UMIN-CTR 臨床試験登録情報の閲覧

UMIN試験ID UMIN000051967
受付番号 R000059312
科学的試験名 Mindfulness for Reducing Everyday Suicidal Thoughts (Mind-REST): A Daily Mindfulness Intervention for Individuals at High Risk For Suicide
一般公開日(本登録希望日) 2023/08/22
最終更新日 2023/08/22 02:25:01

※ 本ページ収載の情報は、臨床試験に関する情報公開を目的として、UMINが開設しているUMIN臨床試験登録システムに提供された臨床試験情報です。
※ 特定の医薬品や治療法等については、医療関係者や一般の方に向けて広告することは目的としていません。


基本情報/Basic information

一般向け試験名/Public title

日本語
Mindfulness for Reducing Everyday Suicidal Thoughts (Mind-REST): A Daily Mindfulness Intervention for Individuals at High Risk For Suicide


英語
Mindfulness for Reducing Everyday Suicidal Thoughts (Mind-REST): A Daily Mindfulness Intervention for Individuals at High Risk For Suicide

一般向け試験名略称/Acronym

日本語
Mind-REST Intervention


英語
Mind-REST Intervention

科学的試験名/Scientific Title

日本語
Mindfulness for Reducing Everyday Suicidal Thoughts (Mind-REST): A Daily Mindfulness Intervention for Individuals at High Risk For Suicide


英語
Mindfulness for Reducing Everyday Suicidal Thoughts (Mind-REST): A Daily Mindfulness Intervention for Individuals at High Risk For Suicide

科学的試験名略称/Scientific Title:Acronym

日本語
Mind-REST Intervention


英語
Mind-REST Intervention

試験実施地域/Region

北米/North America


対象疾患/Condition

対象疾患名/Condition

日本語
Suicidal thoughts and behaviors


英語
Suicidal thoughts and behaviors

疾患区分1/Classification by specialty

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/Objectives

目的1/Narrative objectives1

日本語
The first aim of this study was to investigate the feasibility and acceptability of a pilot randomized controlled trial (RCT) of a brief, daily mindfulness intervention aimed at reducing suicidal ideation and behaviors among individuals with recent suicidality, compared with a sham mindfulness control condition.


英語
The first aim of this study was to investigate the feasibility and acceptability of a pilot randomized controlled trial (RCT) of a brief, daily mindfulness intervention aimed at reducing suicidal ideation and behaviors among individuals with recent suicidality, compared with a sham mindfulness control condition.

目的2/Basic objectives2

その他/Others

目的2 -その他詳細/Basic objectives -Others

日本語
The second aim of this study was to examine the preliminary efficacy of the mindfulness intervention in comparison to the sham mindfulness control condition in decreasing suicidal ideation and behaviors.


英語
The second aim of this study was to examine the preliminary efficacy of the mindfulness intervention in comparison to the sham mindfulness control condition in decreasing suicidal ideation and behaviors.

試験の性質1/Trial characteristics_1

探索的/Exploratory

試験の性質2/Trial characteristics_2

その他/Others

試験のフェーズ/Developmental phase

第Ⅰ・Ⅱ相/Phase I,II


評価/Assessment

主要アウトカム評価項目/Primary outcomes

日本語
1) Feasibility: 1a) Study retention rates (overall study period), 1b) Study compliance rates (with mindfulness intervention, daily survey)
2) Acceptability: 2a) Select items from client satisfaction questionnaire at post-intervention, 2b) Mood change from before to after the mindfulness exercises


英語
1) Feasibility: 1a) Study retention rates (overall study period), 1b) Study compliance rates (with mindfulness intervention, daily survey)
2) Acceptability: 2a) Select items from client satisfaction questionnaire at post-intervention, 2b) Mood change from before to after the mindfulness exercises

副次アウトカム評価項目/Key secondary outcomes

日本語
1) Efficacy for suicidal ideation severity (as measured by the Beck Scale for Suicidal Ideation or BSS): Difference in suicidal ideation severity between intervention and control groups at post-intervention and one-month follow-up
2) Efficacy for suicidal behaviors (as measured by the Columbia Suicide Severity Rating Scale or C-SSRS): Difference in rate of suicidal behaviors between intervention and control groups at post-intervention and one-month follow-up


