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 |
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
日本語
Mind-REST Intervention
英語
Mind-REST Intervention
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
日本語
Mind-REST Intervention
英語
Mind-REST Intervention
北米/North America |
日本語
Suicidal thoughts and behaviors
英語
Suicidal thoughts and behaviors
精神神経科学/Psychiatry | 成人/Adult |
悪性腫瘍以外/Others
いいえ/NO
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.
その他/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.
探索的/Exploratory
その他/Others
第Ⅰ・Ⅱ相/Phase I,II
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
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
介入/Interventional
並行群間比較/Parallel
ランダム化/Randomized
個別/Individual
オープン/Open -no one is blinded
実薬・標準治療対照/Active
はい/YES
いいえ/NO
施設を考慮していない/Institution is not considered as adjustment factor.
いいえ/NO
知る必要がない/No need to know
2
治療・ケア/Treatment
行動・習慣/Behavior,custom |
日本語
Mind-REST Intervention
英語
Mind-REST Intervention
日本語
Sham-mindfulness control group
英語
Sham-mindfulness control group
日本語
英語
日本語
英語
日本語
英語
日本語
英語
日本語
英語
日本語
英語
日本語
英語
日本語
英語
18 | 歳/years-old | 以上/<= |
適用なし/Not applicable |
男女両方/Male and Female
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.
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.
80
日本語
名 | Ana |
ミドルネーム | |
姓 | Rabasco |
英語
名 | Ana |
ミドルネーム | |
姓 | Rabasco |
日本語
Fordham University
英語
Fordham University
日本語
Fordham University
英語
Fordham University
10458
日本語
441 East Fordham Rd., Bronx, NY
英語
441 East Fordham Rd., Bronx, NY
929-399-9124
arabasco1@fordham.edu
日本語
名 | Ana |
ミドルネーム | |
姓 | Rabasco |
英語
名 | Ana |
ミドルネーム | |
姓 | Rabasco |
日本語
Fordham University
英語
Fordham University
日本語
Fordham University
英語
Fordham University
10458
日本語
441 East Fordham Rd., Bronx, NY
英語
441 East Fordham Rd., Bronx, NY
929-399-9124
arabasco1@fordham.edu
日本語
その他
英語
Fordham University
日本語
Fordham University
日本語
Psychology Department
日本語
Ana Rabasco
英語
Ana Rabasco
日本語
その他
英語
Fordham University
日本語
Fordham University
日本語
海外/Outside Japan
日本語
英語
日本語
英語
日本語
英語
日本語
Fordham University
英語
Fordham University
日本語
441 East Fordham Rd., Bronx, NY 10458
英語
441 East Fordham Rd., Bronx, NY 10458
718-817-0876
irb@fordham.edu
いいえ/NO
日本語
英語
日本語
英語
2023 | 年 | 08 | 月 | 22 | 日 |
None
未公表/Unpublished
None
82
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).
2023 | 年 | 08 | 月 | 22 | 日 |
日本語
英語
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.
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.
日本語
None
英語
None
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
日本語
英語
日本語
英語
参加者募集終了‐試験継続中/No longer recruiting
2021 | 年 | 07 | 月 | 01 | 日 |
2021 | 年 | 07 | 月 | 01 | 日 |
2021 | 年 | 09 | 月 | 08 | 日 |
2021 | 年 | 12 | 月 | 20 | 日 |
2022 | 年 | 01 | 月 | 15 | 日 |
2022 | 年 | 01 | 月 | 15 | 日 |
日本語
英語
2023 | 年 | 08 | 月 | 22 | 日 |
2023 | 年 | 08 | 月 | 22 | 日 |
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
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