Suicide, AttemptedMI-SINCT05256940
Motivational Interviewing to Address Suicidal Ideation for Veterans at High Risk for Suicide
A study testing Motivational Interviewing to Address Suicidal Ideation- Revised (MI-SI-R) in people with Suicide, Attempted and Suicidal Ideation, run by VA Office of Research and Development at 3 sites in United States.
Trial summary
The purpose of this project is to conduct a randomized control trial with 470 Veterans to examine the impact of a revised version of Motivational Interviewing to Address Suicidal Ideation (MI-SI-R) on risk for suicide attempts and suicidal ideation when compared to high quality usual care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Suicide, Attempted, Suicidal Ideation
- What is being tested?
- Motivational Interviewing to Address Suicidal Ideation- Revised (MI-SI-R)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 368 participants
- Where
- 3 sitesUnited States
- Study dates
- 30 Nov 2022to 29 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Veteran status
- admitted to an inpatient unit, referred by a suicide prevention coordinator, or identified as high-risk via data extraction
- English speaking and reading
- ability to understand the study and provide informed consent
- high-risk status confirmed by suicide attempt within a month on the Columbia- Suicide Severity Rating Scale or a score > 5 on the Scale for Suicidal Ideation
Who cannot join
- current psychosis
- active mania
- dementia
- impaired decision making capacity
- institutionalization due to hospitalization in a non-VA facility, jail, or prison
Trial locations and contacts
3 sites in 1 country.
United States3 sites
VA Finger Lakes Healthcare System, Canandaigua, NY
Canandaigua, New York, 14424-1159
Ralph H. Johnson VA Medical Center, Charleston, SC
Charleston, South Carolina, 29401-5703
VA Portland Health Care System, Portland, OR
Portland, Oregon, 97207-2964
About this study
Official title: Motivational Interviewing to Address Suicidal Ideation: A Randomized Controlled Trial With Suicidal Veterans
The purpose of this project is to conduct a randomized control trial with 470 Veterans to examine the impact of a revised version of Motivational Interviewing to Address Suicidal Ideation (MI-SI-R) on risk for suicide attempts and suicidal ideation when compared to high quality usual care.
Read the detailed description
Research suggests that treatments to reduce suicidal behavior may need to focus on both the motivation to live and the motivation to die to obtain optimal effects. The PI developed a revised version of Motivational Interviewing to Address Suicidal Ideation (MI-SI-R) to help Veterans resolve ambivalence about living by increasing the motivation to live, that consists of three sessions delivered in-person, virtually, or by telephone. Enhanced usual care (EUC) for high-risk Veterans includes safety plans administered or reviewed by research therapists, care coordination, and access to a 24-hour crisis hotline. In a preliminary randomized controlled trial (RCT) in psychiatrically hospitalized Veterans, MI-SI-R plus EUC was associated with 50% fewer suicide attempts and 41% lower likelihood of suicidal ideation compared to EUC alone. The investigators are proposing an RCT comparing MI-SI-R plus EUC (MI-SI-R+EUC) to EUC alone in a sample of 470 high-risk Veterans with recent suicidal crises from three VHA Medical Centers, with "high-risk" defined as a suicide attempt within a month or suicidal ideation > 5 on the Beck Scale for Suicidal Ideation. Half (n = 235) will be randomized to MI-SI-R+EUC (three sessions in-person, via Video Connect, or telephone) and the remaining participants (n = 235) will receive EUC alone. All participants will be asked to complete telephone follow-up assessments at 1, 3, 6, and 12-months after randomization. This will allow the investigators to determine the efficacy of MI-SI-R+EUC in reducing risk for suicide attempts (Aim 1) and reducing overall suicidal ideation (Aim 2) when compared to EUC alone.
- Conditions
- Suicide, Attempted, Suicidal Ideation
- Being tested
- Motivational Interviewing to Address Suicidal Ideation- Revised (MI-SI-R), Enhanced usual care (EUC)
- Keywords
- veterans, motivational interviewing
- Medical subject headings
- Suicide, Attempted, Suicidal Ideation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational Interviewing to Address Suicidal Ideation- Revised (MI-SI-R)Behavioural
Motivational Interviewing to Address Suicidal Ideation (MI-SI-R) was developed to help Veterans resolve ambivalence about living by increasing the motivation to live, that is delivered in three sessions in person, virtually, or by telephone.
