Suicidal IdeationNCT01544127
Motivational Interviewing to Prevent Suicide in High Risk Veterans
A study testing MI-SI+TAU, MI-SI-R+TAU and TAU Alone in people with Suicidal Ideation and Treatment Engagement, run by VA Office of Research and Development at 1 site in United States.
Trial summary
The purpose of study is to test the efficacy of an adaptation of Motivational Interviewing to Address Suicidal Ideation (MI-SI) on the severity of suicidal ideation in psychiatrically hospitalized Veterans at high risk for suicide. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Suicidal Ideation, Treatment Engagement
- What is being tested?
- MI-SI+TAU, MI-SI-R+TAU and TAU Alone
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jul 2012to 5 Dec 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 psychiatric inpatient unit,
- age 18 and over,
- English speaking,
- able to understand the study and provide informed consent,
- clinically cleared to participate by unit staff,
- receive health care from a VHA facility in upstate New York
- at increased risk for suicide (Scale for Suicidal Ideation [SSI] > 2)
Who cannot join
- current psychosis,
- current mania,
- dementia,
- prisoner status,
- being inaccessible
- being discharged from the unit less than 48 hours after being identified by study staff
Trial locations and contacts
1 site in 1 country.
United States1 site
Syracuse VA Medical Center, Syracuse, NY
Syracuse, New York, 13210
About this study
The purpose of study is to test the efficacy of an adaptation of Motivational Interviewing to Address Suicidal Ideation (MI-SI) on the severity of suicidal ideation in psychiatrically hospitalized Veterans at high risk for suicide.
Read the detailed description
Veterans who receive health care from the VA are at elevated risk for suicide, and the number of Veterans at high risk may be growing. Although the months following discharge from psychiatric hospitalization are a period of acute risk for Veterans, there is a dearth of empirically supported treatments tailored to psychiatric inpatients and no studies examining treatments for psychiatrically hospitalized Veterans. This randomized controlled trial will test the efficacy of an adaptation of Motivational Interviewing to Address Suicidal Ideation (MI-SI) on the severity of suicidal ideation in psychiatrically hospitalized Veterans at high risk for suicide. Participants will be recruited from the Acute Psychiatric Inpatient Unit at the Syracuse VA Medical Center. To meet high-risk criteria, Veterans must score over two on the Scale for Suicidal Ideation (SSI), which is prospectively predictive of death by suicide. Participants will complete a screening assessment to confirm eligibility and a baseline assessment of risk factors for suicide. They will be randomized to receive Motivational Interviewing to Address Suicidal Ideation (MI-SI) or a revised version (MI-SI-R) plus treatment as usual (TAU), or TAU alone. The MI-SI groups will receive two sessions of MI-SI during hospitalization and one telephone booster session after discharge. Participants in all conditions will be asked to complete telephone follow-up interviews at 1, 3, and 6 months after discharge. Change in the severity of suicidal ideation will be measured using the SSI.
- Conditions
- Suicidal Ideation, Treatment Engagement
- Being tested
- MI-SI+TAU, MI-SI-R+TAU, TAU Alone
- Keywords
- Veterans, Motivational Interviewing, Inpatients, Suicide, Attempted
- Medical subject headings
- Suicidal Ideation, Suicide, Attempted
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MI-SI+TAUBehavioural
Also called Motivational Interviewing to Address Suicidal Ideation
MI-SI focuses on exploring and resolving ambivalence about living. It consists of 1 or 2 in-person MI-SI sessions (50 mins.) on an inpatient unit, plus a telephone follow-up MI-SI session (30-50 mins)
MI-SI-R+TAUBehavioural
Also called MI-SI Revised
MI-SI-R focuses on resolving ambivalence about living. It consists of 1 or 2 in-person MI-SI sessions (50 mins.) on an inpatient unit, plus a telephone follow-up MI-SI session (30-50 mins)
TAU AloneOther
Also called Treatment as usual
Inpatient treatment includes medication management, case management, meals and a bed, milieu therapy consisting of creative and social activities, and a safety plan. Some families of veterans also received education to create a supportive home environment. As part of Veterans Health Administration (VHA) suicide prevention policy, the care of suicidal patients is also overseen by a local Suicide Prevention Coordinator and case managers.