英語
1) Efficacy for suicidal ideation severity (as measured by the Beck Scale for Suicidal Ideation or BSS): Difference in suicidal ideation severity between intervention and control groups at post-intervention and one-month follow-up
2) Efficacy for suicidal behaviors (as measured by the Columbia Suicide Severity Rating Scale or C-SSRS): Difference in rate of suicidal behaviors between intervention and control groups at post-intervention and one-month follow-up


基本事項/Base

試験の種類/Study type

介入/Interventional


試験デザイン/Study design

基本デザイン/Basic design

並行群間比較/Parallel

ランダム化/Randomization

ランダム化/Randomized

ランダム化の単位/Randomization unit

個別/Individual

ブラインド化/Blinding

オープン/Open -no one is blinded

コントロール/Control

実薬・標準治療対照/Active

層別化/Stratification

はい/YES

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

いいえ/NO

割付コードを知る方法/Concealment

知る必要がない/No need to know


介入/Intervention

群数/No. of arms

2

介入の目的/Purpose of intervention

治療・ケア/Treatment

介入の種類/Type of intervention

行動・習慣/Behavior,custom

介入1/Interventions/Control_1

日本語
Mind-REST Intervention


英語
Mind-REST Intervention

介入2/Interventions/Control_2

日本語
Sham-mindfulness control group


英語
Sham-mindfulness control group

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


適格性/Eligibility

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
Inclusion criteria included being 18 years old or older, experiencing two or more suicidal thoughts in the past two weeks and/or any suicidal behavior in the past month, having access to a smartphone and regular data and/or Wi-Fi connection, and ability to speak and read English.


英語
Inclusion criteria included being 18 years old or older, experiencing two or more suicidal thoughts in the past two weeks and/or any suicidal behavior in the past month, having access to a smartphone and regular data and/or Wi-Fi connection, and ability to speak and read English.

除外基準/Key exclusion criteria

日本語
Exclusion criteria included regular mindfulness practice in the past three months (practicing mindfulness one or more times per month) and inability to provide informed consent.


英語
Exclusion criteria included regular mindfulness practice in the past three months (practicing mindfulness one or more times per month) and inability to provide informed consent.

目標参加者数/Target sample size

80


責任研究者/Research contact person

責任研究者/Name of lead principal investigator

日本語
Ana
ミドルネーム
Rabasco


英語
Ana
ミドルネーム
Rabasco

所属組織/Organization

日本語
Fordham University


英語
Fordham University

所属部署/Division name

日本語
Fordham University


英語
Fordham University

郵便番号/Zip code

10458

住所/Address

日本語
441 East Fordham Rd., Bronx, NY


英語
441 East Fordham Rd., Bronx, NY

電話/TEL

929-399-9124

Email/Email

arabasco1@fordham.edu


試験問い合わせ窓口/Public contact

試験問い合わせ窓口担当者/Name of contact person

日本語
Ana
ミドルネーム
Rabasco


英語
Ana
ミドルネーム
Rabasco

組織名/Organization

日本語
Fordham University


英語
Fordham University

部署名/Division name

日本語
Fordham University


英語
Fordham University

郵便番号/Zip code

10458

住所/Address

日本語
441 East Fordham Rd., Bronx, NY


英語
441 East Fordham Rd., Bronx, NY

電話/TEL

929-399-9124

試験のホームページURL/Homepage URL


Email/Email

arabasco1@fordham.edu


実施責任個人または組織/Sponsor or person

機関名/Institute

日本語
その他


英語
Fordham University

機関名/Institute
(機関選択不可の場合)

日本語
Fordham University


部署名/Department

日本語
Psychology Department


個人名/Personal name

日本語
Ana Rabasco


英語
Ana Rabasco


研究費提供組織/Funding Source

機関名/Organization

日本語
その他


英語
Fordham University

機関名/Organization
(機関選択不可の場合)

日本語
Fordham University


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


その他の関連組織/Other related organizations

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


IRB等連絡先(公開)/IRB Contact (For public release)

組織名/Organization

日本語
Fordham University


英語
Fordham University

住所/Address

日本語
441 East Fordham Rd., Bronx, NY 10458


英語
441 East Fordham Rd., Bronx, NY 10458

電話/Tel

718-817-0876

Email/Email

irb@fordham.edu


他機関から発行された試験ID/Secondary IDs

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/Institutions

試験実施施設名称/Institutions



その他の管理情報/Other administrative information

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

2023 08 22


関連情報/Related information

プロトコル掲載URL/URL releasing protocol

None

試験結果の公開状況/Publication of results

未公表/Unpublished


結果/Result

結果掲載URL/URL related to results and publications

None

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

82

主な結果/Results

日本語
Results indicated that the mindfulness intervention was feasible and acceptable to participants. However, the preliminary efficacy of the intervention was not supported (no significant difference in suicidal ideation or behaviors between control and intervention groups at post-intervention and follow-up).