Enhanced usual care (EUC)Other
Enhanced usual care (EUC) includes safety plans administered or reviewed by research therapists, care coordination, and access to a 24-hour crisis hotline.
| Study group | Role | What they receive |
|---|---|---|
| Motivational Interviewing to Address Suicidal Ideation- Revised (MI-SI-R) | Experimental | Motivational Interviewing to Address Suicidal Ideation (MI-SI-R) was developed to help Veterans resolve ambivalence about living by increasing the motivation to live, and is delivered in three sessions in person, virtually, or by telephone. Receives: Behavioral: Motivational Interviewing to Address Suicidal Ideation- Revised (MI-SI-R); Other: Enhanced usual care (EUC) |
| Enhanced usual care (EUC) | Active comparator | Enhanced usual care (EUC) includes safety plans administered or reviewed by research therapists, care coordination, and access to a 24-hour crisis hotline. Receives: Other: Enhanced usual care (EUC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Columbia-Suicide Severity Rating Scale
The first primary outcome is the presence (vs. absence) of non-fatal suicide attempts as reported on the Columbia-Suicide Severity Rating Scale.
Measured: 12-months
Beck Scale for Suicidal Ideation
The second primary outcome is suicidal ideation as reported on the Beck Scale for Suicidal Ideation, which has a range from 0-38, with higher scores indicating more severe suicidal ideation.
Measured: 12-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2022
- Study start30 Nov 2022
- Primary completion29 Jun 2027 (estimated)
- Study completion29 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Suicide, AttemptedStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- 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
- Model description
- Motivational Interviewing to Address Suicidal Ideation (MI-SI-R) was developed to help participants at high-risk for suicide resolve their ambivalence about living by increasing their motivation to live, and is delivered in three sessions in-person, virtually, or by telephone.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 368 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Collaborators
- Syracuse VA Medical Center, Portland VA Medical Center, Ralph H. Johnson VA Medical Center
- Responsible party
- Sponsor
- Investigators
- Peter C. Britton, PhD MS, Principal investigator, VA Finger Lakes Healthcare System, Canandaigua, NY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05256940
- Sponsor's protocol ID
- MHBC-001-21S
- Other IDs
- I01CX002359
- Acronym
- MI-SI
- Status last verified
- Oct 2026
- First submitted
- 16 Feb 2022
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Members of the scientific community who would like a copy of limited data sets (i.e., data sets underlying any publication) from this study can request a copy by e-mailing the PI at Peter.Britton@va.gov. They should state their reason for requesting the data, their plans for analyzing the data, and agree not to attempt to re-identify participants. Limited data sets will be encrypted uploaded to a protected share-point; and the password will be sent to the requestor via a separate e-mail.
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Motivational Interviewing to Address Suicidal Ideation: A Randomized Controlled Trial With Suicidal Veterans
- ClinicalTrials.gov ID
- NCT05256940
- Acronym / sponsor ID
- MI-SI / MHBC-001-21S
- Conditions
- Suicide, Attempted, Suicidal Ideation
- Keywords
- veterans, motivational interviewing
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 368 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Collaborators
- Syracuse VA Medical Center, Portland VA Medical Center, Ralph H. Johnson VA Medical Center
- Study start
- 30 Nov 2022 (actual)
- Primary completion
- 29 Jun 2027 (estimated)
- Study completion
- 29 Jun 2027 (estimated)
- First posted
- 25 Feb 2022 (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 purpose of this project is to conduct a randomized control trial with 470 Veterans to examine the impact of a revised version of Motivational Interviewing to Address Suicidal Ideation (MI-SI-R) on risk for suicide attempts and suicidal ideation when compared to high quality usual care.
