Back to resultsA Brief Mindfulness-Based Intervention for Suicidal Ideation (MB-SI)
Primary Purpose
Suicidal Ideation, Psychiatric Disorder, Addiction
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Brief Mindfulness Based Intervention
Sponsored by
About this trial
This is an interventional treatment trial for Suicidal Ideation focused on measuring mindfulness, suicide related behavior, Veterans, Veterans' Affairs, suicidal ideation
Eligibility Criteria
Inclusion Criteria:
- Admitted with suicidal ideation and any active psychiatric or addictive disorder diagnosis.
Exclusion Criteria:
- Diagnosis of psychotic spectrum illness and current psychotic symptoms or significant cognitive impairment.
Sites / Locations
- VA Salt Lake City Health Care System
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Brief Mindfulness Based Intervention
Treatment as Usual
Arm Description
Some participants, as a result of random selection, will be asked to participate in four, 45-minute sessions that will occur on four separate days while on the Inpatient Psychiatric Unit (IPU). These four sessions are in addition to the standard IPU treatment and are experimental. These four sessions will include mindfulness meditation practice and education, creating a Crisis Response Plan, and a brief introduction into self-compassion. As stated above, practicing mindfulness means focusing attention on what is occurring in the present moment in a non-judgmental way. The focus may be on what one is seeing or hearing or physical sensations, such as touch, as well as thoughts and emotions. Meditation is just sitting quietly and practicing mindful awareness.
Participants will be asked to fill out several short paper and pencil tests to assess your response to the treatment (10 to 15 minutes) pre-intervention and immediately post-intervention while on the Inpatient Psychiatric Unit (IPU), as well as a follow-up phone call or mail one month after discharge from the IPU. All participants will receive the IPU's normal standard of care treatment (for study purposes this called treatment as usual).
Outcomes
Primary Outcome Measures
Measure P1: Change in Columbia Suicide Severity Rating Scale among the MB-SI + TAU cohort compared to the TAU only cohort
Determine if there is a significant difference in 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. Longitudinal generalized linear mixed models will be used for the primary analyses. We estimate a total of two time points (baseline and one month follow-up) for the primary outcome.
Secondary Outcome Measures
Measure S1: Number or category of patient and intervention characteristics
Demographic data extraction will include gender, age, race, ethnicity, religious preferences, service branch, service connection, percent of service connection, diagnosis of psychiatric disorders, substance abuse disorder (SUD) diagnosis, medical diagnosis, and medical diagnosis. In addition, the following factors will also be tracked: the group the participant has been placed in, admission date, consent date, the four intervention dates ( if participant is placed in the treatment group), post-intervention date, and one-month post-intervention date.
Measure S2: Change in psychiatric hospitalizations, emergency room visits for psychiatric illness, and emergency room visits
The change in psychiatric hospitalizations, emergency room visits for psychiatric illness, and emergency room visits, as measured by retrospective review of the electronic medical record, among the MB-SI + TAU cohort will be compared to the TAU only cohort.
Measure S3: Change in TMS among the MB-SI + TAU cohort compared to the TAU only cohort
Determine if there is a significant difference in state or trait mindfulness, as measured by the Toronto Mindfulness Scale (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.
Measure S4: Change in ERQ among the MB-SI + TAU cohort compared to the TAU only cohort
Determine if there is a significant difference in the Emotional Regulation Questionnaire (ERQ), among the MB-SI + TAU cohort compared to the TAU only cohort. ERQ is a 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.
Measure S5: Change in Five Facet Mindfulness among the MB-SI + TAU cohort compared to the TAU only cohort
Determine if there is a significant difference in Five Facet Mindfulness 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.
Full Information
NCT ID
NCT04099173
First Posted
July 16, 2019
Last Updated
May 9, 2023
Sponsor
VA Salt Lake City Health Care System
1. Study Identification
Unique Protocol Identification Number
NCT04099173
Brief Title
A Brief Mindfulness-Based Intervention for Suicidal Ideation
Acronym
MB-SI
Official Title
A Randomized Pilot Study of a Brief Mindfulness-Based Intervention for Suicidal Ideation
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
September 1, 2019 (Actual)
Primary Completion Date
January 5, 2023 (Actual)
Study Completion Date
January 5, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Salt Lake City Health Care System
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The primary aim of this study is to determine whether a Brief Mindfulness-Based Intervention for Suicidal Ideation (MB-SI) is feasible and safe to implement. The secondary aims are short and longer-term reduction in suicidal ideation (SI) and/or suicide-related behaviors (SRBs) as well as improvements in mindfulness and emotional regulation measures compared to Treatment as Usual (TAU).
