Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Brief Mindfulness-Based Intervention for Suicidal Ideation (MB-SI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04099173
Recruitment Status : Recruiting
First Posted : September 23, 2019
Last Update Posted : December 11, 2019
Sponsor:
Information provided by (Responsible Party):
VA Salt Lake City Health Care System

Brief Summary:
The aim of this study is to determine whether a Brief Mindfulness-Based Intervention for Suicidal Ideation (MB-SI), consisting of four, 45 minute sessions (one session per day, provided over a range of 12 subsequent days) will result in short or longer-term reduction in suicidal ideation (SI) and/or suicide-related behaviors (SRBs) as well as improvements in secondary outcome measures compared to Treatment as Usual (TAU).

Condition or disease Intervention/treatment Phase
Suicidal Ideation Psychiatric Disorder Addiction, Substance Behavioral: Brief Mindfulness Based Intervention Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Pilot Study of a Brief Mindfulness-Based Intervention for Suicidal Ideation
Actual Study Start Date : September 1, 2019
Estimated Primary Completion Date : August 2022
Estimated Study Completion Date : August 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Suicide

Arm Intervention/treatment
Experimental: Brief Mindfulness Based Intervention Behavioral: Brief Mindfulness Based Intervention
This intervention will consist of four, 45 minute individual mindfulness training sessions (one session per day, over a range of 12 subsequent days) provided by a trained mindfulness facilitator.
Other Name: MB-SI

No Intervention: Treatment as Usual



Primary Outcome Measures :
  1. Measure P1: Number of participants with a significant change in the frequency and/or severity of suicidal-related behaviors [ Time Frame: Once within 24 business hours of enrollment, once at the day prior to discharge or on admission day 7 (or day 8 or 9 if day 7 is on a weekend), and once at one month post-intervention. ]
    Number of participants with a significant change in the frequency and/or severity of suicidal-related behaviors, as measured by the Columbia Suicide Severity Rating Scale, among the MB-SI + TAU cohort compared to the TAU only cohort. The total Columbia Suicide Severity Rating Scale score can range from 0 to 25, with higher values indicating greater intensity.


Secondary Outcome Measures :
  1. Measure S1: Number of participants with a significant change in psychiatric hospitalizations and emergency room visits for psychiatric illness [ Time Frame: One month post-intervention Psychiatric Hospitalizations and Emergency room visits for psychiatric illness ]
    Number of participants with a significant change in Psychiatric Hospitalizations and Emergency room visits, as measured by retrospective review of the electronic medical record, among the MB-SI + TAU cohort compared to the TAU only cohort for one month post-intervention

  2. Measure S2: Number of participants with a significant change in state or trait mindfulness, as measured by the Toronto Mindfulness Scale (TMS) [ Time Frame: Once within 24 business hours of enrollment to study and once at one month post-intervention. ]
    Number of participants with a significant change in state or trait mindfulness, as measured by the TMS, among the MB-SI + TAU cohort compared to the TAU only cohort. The TMS consists of 2 subscales: curiosity and decentering. Altogether, the TMS includes 13 statements rated on a scale from 0 = not at all, to 4 = very much. Higher values represent higher state of mindfulness.

  3. Measure S3: Number of participants with a significant change in affective state as measured by the Emotional Regulation Questionnaire [ Time Frame: Once within 24 business hours of enrollment to study and once on the day prior to discharge or on admission day 7 (or day 8 or 9 if day 7 is on a weekend). ]
    Number of participants with a significant change in affective state, as measured by the Emotional Regulation Questionnaire, among the MB-SI + TAU cohort compared to the TAU only cohort. 10-likert-type items designed to measure respondents' tendency to regulate emotions in two ways: cognitive reappraisal and expressive suppression. Scoring is kept continuous and each facet's scoring is kept separate. Higher scores indicate greater capacity for emotional regulation.

  4. Measure S4: Number of participants with a significant change in state or trait mindfulness, as measured by the Five Facet Mindfulness Scale [ Time Frame: Once within 24 hours of enrollment to study, once on the day prior to discharge or on admission day 7 (or day 8 or 9 if day 7 is on a weekend), and once at one month post-intervention. ]
    Number of participants with a significant change in state or trait mindfulness, as measured by the Five Facet Mindfulness Scale, among the MB-SI + TAU cohort compared to the TAU only cohort. Five Facet Mindfulness is a scale of 15 items, scores can range from 15 - 75, and higher scores indicate a greater capacity for mindfulness.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Currently experiencing suicidal ideation and any psychiatric or addictive disorder diagnosis.

Exclusion Criteria:

  • Diagnosis of psychotic spectrum illness and current psychotic symptoms or significant cognitive impairment.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04099173


Contacts
Layout table for location contacts
Contact: William R Marchand, MD, LFAPA 801-582-1565 william.marchand@va.gov

Locations
Layout table for location information
United States, Utah
VA Salt Lake City Health Care System Recruiting
Salt Lake City, Utah, United States, 84148
Contact: William R Marchand, MD    801-582-1565 ext 1847    William.Marchand@va.gov   
Sponsors and Collaborators
VA Salt Lake City Health Care System
Investigators
Layout table for investigator information
Principal Investigator: William R Marchand, MD, LFAPA Salt Lake City Veterans' Administration Medical Center
Layout table for additonal information
Responsible Party: VA Salt Lake City Health Care System
ClinicalTrials.gov Identifier: NCT04099173    
Other Study ID Numbers: IRB_00108786
First Posted: September 23, 2019    Key Record Dates
Last Update Posted: December 11, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by VA Salt Lake City Health Care System:
mindfulness
suicide related behavior
Veterans
Veterans' Affairs
Additional relevant MeSH terms:
Layout table for MeSH terms
Substance-Related Disorders
Mental Disorders
Problem Behavior
Suicidal Ideation
Behavioral Symptoms
Suicide
Self-Injurious Behavior
Chemically-Induced Disorders