UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051967 |
|---|---|
| Receipt number | R000059312 |
| Scientific Title | Mindfulness for Reducing Everyday Suicidal Thoughts (Mind-REST): A Daily Mindfulness Intervention for Individuals at High Risk For Suicide |
| Date of disclosure of the study information | 2023/08/22 |
| Last modified on | 2023/08/22 02:25:01 |
* 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
Mindfulness for Reducing Everyday Suicidal Thoughts (Mind-REST): A Daily Mindfulness Intervention for Individuals at High Risk For Suicide
Acronym
Mind-REST Intervention
Scientific Title
Mindfulness for Reducing Everyday Suicidal Thoughts (Mind-REST): A Daily Mindfulness Intervention for Individuals at High Risk For Suicide
Scientific Title:Acronym
Mind-REST Intervention
Region
| North America |
Condition
Condition
Suicidal thoughts and behaviors
Classification by specialty
| Psychiatry | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
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.
Basic objectives2
Others
Basic objectives -Others
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.
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Phase I,II
Assessment
Primary outcomes
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
Key secondary outcomes
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
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Mind-REST Intervention
Interventions/Control_2
Sham-mindfulness control group
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
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.
Key exclusion criteria
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.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Ana |
| Middle name | |
| Last name | Rabasco |
Organization
Fordham University
Division name
Fordham University
Zip code
10458
Address
441 East Fordham Rd., Bronx, NY
TEL
929-399-9124
arabasco1@fordham.edu
Public contact
Name of contact person
| 1st name | Ana |
| Middle name | |
| Last name | Rabasco |
Organization
Fordham University
Division name
Fordham University
Zip code
10458
Address
441 East Fordham Rd., Bronx, NY
TEL
929-399-9124
Homepage URL
arabasco1@fordham.edu
Sponsor or person
Institute
Fordham University
Institute
Department
Personal name
Ana Rabasco
Funding Source
Organization
Fordham University
Organization
Division
Category of Funding Organization
Outside Japan
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Fordham University
Address
441 East Fordham Rd., Bronx, NY 10458
Tel
718-817-0876
irb@fordham.edu
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
| 2023 | Year | 08 | Month | 22 | Day |
Related information
URL releasing protocol
None
Publication of results
Unpublished
Result
URL related to results and publications
None
Number of participants that the trial has enrolled
82
Results
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).
Results date posted
| 2023 | Year | 08 | Month | 22 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
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.
Participant flow
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.
Adverse events
None
Outcome measures
See above
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2021 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 07 | Month | 01 | Day |
Anticipated trial start date
| 2021 | Year | 09 | Month | 08 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 20 | Day |
Date of closure to data entry
| 2022 | Year | 01 | Month | 15 | Day |
Date trial data considered complete
| 2022 | Year | 01 | Month | 15 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 08 | Month | 22 | Day |
Last modified on
| 2023 | Year | 08 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059312