英語
Results indicated that the mindfulness intervention was feasible and acceptable to participants. However, the preliminary efficacy of the intervention was not supported (no significant difference in suicidal ideation or behaviors between control and intervention groups at post-intervention and follow-up).

主な結果入力日/Results date posted

2023 08 22

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
Participants ranged in age from 18 to 72 years old, with an average age of 36.38 (SD = 13.12). The majority of the sample identified as women (74%, n = 61). Eighty-seven percent (n = 71) of the sample identified as white. Fifty-four participants (66%) reported that their sexual orientation was heterosexual.


英語
Participants ranged in age from 18 to 72 years old, with an average age of 36.38 (SD = 13.12). The majority of the sample identified as women (74%, n = 61). Eighty-seven percent (n = 71) of the sample identified as white. Fifty-four participants (66%) reported that their sexual orientation was heterosexual.

参加者の流れ/Participant flow

日本語
A total of 346 individuals were assessed for eligibility. Eighty-two participants completed the baseline survey and were randomized to either the intervention (n = 40) or control (n = 42) group. Thirty-five participants in the intervention group and 34 participants in the control group completed the post-intervention survey. Thirty-one participants in the intervention group and 33 participants in the control group completed the one-month follow-up survey.


英語
A total of 346 individuals were assessed for eligibility. Eighty-two participants completed the baseline survey and were randomized to either the intervention (n = 40) or control (n = 42) group. Thirty-five participants in the intervention group and 34 participants in the control group completed the post-intervention survey. Thirty-one participants in the intervention group and 33 participants in the control group completed the one-month follow-up survey.

有害事象/Adverse events

日本語
None


英語
None

評価項目/Outcome measures

日本語
Beck Scale for Suicidal Ideation (BSS; Beck & Steer, 1991)
Suicidal ideation severity at baseline, post-intervention, and follow-up was measured using the BSS, a 21-item self-report measure (Beck & Steer, 1991). The first 19 questions of the BSS are summed to provide a suicidal ideation severity score in the past week. Overall, the BSS has established internal reliability, test-retest reliability, and concurrent validity (Brown, 1999). In the current study, the internal consistency of the BSS suicidal ideation severity score was excellent at baseline (Cronbach’s alpha = .98), good at post-intervention (Cronbach’s alpha = .86), and excellent at one-month follow-up (Cronbach’s alpha = .90).

Columbia Suicide Severity Rating Scale (C-SSRS; Posner et al., 2011)
Suicidal behaviors over one’s lifetime (assessed at baseline) and over the course of the study period (assessed at post-intervention and follow-up) were measured using items from the C-SSRS (Posner et al., 2011). Suicidal behaviors included suicide attempts, interrupted attempts, aborted attempts, and preparatory behaviors (e.g., writing a suicide note, collecting pills). A suicidal behaviors composite variable was calculated for baseline, post-intervention, and one-month follow-up; it reflected the presence or absence of any suicidal behaviors. Although the original C-SSRS is a clinician administered measure, it has been adapted to self-report formats (e.g., DeVylder et al., 2015; Nunez et al., 2019). Research has shown that the self-report adaptations accurately classify and differentiate at-risk groups (Nunez et al., 2019) and that the self-report C-SSRS is positively associated with measures of depressive symptoms, suggesting convergent validity of the measure (DeVylder et al., 2015).


英語
See above

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/Progress

試験進捗状況/Recruitment status

参加者募集終了‐試験継続中/No longer recruiting

プロトコル確定日/Date of protocol fixation

2021 07 01

倫理委員会による承認日/Date of IRB

2021 07 01

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

2021 09 08

フォロー終了(予定)日/Last follow-up date

2021 12 20

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

2022 01 15

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

2022 01 15

解析終了(予定)日/Date analysis concluded



その他/Other

その他関連情報/Other related information

日本語


英語


管理情報/Management information

登録日時/Registered date

2023 08 22

最終更新日/Last modified on

2023 08 22



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=R000059312


英語
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059312


研究計画書
登録日時 ファイル名

研究症例データ仕様書
登録日時 ファイル名

研究症例データ
登録日時 ファイル名