Detailed description
Research suggests that treatments to reduce suicidal behavior may need to focus on both the motivation to live and the motivation to die to obtain optimal effects. The PI developed a revised version of Motivational Interviewing to Address Suicidal Ideation (MI-SI-R) to help Veterans resolve ambivalence about living by increasing the motivation to live, that consists of three sessions delivered in-person, virtually, or by telephone. Enhanced usual care (EUC) for high-risk Veterans includes safety plans administered or reviewed by research therapists, care coordination, and access to a 24-hour crisis hotline. In a preliminary randomized controlled trial (RCT) in psychiatrically hospitalized Veterans, MI-SI-R plus EUC was associated with 50% fewer suicide attempts and 41% lower likelihood of suicidal ideation compared to EUC alone. The investigators are proposing an RCT comparing MI-SI-R plus EUC (MI-SI-R+EUC) to EUC alone in a sample of 470 high-risk Veterans with recent suicidal crises from three VHA Medical Centers, with "high-risk" defined as a suicide attempt within a month or suicidal ideation > 5 on the Beck Scale for Suicidal Ideation. Half (n = 235) will be randomized to MI-SI-R+EUC (three sessions in-person, via Video Connect, or telephone) and the remaining participants (n = 235) will receive EUC alone. All participants will be asked to complete telephone follow-up assessments at 1, 3, 6, and 12-months after randomization. This will allow the investigators to determine the efficacy of MI-SI-R+EUC in reducing risk for suicide attempts (Aim 1) and reducing overall suicidal ideation (Aim 2) when compared to EUC alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Motivational Interviewing to Address Suicidal Ideation (MI-SI-R) was developed to help participants at high-risk for suicide resolve their ambivalence about living by increasing their motivation to live, and is delivered in three sessions in-person, virtually, or by telephone.
| Arm | Type | Receives |
|---|---|---|
| Motivational Interviewing to Address Suicidal Ideation- Revised (MI-SI-R) | Experimental | Behavioral: Motivational Interviewing to Address Suicidal Ideation- Revised (MI-SI-R), Other: Enhanced usual care (EUC)Motivational Interviewing to Address Suicidal Ideation (MI-SI-R) was developed to help Veterans resolve ambivalence about living by increasing the motivation to live, and is delivered in three sessions in person, virtually, or by telephone. |
| Enhanced usual care (EUC) | Active comparator | Other: Enhanced usual care (EUC)Enhanced usual care (EUC) includes safety plans administered or reviewed by research therapists, care coordination, and access to a 24-hour crisis hotline. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Veteran status
- admitted to an inpatient unit, referred by a suicide prevention coordinator, or identified as high-risk via data extraction
- English speaking and reading
- ability to understand the study and provide informed consent
- high-risk status confirmed by suicide attempt within a month on the Columbia- Suicide Severity Rating Scale or a score > 5 on the Scale for Suicidal Ideation
Key exclusion criteria (5 listed)
- current psychosis
- active mania
- dementia
- impaired decision making capacity
- institutionalization due to hospitalization in a non-VA facility, jail, or prison
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 |
|---|---|---|
| Motivational Interviewing to Address Suicidal Ideation- Revised (MI-SI-R)Motivational Interviewing to Address Suicidal Ideation (MI-SI-R) was developed to help Veterans resolve ambivalence about living by increasing the motivation to live, that is delivered in three sessions in person, virtually, or by telephone. | Behavioural | Motivational Interviewing to Address Suicidal Ideation- Revised (MI-SI-R) |
| Enhanced usual care (EUC)Enhanced usual care (EUC) includes safety plans administered or reviewed by research therapists, care coordination, and access to a 24-hour crisis hotline. | Other | Enhanced usual care (EUC), Motivational Interviewing to Address Suicidal Ideation- Revised (MI-SI-R) |
Primary outcome
Columbia-Suicide Severity Rating Scale
Time frame: 12-months
The first primary outcome is the presence (vs. absence) of non-fatal suicide attempts as reported on the Columbia-Suicide Severity Rating Scale.
Beck Scale for Suicidal Ideation
Time frame: 12-month
The second primary outcome is suicidal ideation as reported on the Beck Scale for Suicidal Ideation, which has a range from 0-38, with higher scores indicating more severe suicidal ideation.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Individual participant dataSharing planned: Yes. Members of the scientific community who would like a copy of limited data sets (i.e., data sets underlying any publication) from this study can request a copy by e-mailing the PI at Peter.Britton@va.gov. They should state their reason for requesting the data, their plans for analyzing the data, and agree not to attempt to re-identify participants. Limited data sets will be encrypted uploaded to a protected share-point; and the password will be sent to the requestor via a separate e-mail.
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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.
Peter C. Britton, PhD MS principal investigator
VA Finger Lakes Healthcare System, Canandaigua, NY
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motivational Interviewing to Address Suicidal Ideation- Revised (MI-SI-R) in people with Suicide, Attempted and Suicidal Ideation, run by VA Office of Research and Development at 3 sites 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 5 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
This study is still under way. Results are not available in the source record yet.
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?
Columbia-Suicide Severity Rating Scale (time frame: 12-months). The study lists 2 primary outcomes in all. 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 27 Oct 2026.