| Study group | Role | What they receive |
|---|---|---|
| MI-SI+TAU | Experimental | Motivational Interviewing to Address Suicidal Ideation Receives: Behavioral: MI-SI+TAU |
| MI-SI-R+TAU | Experimental | Motivational Interviewing to Address Suicidal Ideation Revised Receives: Behavioral: MI-SI-R+TAU |
| TAU Alone | Other | Treatment as usual Receives: Other: TAU Alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Suicidal Ideation
The number of participants with suicidal ideation and severity of suicidal ideation was measured using the Scale for Suicidal Ideation (SSI) at 1, 3, and 6 months after discharge. Scores range from 0-38, with scores of 1 or greater indicating the presence of suicidal ideation.
Measured: 6 months
Severity of Suicidal Ideation Among Those With It
Severity of suicidal ideation was measured by the Scale for Suicidal Ideation at 1, 3, and 6 months after discharge. Scores range from 0 to 38, with higher scores indicating more severe suicidal ideation.
Measured: 6 months
Secondary outcomes (1)
Number of Participants With Two Outpatient Mental Health or Substance Treatment Sessions
Treatment engagement was measured using the Treatment Services Review-6 (TSR-6) at 1 month after discharge.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2012 (estimated)
- Study start30 Jul 2012
- Primary completion5 Dec 2017
- Study completion5 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Suicidal IdeationStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Peter C. Britton, PhD MS, Principal investigator, Syracuse VA Medical Center, Syracuse, NY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01544127
- Sponsor's protocol ID
- MHBA-20-11S
- Other IDs
- IK2CX00064
- Status last verified
- Feb 2022
- First submitted
- 28 Feb 2012
- Last updated
- 25 Feb 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Britton PC, Conner KR, Chapman BP, Maisto SA. Motivational Interviewing to Address Suicidal Ideation: A Randomized Controlled Trial in Veterans. Suicide Life Threat Behav. 2020 Feb;50(1):233-248. doi: 10.1111/sltb.12581. Epub 2019 Aug 8.
PubMed 31393029
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Motivational Interviewing to Prevent Suicide in High Risk Veterans
- ClinicalTrials.gov ID
- NCT01544127
- Acronym / sponsor ID
- MHBA-20-11S
- Conditions
- Suicidal Ideation, Treatment Engagement
- Keywords
- Veterans, Motivational Interviewing, Inpatients, Suicide, Attempted
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 30 Jul 2012 (actual)
- Primary completion
- 5 Dec 2017 (actual)
- Study completion
- 5 Dec 2017 (actual)
- First posted
- 5 Mar 2012 (estimated)
- Results
- Posted 11 Sep 2019
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 study is to test the efficacy of an adaptation of Motivational Interviewing to Address Suicidal Ideation (MI-SI) on the severity of suicidal ideation in psychiatrically hospitalized Veterans at high risk for suicide.
