Suicide ThreatNCT05582343
Modified Interactive Screening Program Plus MINDBODYSTRONG: A Mental Health Resiliency Intervention for Nurses
A study testing MINDBODYSTRONG™ in people with Suicide Threat and Burnout, Professional, run by Ohio State University at 1 site in United States.
Trial summary
The overall purpose of this study is to evaluate the efficacy of an intervention designed to prevent nurse suicide. This randomized controlled trial will test the modified Interactive Screening Program (mISP) alone and the mISP combined with a program called MINDBODYSTRONG. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Suicide Threat, Burnout, Professional, Depression
- What is being tested?
- MINDBODYSTRONG™
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 849 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Apr 2023to 10 Apr 2026
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- self-identify as a registered nurse
- identified as moderate to high risk of suicide by the mISP-specific interactive screening program assignment
Who cannot join
- low risk of suicide by the mISP-specific interactive screening program assignment
- under the age of 18 years
- prior participation in MINDBODYSTRONG
- prior participation in this study
Trial locations and contacts
1 site in 1 country.
United States1 site
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
About this study
The overall purpose of this study is to evaluate the efficacy of an intervention designed to prevent nurse suicide. This randomized controlled trial will test the modified Interactive Screening Program (mISP) alone and the mISP combined with a program called MINDBODYSTRONG.
The mISP is a method of screening to detect clinicians at moderate to high risk for suicide and referring them for treatment through an encrypted anonymous on-line platform. MINDBODYSTRONG© is an adaptation of a well-tested cognitive-behavioral skills building intervention (also known as COPE in the literature) that provides a cognitive-behavior theory-based approach to decrease depression, anxiety and suicidal ideation and improve healthy lifestyle beliefs and behaviors in at-risk populations. MINDBODYSTRONG© will involve eight self-paced computerized sessions designed specifically for nurses and clinicians. Nurses will be recruited nationally through the professional nursing organizations and health systems.
Read the detailed description
The study will be the first to test the combination of the mISP with a new on-line digitalized version of the previously tested manualized version of the CBSB program (i.e., MINDBODYSTRONG©) for nurses. If found to be effective, the combined program will be able to be easily scaled to prevent suicide in nurses and potentially other high-risk populations of clinicians. Although CBT is gold standard evidence-based treatment for depression, only a small percentage of affected individuals receive it due to a shortage of mental health providers, which contributes to high depression relapse rates of 50 to 70%. A scalable digitalized intervention could be one key solution to bringing CBT skills to nurses at risk for suicide who could so benefit from them. This randomized controlled trial (RCT) will determine the effects of the mISP, this adaptation of the American Foundation for Suicide Prevention's (AFSP) Interactive Screening program (ISP), combined with the on-line version of the MINDBODYSTRONG© program versus the HEAR program alone on depression, suicidal ideation, burnout, anxiety, post-traumatic stress, healthy lifestyle beliefs, healthy lifestyle behaviors, and job satisfaction in U.S. nurses.
- Conditions
- Suicide Threat, Burnout, Professional, Depression
- Being tested
- MINDBODYSTRONG™
- Keywords
- nurse, suicide, depression, burnout, trauma, computerized, CBT, intervention, depression screening
- Medical subject headings
- Burnout, Professional, Depression, Suicide, Burnout, Psychological, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MINDBODYSTRONG™Behavioural
Also called COPE
Digitalized MINDBODYSTRONG™ is designed for self-paced weekly use via an online platform.
MINDBODYSTRONG© Session Content
- Thinking, feeling, \& behaving, The ABCs of CBT, Mindfulness Skills Building: Positive self-talk/The ABCs
- Self-esteem \& positive self-talk, Intentional gratitude, Managing change Skills building: Self-esteem \& positive self-talk
- Stress, Healthy coping, Abdominal breathing Skills Building: Managing stress
- Problem solving, Setting goals, Steps to problem solving Skills building: Strategies to overcoming barriers
- Dealing w/ emotions in healthy ways, Using guided imagery, Coping strategies, Effective communication Skills building: Dealing with emotions
- Coping w/ stressful situations/valuable sleep Skills building: Coping w/ stressful situations
- Distress tolerance \& added emotional regulation skills Skills bulding: RAIN practice, Self-love skill, Distracting using ACCEPTS
- Putting it all together for a healthy YOU!
