Suicidal IdeationNCT03677882
A Brief Mind-Body Bridging Intervention for Suicidal Ideation
A study testing Mind Body Bridging Group Session in people with Suicidal Ideation and Mind Body Bridging, run by VA Salt Lake City Health Care System at 1 site in United States.
Trial summary
The aim of this study is to determine whether a Brief Mind-Body Bridging Intervention for Suicidal Ideation (MBB-SI) will result in short or longer-term reduction of psychological factors associated with suicidal ideation (SI) and/or suicide-related behaviors (SRB's) compared to Treatment as Usual (TAU). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Suicidal Ideation, Mind Body Bridging
- What is being tested?
- Mind Body Bridging Group Session
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Dec 2018to 31 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects will be Veterans aged 18-80 admitted to Substance Abuse Residential Rehabilitation Treatment Program (SARRTP) with addictive disorders and/or co-occurring psychiatric disorder with suicide risk factors.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
George E. Wahlen Department of Veterans Affairs Medical Center
Salt Lake City, Utah, 84148
About this study
Official title: A Randomized Pilot Study of a Brief Mind-Body Bridging Intervention for Suicidal Ideation
The aim of this study is to determine whether a Brief Mind-Body Bridging Intervention for Suicidal Ideation (MBB-SI) will result in short or longer-term reduction of psychological factors associated with suicidal ideation (SI) and/or suicide-related behaviors (SRB's) compared to Treatment as Usual (TAU).
- Conditions
- Suicidal Ideation, Mind Body Bridging
- Being tested
- Mind Body Bridging Group Session
- Keywords
- mind body bridging, mindfulness, suicidal ideation, suicide related behaviors
- Medical subject headings
- Suicidal Ideation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mind Body Bridging Group SessionBehavioural
Participants assigned to TAU + MBB will will receive treatment from the Suicide Prevention Team and the Mental Health Service, AND will be asked to participate in consisting of three to eight 60-minute sessions that will occur consecutively. Each group will be led by a trained MBB facilitator. Participants will receive a workbook at the beginning of the training that contains an explanation of all the major concepts involved in Mind Body Bridging. The workbook has homework assignments to be completed daily between group sessions.
| Study group | Role | What they receive |
|---|---|---|
| Treatment as Usual (TAU) | No intervention | Participants assigned to Treatment As Usual (TAU) will receive the normal standard of care treatment from the Suicide Prevention Team and the Mental Health Service which may include individual therapy, group therapy, and/or medication therapy, all as decided by the individual and his/her doctor. Treatment as usual also includes monitoring by the Suicide Prevention Team. |
| Treatment As Usual with Mind-Body Bridging (TAU + MBB) | Experimental | Participants assigned to TAU + MBB will will receive treatment from the Suicide Prevention Team and the Mental Health Service, AND will be asked to participate in consisting of three to eight 60-minute sessions that will occur consecutively. Each group will be led by a trained MBB facilitator. Participants will receive a workbook at the beginning of the training that contains an explanation of all the major concepts involved in Mind Body Bridging. The workbook has homework assignments to be completed daily between group sessions. Receives: Behavioral: Mind Body Bridging Group Session |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in frequency and/or intensity of suicidal ideation
Determine if there is a significant difference in the frequency and/or intensity of suicidal ideation, as measured by the Beck Scale for Suicide Ideation (BSS) among the MBB-SI + TAU cohort compared to the TAU. We will use the total BSS score, ranging from 0 to 38. Increased scores reflect greater suicide risk.
