Suicidal IdeationMB-SINCT04099173
A Brief Mindfulness-Based Intervention for Suicidal Ideation
A study testing Brief Mindfulness Based Intervention in people with Suicidal Ideation and Psychiatric Disorder, run by VA Salt Lake City Health Care System at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Suicidal Ideation, Psychiatric Disorder, Addiction
- What is being tested?
- Brief Mindfulness Based Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2019to 5 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Admitted with suicidal ideation and any active psychiatric or addictive disorder diagnosis.
Who cannot join
- Diagnosis of psychotic spectrum illness and current psychotic symptoms or significant cognitive impairment.
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Salt Lake City Health Care System
Salt Lake City, Utah, 84148
About this study
Official title: A Randomized Pilot Study of a Brief Mindfulness-Based Intervention for Suicidal Ideation
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).
Read the 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.
- Conditions
- Suicidal Ideation, Psychiatric Disorder, Addiction
- Being tested
- Brief Mindfulness Based Intervention
- Keywords
- mindfulness, suicide related behavior, Veterans, Veterans' Affairs, suicidal ideation
- Medical subject headings
- Suicidal Ideation, Mental Disorders, Behavior, Addictive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief Mindfulness Based InterventionBehavioural
Also called MB-SI+ TAU
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.
| Study group | Role | What they receive |
|---|---|---|
| Brief Mindfulness Based Intervention | Experimental | 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. Receives: Behavioral: Brief Mindfulness Based Intervention |
| Treatment as Usual | No intervention | 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: pre-intervention and one month post-intervention
Secondary outcomes (5)
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.
Measured: throughout the study
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.
Measured: before the Inpatient Psychiatric Unit (IPU) admission, one-month before the IPU admission, and one-month after the discharge from the IPU
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.
Measured: Pre-intervention, immediately post-intervention, and one month post-intervention
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.
Measured: Pre-intervention and immediately post-intervention
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.
Measured: Pre-intervention, immediately post-intervention, and one month post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2019
- Study start1 Sep 2019
- Primary completion5 Jan 2023
- Study completion5 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Suicidal IdeationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Salt Lake City Health Care System
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- William R Marchand, MD, LFAPA, Principal investigator, Salt Lake City Veterans' Administration Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04099173
- Sponsor's protocol ID
- IRB_00108786
- Acronym
- MB-SI
- Status last verified
- May 2023
- First submitted
- 16 Jul 2019
- Last updated
- 11 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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. 2024 Feb 27;189(3-4):732-741. doi: 10.1093/milmed/usac291.
PubMed 36208303
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Pilot Study of a Brief Mindfulness-Based Intervention for Suicidal Ideation
- ClinicalTrials.gov ID
- NCT04099173
- Acronym / sponsor ID
- MB-SI / IRB_00108786
- Conditions
- Suicidal Ideation, Psychiatric Disorder, Addiction
- Keywords
- mindfulness, suicide related behavior, Veterans, Veterans' Affairs, suicidal ideation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- VA Salt Lake City Health Care SystemUS federal agency
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 5 Jan 2023 (actual)
- Study completion
- 5 Jan 2023 (actual)
- First posted
- 23 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Brief Mindfulness Based Intervention | Experimental | Behavioral: Brief Mindfulness Based InterventionSome 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. |
| Treatment as Usual | No intervention | –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). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Admitted with suicidal ideation and any active psychiatric or addictive disorder diagnosis.
Key exclusion criteria (1 listed)
- Diagnosis of psychotic spectrum illness and current psychotic symptoms or significant cognitive impairment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brief Mindfulness Based InterventionAlso: MB-SI+ TAUThis 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. | Behavioural | Brief Mindfulness Based Intervention |
Primary outcome
Measure P1: Change in Columbia Suicide Severity Rating Scale among the MB-SI + TAU cohort compared to the TAU only cohort
Time frame: pre-intervention and one month post-intervention
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.
5 secondary outcomes
Measure S1: Number or category of patient and intervention characteristics
Time frame: throughout the study
Measure S2: Change in psychiatric hospitalizations, emergency room visits for psychiatric illness, and emergency room visits
Time frame: before the Inpatient Psychiatric Unit (IPU) admission, one-month before the IPU admission, and one-month after the discharge from the IPU
Measure S3: Change in TMS among the MB-SI + TAU cohort compared to the TAU only cohort
Time frame: Pre-intervention, immediately post-intervention, and one month post-intervention
Measure S4: Change in ERQ among the MB-SI + TAU cohort compared to the TAU only cohort
Time frame: Pre-intervention and immediately post-intervention
Measure S5: Change in Five Facet Mindfulness among the MB-SI + TAU cohort compared to the TAU only cohort
Time frame: Pre-intervention, immediately post-intervention, and one month post-intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2023.
- Derived from this study: PubMed 36208303Herrmann 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. 2024 Feb 27;189(3-4):732-741. doi: 10.1093/milmed/usac291.
- Individual participant dataSharing planned: No
Related trials for Suicidal Ideation
Not yet recruiting
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William R Marchand, MD, LFAPA principal investigator
Salt Lake City Veterans' Administration Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief Mindfulness Based Intervention in people with Suicidal Ideation and Psychiatric Disorder, run by VA Salt Lake City Health Care System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure P1: Change in Columbia Suicide Severity Rating Scale among the MB-SI + TAU cohort compared to the TAU only cohort (time frame: pre-intervention and one month post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04099173, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2023.