| Study group | Role | What they receive |
|---|---|---|
| mISP | No intervention | Participants who are identified as having moderate to high risk of suicide, as identified by suicide risk on the ISP, will be contacted by a mental health counselor who will engage them through the mISP encrypted interface online. The mental health counselor will offer counseling online through encryption or on the phone. Where indicated, the mental health counselor will provide the crisis hotline, and encourage participants to use their insurance provider and/or Employee Assistance Program to obtain treatment. The mental health counselor will offer to help with referrals and will bridge high-risk participants into treatment. Participants who are not identified as having moderate to high risk of suicide will be thanked for their time. |
| mISP plus MINDSTRONG | Active comparator | Participants identified as having a moderate to high risk of suicide based on ISP screening will then be randomized. Participants randomized to the MINDBODYSTRONG© program (intervention) will receive the 8-session online interactive program. Reminders will be sent weekly to complete the next MINDBODYSTRONG© session and a MINDBODYSTRONG© trained coach will check in with participants by phone at baseline, weeks 3 and 5 of the on-line program to reinforce key program concepts and assess whether participants are completing the weekly skills building activities. Nurses assigned to the control group will only receive the mISP alone (aforementioned) and will be contacted for follow-up surveys. Receives: Behavioral: MINDBODYSTRONG™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change is being assessed for an increase or decrease in self-reported suicidal intent
The valid and reliable Columbia Suicide Severity Rating Scale assesses the severity of suicidal ideation and behavior through a semi-structured list of yes or no questions divided into four constructs: (1) suicidal ideation; (2) intensity of ideation; (3) suicidal behavior; and (4) suicidal lethality subscale (actual or potential).
Measured: Baseline (Timepoint 0), 8 weeks after baseline (Timepoint 1), 3 months after screening (Timepoint 2), 6 months after screening (Timepoint 3), 12 months after screening (Timepoint 4)
Change in is being assessed for an increase or decrease in self-reported depressive symptoms
The 9-item valid and reliable Personal Health Questionnaire-9 will be used to measure depressive symptoms. Participants are asked to respond to nine items (e.g., little interest or pleasure in doing things; feeling down, depressed or hopeless) regarding how they have felt over the previous 2-week period. Scores are based on a 4-point Likert scale ranging from 0 "not at all" to 3 "nearly every day."
Measured: Baseline (Timepoint 0), 8 weeks after baseline (Timepoint 1), 3 months after screening (Timepoint 2), 6 months after screening (Timepoint 3), 12 months after screening (Timepoint 4)
Secondary outcomes (8)
Change in being assessed for an increase or decrease in self-reported anxiety symptoms
The valid and reliable Generalized Anxiety Disorder Scale (GAD-7) will be used to measure anxiety. The GAD-7 measures feelings and actions associated with anxiety within the prior 2-week period. Responses are based on a 4-point Likert scale ranging from 0 (not at all) to 3 (nearly everyday).
Measured: Baseline (Timepoint 0), 8 weeks after baseline (Timepoint 1), 3 months after screening (Timepoint 2), 6 months after screening (Timepoint 3), 12 months after screening (Timepoint 4)
Change is being assessed for an increase or decrease in self-reported burnout level
The following non-proprietary single-item question from the Maslach Burnout Inventory will be used to measure burnout: "Overall, based on your definition of burnout, how would you rate your level of burnout?" Responses are scored on a five-category ordinal scale, where 1 = "I enjoy my work. I have no symptoms of burnout;" 2 = "Occasionally I am under stress, and I don't always have as much energy as I once did, but I don't feel burned out;" 3 = "I am definitely burning out and have one or more symptoms of burnout, such as physical and emotional exhaustion;" 4 = "The symptoms of burnout that I'm experiencing won't go away. I think about frustration at work a lot;" and 5 = "I feel completely burned out and often wonder if I can go on. I am at the point where I may need some changes or may need to seek some sort of help."
Measured: Baseline (Timepoint 0), 8 weeks after baseline (Timepoint 1), 3 months after screening (Timepoint 2), 6 months after screening (Timepoint 3), 12 months after screening (Timepoint 4)
Change is being assessed for an increase or decrease in self-reported post-traumatic stress levels
The Primary Care PTSD Screen for DSM-5 (PC-PTSD-5) will be used to screening for post-trauma symptoms. This 5-item screening tool was developed to identify individuals with probable PTSD in a primary care setting.
