Hong Kong Polytechnic University

機関名/Organization
（機関選択不可の場合）

日本語

組織名/Division

日本語

組織の区分/Category of Funding Organization

海外/Outside Japan

研究費拠出国/Nationality of Funding Organization

日本語

英語

共同実施組織/Co-sponsor

日本語

英語

その他の研究費提供組織/Name of secondary funder(s)

日本語

英語

組織名/Organization

日本語

英語
The Hong Kong Polytechnic University

住所/Address

日本語

英語
The Hong Kong Polytechnic University Hung Hom, Kowloon Hong Kong SAR, China

電話/Tel

(852) 3400-3635

Email/Email

RS.EthicsAdmin@polyu.edu.hk

他機関から発行された試験ID/Secondary IDs

いいえ/NO

試験ID1/Study ID_1

ID発行機関1/Org. issuing International ID_1

日本語

英語

試験ID2/Study ID_2

ID発行機関2/Org. issuing International ID_2

日本語

英語

治験届/IND to MHLW

試験実施施設名称/Institutions

一般公開日（本登録希望日）/Date of disclosure of the study information

2026

年

01

月

20

日

プロトコル掲載URL/URL releasing protocol

試験結果の公開状況/Publication of results

未公表/Unpublished

結果掲載URL/URL related to results and publications

組み入れ参加者数/Number of participants that the trial has enrolled

354

主な結果/Results

日本語

英語

主な結果入力日/Results date posted

結果掲載遅延/Results Delayed

結果遅延理由/Results Delay Reason

日本語

英語

最初の試験結果の出版日/Date of the first journal publication of results

参加者背景/Baseline Characteristics

日本語

英語

参加者の流れ/Participant flow

日本語

英語

有害事象/Adverse events

日本語

英語

評価項目/Outcome measures

日本語

英語

個別症例データ共有計画/Plan to share IPD

日本語

英語

個別症例データ共有計画の詳細/IPD sharing Plan description

日本語

英語

試験進捗状況/Recruitment status

試験終了/Completed

プロトコル確定日/Date of protocol fixation

2023

年

01

月

19

日

倫理委員会による承認日/Date of IRB

2023

年

01

月

19

日

登録・組入れ開始（予定）日/Anticipated trial start date

2023

年

02

月

01

日

フォロー終了(予定)日/Last follow-up date

2025

年

12

月

31

日

入力終了(予定)日/Date of closure to data entry

2025

年

12

月

31

日

データ固定（予定）日/Date trial data considered complete

2025

年

12

月

31

日

解析終了(予定)日/Date analysis concluded

2025

年

12

月

31

日

その他関連情報/Other related information

日本語

英語

登録日時/Registered date

2026

年

01

月

17

日

最終更新日/Last modified on

2026

年

01

月

17

日

閲覧ページへのリンク/Link to view the page

日本語
https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000069072

英語
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069072