Detailed description
Veterans who receive health care from the VA are at elevated risk for suicide, and the number of Veterans at high risk may be growing. Although the months following discharge from psychiatric hospitalization are a period of acute risk for Veterans, there is a dearth of empirically supported treatments tailored to psychiatric inpatients and no studies examining treatments for psychiatrically hospitalized Veterans. This randomized controlled trial will test the efficacy of an adaptation of Motivational Interviewing to Address Suicidal Ideation (MI-SI) on the severity of suicidal ideation in psychiatrically hospitalized Veterans at high risk for suicide. Participants will be recruited from the Acute Psychiatric Inpatient Unit at the Syracuse VA Medical Center. To meet high-risk criteria, Veterans must score over two on the Scale for Suicidal Ideation (SSI), which is prospectively predictive of death by suicide. Participants will complete a screening assessment to confirm eligibility and a baseline assessment of risk factors for suicide. They will be randomized to receive Motivational Interviewing to Address Suicidal Ideation (MI-SI) or a revised version (MI-SI-R) plus treatment as usual (TAU), or TAU alone. The MI-SI groups will receive two sessions of MI-SI during hospitalization and one telephone booster session after discharge. Participants in all conditions will be asked to complete telephone follow-up interviews at 1, 3, and 6 months after discharge. Change in the severity of suicidal ideation will be measured using the SSI.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| MI-SI+TAU | Experimental | Behavioral: MI-SI+TAUMotivational Interviewing to Address Suicidal Ideation |
| MI-SI-R+TAU | Experimental | Behavioral: MI-SI-R+TAUMotivational Interviewing to Address Suicidal Ideation Revised |
| TAU Alone | Other | Other: TAU AloneTreatment as usual |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Veteran status,
- admitted to psychiatric inpatient unit,
- age 18 and over,
- English speaking,
- able to understand the study and provide informed consent,
Key exclusion criteria (6 listed)
- current psychosis,
- current mania,
- dementia,
- prisoner status,
- being inaccessible
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 |
|---|---|---|
| MI-SI+TAUAlso: Motivational Interviewing to Address Suicidal IdeationMI-SI focuses on exploring and resolving ambivalence about living. It consists of 1 or 2 in-person MI-SI sessions (50 mins.) on an inpatient unit, plus a telephone follow-up MI-SI session (30-50 mins) | Behavioural | MI-SI+TAU |
| MI-SI-R+TAUAlso: MI-SI RevisedMI-SI-R focuses on resolving ambivalence about living. It consists of 1 or 2 in-person MI-SI sessions (50 mins.) on an inpatient unit, plus a telephone follow-up MI-SI session (30-50 mins) | Behavioural | MI-SI-R+TAU |
| TAU AloneAlso: Treatment as usualInpatient treatment includes medication management, case management, meals and a bed, milieu therapy consisting of creative and social activities, and a safety plan. Some families of veterans also received education to create a supportive home environment. As part of Veterans Health Administration (VHA) suicide prevention policy, the care of suicidal patients is also overseen by a local Suicide Prevention Coordinator and case managers. | Other | TAU Alone |
Primary outcome
Number of Participants With Suicidal Ideation
Time frame: 6 months
The number of participants with suicidal ideation and severity of suicidal ideation was measured using the Scale for Suicidal Ideation (SSI) at 1, 3, and 6 months after discharge. Scores range from 0-38, with scores of 1 or greater indicating the presence of suicidal ideation.
Severity of Suicidal Ideation Among Those With It
Time frame: 6 months
Severity of suicidal ideation was measured by the Scale for Suicidal Ideation at 1, 3, and 6 months after discharge. Scores range from 0 to 38, with higher scores indicating more severe suicidal ideation.
1 secondary outcome
Number of Participants With Two Outpatient Mental Health or Substance Treatment Sessions
Time frame: 1 month
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31393029Britton PC, Conner KR, Chapman BP, Maisto SA. Motivational Interviewing to Address Suicidal Ideation: A Randomized Controlled Trial in Veterans. Suicide Life Threat Behav. 2020 Feb;50(1):233-248. doi: 10.1111/sltb.12581. Epub 2019 Aug 8.
- 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.
Peter C. Britton, PhD MS principal investigator
Syracuse VA Medical Center, Syracuse, NY
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MI-SI+TAU, MI-SI-R+TAU and TAU Alone in people with Suicidal Ideation and Treatment Engagement, run by VA Office of Research and Development 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 8 inclusion and 6 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 25 Feb 2022. 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?
Yes. Results are posted in the registry (first posted 11 Sep 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Suicidal Ideation (time frame: 6 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?
On the ClinicalTrials.gov record for NCT01544127, 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 25 Feb 2022.