Measured: Weekly during the intervention, one-month post-intervention, three months post-intervention, six months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2018
- Study start18 Dec 2018
- Primary completion31 Jan 2023
- Study completion31 Jan 2023
Why it stopped: We experienced recruitment difficulties, and the focus of the department has changed.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Salt Lake City Health Care System
- Sponsor type
- US federal agency
- Collaborators
- Mind Body Bridging Charity
- Responsible party
- Sponsor
- Investigators
- William Marchand, MD, Principal investigator, VA Salt Lake City HCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03677882
- Sponsor's protocol ID
- VASaltLakeCity
- Status last verified
- Feb 2024
- First submitted
- 10 Sep 2018
- Last updated
- 13 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Pilot Study of a Brief Mind-Body Bridging Intervention for Suicidal Ideation
- ClinicalTrials.gov ID
- NCT03677882
- Acronym / sponsor ID
- VASaltLakeCity
- Conditions
- Suicidal Ideation, Mind Body Bridging
- Keywords
- mind body bridging, mindfulness, suicidal ideation, suicide related behaviors
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: We experienced recruitment difficulties, and the focus of the department has changed.
- Enrolment
- 13 participants (actual)
- Lead sponsor
- VA Salt Lake City Health Care SystemUS federal agency
- Collaborators
- Mind Body Bridging Charity
- Study start
- 18 Dec 2018 (actual)
- Primary completion
- 31 Jan 2023 (actual)
- Study completion
- 31 Jan 2023 (actual)
- First posted
- 19 Sep 2018 (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 aim of this study is to determine whether a Brief Mind-Body Bridging Intervention for Suicidal Ideation (MBB-SI) will result in short or longer-term reduction of psychological factors associated with suicidal ideation (SI) and/or suicide-related behaviors (SRB's) compared to Treatment as Usual (TAU).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment as Usual (TAU) | No intervention | –Participants assigned to Treatment As Usual (TAU) will receive the normal standard of care treatment from the Suicide Prevention Team and the Mental Health Service which may include individual therapy, group therapy, and/or medication therapy, all as decided by the individual and his/her doctor. Treatment as usual also includes monitoring by the Suicide Prevention Team. |
| Treatment As Usual with Mind-Body Bridging (TAU + MBB) | Experimental | Behavioral: Mind Body Bridging Group SessionParticipants assigned to TAU + MBB will will receive treatment from the Suicide Prevention Team and the Mental Health Service, AND will be asked to participate in consisting of three to eight 60-minute sessions that will occur consecutively. Each group will be led by a trained MBB facilitator. Participants will receive a workbook at the beginning of the training that contains an explanation of all the major concepts involved in Mind Body Bridging. The workbook has homework assignments to be completed daily between group sessions. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subjects will be Veterans aged 18-80 admitted to Substance Abuse Residential Rehabilitation Treatment Program (SARRTP) with addictive disorders and/or co-occurring psychiatric disorder with suicide risk factors.
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Mind Body Bridging Group SessionParticipants assigned to TAU + MBB will will receive treatment from the Suicide Prevention Team and the Mental Health Service, AND will be asked to participate in consisting of three to eight 60-minute sessions that will occur consecutively. Each group will be led by a trained MBB facilitator. Participants will receive a workbook at the beginning of the training that contains an explanation of all the major concepts involved in Mind Body Bridging. The workbook has homework assignments to be completed daily between group sessions. | Behavioural | Treatment As Usual with Mind-Body Bridging (TAU + MBB) |
Primary outcome
Change in frequency and/or intensity of suicidal ideation
Time frame: Weekly during the intervention, one-month post-intervention, three months post-intervention, six months post-intervention
Determine if there is a significant difference in the frequency and/or intensity of suicidal ideation, as measured by the Beck Scale for Suicide Ideation (BSS) among the MBB-SI + TAU cohort compared to the TAU. We will use the total BSS score, ranging from 0 to 38. Increased scores reflect greater suicide risk.
Results and safety
The study was stopped early (reason given: We experienced recruitment difficulties, and the focus of the department has changed.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2024.
- Individual participant dataSharing planned: No
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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 Marchand, MD principal investigator
VA Salt Lake City HCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mind Body Bridging Group Session in people with Suicidal Ideation and Mind Body Bridging, 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: stopped early, as of the sponsor's last update on 13 Feb 2024. 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 was stopped early (reason given: We experienced recruitment difficulties, and the focus of the department has changed.). Results are not available in the source record.
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?
Change in frequency and/or intensity of suicidal ideation (time frame: Weekly during the intervention, one-month post-intervention, three months post-intervention, six months post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Feb 2024.