Measured: Baseline (Timepoint 0), 8 weeks after baseline (Timepoint 1), 3 months after screening (Timepoint 2), 6 months after screening (Timepoint 3), 12 months after screening (Timepoint 4)
Change is being assessed for an increase or decrease in self-reported job satisfaction
Job Satisfaction will be measured using the Job Satisfaction Scale (JSS). This 7-item scale queries responses such as "I find real enjoyment in my job" and are measured on a 5-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree).
Measured: Baseline (Timepoint 0), 8 weeks after baseline (Timepoint 1), 3 months after screening (Timepoint 2), 6 months after screening (Timepoint 3), 12 months after screening (Timepoint 4)
Change is being assessed for an increase or decrease in self-reported healthy lifestyle beliefs
The Healthy Lifestyle Beliefs Scale is a 10-item scale that will be used to tap cognitive beliefs about dealing with stress/problems and engaging in healthy lifestyle behaviors, the proposed mediator in this study. Participants respond to each of the items on a 10-point Likert scale ranging from (1) strongly disagree to (5) strongly agree.
Measured: Baseline (Timepoint 0), 8 weeks after baseline (Timepoint 1), 3 months after screening (Timepoint 2), 6 months after screening (Timepoint 3), 12 months after screening (Timepoint 4)
Change is being assessed for an increase or decrease in self-reported healthy lifestyle behaviors
The Healthy Lifestyle Behaviors scale is a 16-item scale that asks for responses on statements such as "I make healthy food choices" and "I set goals I can accomplish." It us scored on a 5-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree).
Measured: Baseline (Timepoint 0), 8 weeks after baseline (Timepoint 1), 3 months after screening (Timepoint 2), 6 months after screening (Timepoint 3), 12 months after screening (Timepoint 4)
Open-ended stressors question
One previously tested question on self-reported stressors (risk factors) will be used. The question is: Please take a minute to let us know about anything that has been particularly stressful for you lately - death of a loved one, relationship break-up, academic stressors, family or money problems, difficulty with your living situation - or anything else that might be contributing to how you are feeling.
Measured: Baseline (Timepoint 0), 8 weeks after baseline (Timepoint 1), 3 months after screening (Timepoint 2), 6 months after screening (Timepoint 3), 12 months after screening (Timepoint 4)
Evaluation Questionnaire
. A questionnaire also will be administered to yield open ended feedback on the interventions in terms of their helpfulness as well as collect data on whether the nurses have received any treatment since beginning the study (e.g., therapy, medication).
Measured: 3 months after screening (Timepoint 2), 6 months after screening (Timepoint 3), 12 months after screening (Timepoint 4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2022
- Study start17 Apr 2023
- Primary completion10 Apr 2026
- Study completion10 Apr 2026
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 Suicide ThreatStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Longitudinal, randomized RCT with repeated measures
- Masking
- None (open label)
- Enrolment
- 849 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Collaborators
- American Foundation for Suicide Prevention, University of San Diego
- Responsible party
- Principal investigator, Bernadette Melnyk, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05582343
- Sponsor's protocol ID
- 2021B0417
- Other IDs
- TBT-2-007-21
- Status last verified
- Apr 2026
- First submitted
- 13 Oct 2022
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Melnyk BM, Davidson JE, Mayfield C, Zisook S, Tucker S, Hsieh AP, Cooper A, Gray-Bauer R, Hoying J, Cuccia AF, Tan A. A study protocol for the modified interactive screening program plus MINDBODYSTRONG(c) RCT: A mental health resiliency intervention for nurses. PLoS One. 2024 Jun 6;19(6):e0303425. doi: 10.1371/journal.pone.0303425. eCollection 2024.
PubMed 38843149
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modified Interactive Screening Program Plus MINDBODYSTRONG: A Mental Health Resiliency Intervention for Nurses
- ClinicalTrials.gov ID
- NCT05582343
- Acronym / sponsor ID
- 2021B0417
- Conditions
- Suicide Threat, Burnout, Professional, Depression
- Keywords
- nurse, suicide, depression, burnout, trauma, computerized, CBT, intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 849 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Collaborators
- American Foundation for Suicide Prevention, University of San Diego
- Study start
- 17 Apr 2023 (actual)
- Primary completion
- 10 Apr 2026 (actual)
- Study completion
- 10 Apr 2026 (actual)
- First posted
- 17 Oct 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 overall purpose of this study is to evaluate the efficacy of an intervention designed to prevent nurse suicide. This randomized controlled trial will test the modified Interactive Screening Program (mISP) alone and the mISP combined with a program called MINDBODYSTRONG.