Detailed Description
The study feasibility will be assessed through participant enrollment and retention numbers. The safety be monitored by the study personnel and include reporting any adverse effects. The intervention fidelity will be aided by standardizing the intervention and ensuring study personnel has the appropriate trainings. Participants will completed questionnaires assessing their SI and SRB as well as mindfulness and emotional regulation measures at three time points (preintervention, immediately postintervention, and 1-month postintervention) and their results will be compared between MB-SI and TAU groups. Additionally, the comparisons will also be conducted for the Emergency Department (ED) admissions, Inpatient Psychiatric Unit (IPU) admissions, and psychiatric ED admissions.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicidal Ideation, Psychiatric Disorder, Addiction
Keywords
mindfulness, suicide related behavior, Veterans, Veterans' Affairs, suicidal ideation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Brief Mindfulness Based Intervention
Arm Type
Experimental
Arm Description
Some participants, as a result of random selection, will be asked to participate in four, 45-minute sessions that will occur on four separate days while on the Inpatient Psychiatric Unit (IPU). These four sessions are in addition to the standard IPU treatment and are experimental. These four sessions will include mindfulness meditation practice and education, creating a Crisis Response Plan, and a brief introduction into self-compassion. As stated above, practicing mindfulness means focusing attention on what is occurring in the present moment in a non-judgmental way. The focus may be on what one is seeing or hearing or physical sensations, such as touch, as well as thoughts and emotions. Meditation is just sitting quietly and practicing mindful awareness.
Arm Title
Treatment as Usual
Arm Type
No Intervention
Arm Description
Participants will be asked to fill out several short paper and pencil tests to assess your response to the treatment (10 to 15 minutes) pre-intervention and immediately post-intervention while on the Inpatient Psychiatric Unit (IPU), as well as a follow-up phone call or mail one month after discharge from the IPU. All participants will receive the IPU's normal standard of care treatment (for study purposes this called treatment as usual).
Intervention Type
Behavioral
Intervention Name(s)
Brief Mindfulness Based Intervention
Other Intervention Name(s)
MB-SI+ TAU
Intervention Description
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.
Primary Outcome Measure Information:
Title
Measure P1: Change in Columbia Suicide Severity Rating Scale among the MB-SI + TAU cohort compared to the TAU only cohort
Description
Determine if there is a significant difference in 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. Longitudinal generalized linear mixed models will be used for the primary analyses. We estimate a total of two time points (baseline and one month follow-up) for the primary outcome.
Time Frame
pre-intervention and one month post-intervention
Secondary Outcome Measure Information:
Title
Measure S1: Number or category of patient and intervention characteristics
Description
Demographic data extraction will include gender, age, race, ethnicity, religious preferences, service branch, service connection, percent of service connection, diagnosis of psychiatric disorders, substance abuse disorder (SUD) diagnosis, medical diagnosis, and medical diagnosis. In addition, the following factors will also be tracked: the group the participant has been placed in, admission date, consent date, the four intervention dates ( if participant is placed in the treatment group), post-intervention date, and one-month post-intervention date.
Time Frame
throughout the study
Title
Measure S2: Change in psychiatric hospitalizations, emergency room visits for psychiatric illness, and emergency room visits
Description
The change in psychiatric hospitalizations, emergency room visits for psychiatric illness, and emergency room visits, as measured by retrospective review of the electronic medical record, among the MB-SI + TAU cohort will be compared to the TAU only cohort.
Time Frame
before the Inpatient Psychiatric Unit (IPU) admission, one-month before the IPU admission, and one-month after the discharge from the IPU
Title
Measure S3: Change in TMS among the MB-SI + TAU cohort compared to the TAU only cohort
Description
Determine if there is a significant difference in state or trait mindfulness, as measured by the Toronto Mindfulness Scale (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.
Time Frame
Pre-intervention, immediately post-intervention, and one month post-intervention
Title
Measure S4: Change in ERQ among the MB-SI + TAU cohort compared to the TAU only cohort
Description
Determine if there is a significant difference in the Emotional Regulation Questionnaire (ERQ), among the MB-SI + TAU cohort compared to the TAU only cohort. ERQ is a 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.
Time Frame
Pre-intervention and immediately post-intervention
Title
Measure S5: Change in Five Facet Mindfulness among the MB-SI + TAU cohort compared to the TAU only cohort
Description
Determine if there is a significant difference in Five Facet Mindfulness 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.
Time Frame
Pre-intervention, immediately post-intervention, and one month post-intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Admitted with suicidal ideation and any active psychiatric or addictive disorder diagnosis.
Exclusion Criteria:
Diagnosis of psychotic spectrum illness and current psychotic symptoms or significant cognitive impairment.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William R Marchand, MD, LFAPA
Organizational Affiliation
Salt Lake City Veterans' Administration Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Salt Lake City Health Care System
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84148
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
36208303
Citation
Herrmann TS, Nazarenko E, Marchand W, Day A, Merrill J, Neil M, Thatcher J, Garland E, Bryan C. Randomized Controlled Trial of a Brief Mindfulness-Based Intervention for Suicidal Ideation Among Veterans. Mil Med. 2022 Oct 8:usac291. doi: 10.1093/milmed/usac291. Online ahead of print.
Results Reference
derived
Learn more about this trial
A Brief Mindfulness-Based Intervention for Suicidal Ideation
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