The mISP is a method of screening to detect clinicians at moderate to high risk for suicide and referring them for treatment through an encrypted anonymous on-line platform. MINDBODYSTRONG© is an adaptation of a well-tested cognitive-behavioral skills building intervention (also known as COPE in the literature) that provides a cognitive-behavior theory-based approach to decrease depression, anxiety and suicidal ideation and improve healthy lifestyle beliefs and behaviors in at-risk populations. MINDBODYSTRONG© will involve eight self-paced computerized sessions designed specifically for nurses and clinicians. Nurses will be recruited nationally through the professional nursing organizations and health systems.
Detailed description
The study will be the first to test the combination of the mISP with a new on-line digitalized version of the previously tested manualized version of the CBSB program (i.e., MINDBODYSTRONG©) for nurses. If found to be effective, the combined program will be able to be easily scaled to prevent suicide in nurses and potentially other high-risk populations of clinicians. Although CBT is gold standard evidence-based treatment for depression, only a small percentage of affected individuals receive it due to a shortage of mental health providers, which contributes to high depression relapse rates of 50 to 70%. A scalable digitalized intervention could be one key solution to bringing CBT skills to nurses at risk for suicide who could so benefit from them. This randomized controlled trial (RCT) will determine the effects of the mISP, this adaptation of the American Foundation for Suicide Prevention's (AFSP) Interactive Screening program (ISP), combined with the on-line version of the MINDBODYSTRONG© program versus the HEAR program alone on depression, suicidal ideation, burnout, anxiety, post-traumatic stress, healthy lifestyle beliefs, healthy lifestyle behaviors, and job satisfaction in U.S. nurses.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Longitudinal, randomized RCT with repeated measures
| Arm | Type | Receives |
|---|---|---|
| mISP | No intervention | –Participants who are identified as having moderate to high risk of suicide, as identified by suicide risk on the ISP, will be contacted by a mental health counselor who will engage them through the mISP encrypted interface online. The mental health counselor will offer counseling online through encryption or on the phone. Where indicated, the mental health counselor will provide the crisis hotline, and encourage participants to use their insurance provider and/or Employee Assistance Program to obtain treatment. The mental health counselor will offer to help with referrals and will bridge high-risk participants into treatment. Participants who are not identified as having moderate to high risk of suicide will be thanked for their time. |
| mISP plus MINDSTRONG | Active comparator | Behavioral: MINDBODYSTRONG™Participants identified as having a moderate to high risk of suicide based on ISP screening will then be randomized. Participants randomized to the MINDBODYSTRONG© program (intervention) will receive the 8-session online interactive program. Reminders will be sent weekly to complete the next MINDBODYSTRONG© session and a MINDBODYSTRONG© trained coach will check in with participants by phone at baseline, weeks 3 and 5 of the on-line program to reinforce key program concepts and assess whether participants are completing the weekly skills building activities. Nurses assigned to the control group will only receive the mISP alone (aforementioned) and will be contacted for follow-up surveys. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- self-identify as a registered nurse
- identified as moderate to high risk of suicide by the mISP-specific interactive screening program assignment
Key exclusion criteria (4 listed)
- low risk of suicide by the mISP-specific interactive screening program assignment
- under the age of 18 years
- prior participation in MINDBODYSTRONG
- prior participation in this study
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 |
|---|---|---|
| MINDBODYSTRONG™Also: COPEDigitalized MINDBODYSTRONG™ is designed for self-paced weekly use via an online platform. MINDBODYSTRONG© Session Content 1. Thinking, feeling, \& behaving, The ABCs of CBT, Mindfulness Skills Building: Positive self-talk/The ABCs 2. Self-esteem \& positive self-talk, Intentional gratitude, Managing change Skills building: Self-esteem \& positive self-talk 3. Stress, Healthy coping, Abdominal breathing Skills Building: Managing stress 4. Problem solving, Setting goals, Steps to problem solving Skills building: Strategies to overcoming barriers 5. Dealing w/ emotions in healthy ways, Using guided imagery, Coping strategies, Effective communication Skills building: Dealing with emotions 6. Coping w/ stressful situations/valuable sleep Skills building: Coping w/ stressful situations 7. Distress tolerance \& added emotional regulation skills Skills bulding: RAIN practice, Self-love skill, Distracting using ACCEPTS 8. Putting it all together for a healthy YOU! | Behavioural | mISP plus MINDSTRONG |
Primary outcome
Change is being assessed for an increase or decrease in self-reported suicidal intent
Time frame: Baseline (Timepoint 0), 8 weeks after baseline (Timepoint 1), 3 months after screening (Timepoint 2), 6 months after screening (Timepoint 3), 12 months after screening (Timepoint 4)
The valid and reliable Columbia Suicide Severity Rating Scale assesses the severity of suicidal ideation and behavior through a semi-structured list of yes or no questions divided into four constructs: (1) suicidal ideation; (2) intensity of ideation; (3) suicidal behavior; and (4) suicidal lethality subscale (actual or potential).
Change in is being assessed for an increase or decrease in self-reported depressive symptoms
Time frame: Baseline (Timepoint 0), 8 weeks after baseline (Timepoint 1), 3 months after screening (Timepoint 2), 6 months after screening (Timepoint 3), 12 months after screening (Timepoint 4)
The 9-item valid and reliable Personal Health Questionnaire-9 will be used to measure depressive symptoms. Participants are asked to respond to nine items (e.g., little interest or pleasure in doing things; feeling down, depressed or hopeless) regarding how they have felt over the previous 2-week period. Scores are based on a 4-point Likert scale ranging from 0 "not at all" to 3 "nearly every day."
8 secondary outcomes
Change in being assessed for an increase or decrease in self-reported anxiety symptoms
Time frame: Baseline (Timepoint 0), 8 weeks after baseline (Timepoint 1), 3 months after screening (Timepoint 2), 6 months after screening (Timepoint 3), 12 months after screening (Timepoint 4)
Change is being assessed for an increase or decrease in self-reported burnout level
Time frame: Baseline (Timepoint 0), 8 weeks after baseline (Timepoint 1), 3 months after screening (Timepoint 2), 6 months after screening (Timepoint 3), 12 months after screening (Timepoint 4)
Change is being assessed for an increase or decrease in self-reported post-traumatic stress levels
Time frame: Baseline (Timepoint 0), 8 weeks after baseline (Timepoint 1), 3 months after screening (Timepoint 2), 6 months after screening (Timepoint 3), 12 months after screening (Timepoint 4)
Change is being assessed for an increase or decrease in self-reported job satisfaction
Time frame: Baseline (Timepoint 0), 8 weeks after baseline (Timepoint 1), 3 months after screening (Timepoint 2), 6 months after screening (Timepoint 3), 12 months after screening (Timepoint 4)
Change is being assessed for an increase or decrease in self-reported healthy lifestyle beliefs
Time frame: Baseline (Timepoint 0), 8 weeks after baseline (Timepoint 1), 3 months after screening (Timepoint 2), 6 months after screening (Timepoint 3), 12 months after screening (Timepoint 4)
Change is being assessed for an increase or decrease in self-reported healthy lifestyle behaviors
Time frame: Baseline (Timepoint 0), 8 weeks after baseline (Timepoint 1), 3 months after screening (Timepoint 2), 6 months after screening (Timepoint 3), 12 months after screening (Timepoint 4)
Open-ended stressors question
Time frame: Baseline (Timepoint 0), 8 weeks after baseline (Timepoint 1), 3 months after screening (Timepoint 2), 6 months after screening (Timepoint 3), 12 months after screening (Timepoint 4)
Evaluation Questionnaire
Time frame: 3 months after screening (Timepoint 2), 6 months after screening (Timepoint 3), 12 months after screening (Timepoint 4)
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 5 May 2026.
- Derived from this study: PubMed 38843149Melnyk BM, Davidson JE, Mayfield C, Zisook S, Tucker S, Hsieh AP, Cooper A, Gray-Bauer R, Hoying J, Cuccia AF, Tan A. A study protocol for the modified interactive screening program plus MINDBODYSTRONG(c) RCT: A mental health resiliency intervention for nurses. PLoS One. 2024 Jun 6;19(6):e0303425. doi: 10.1371/journal.pone.0303425. eCollection 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MINDBODYSTRONG™ in people with Suicide Threat and Burnout, Professional, run by Ohio State University 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 2 inclusion and 4 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 5 May 2026. 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?
Change is being assessed for an increase or decrease in self-reported suicidal intent (time frame: Baseline (Timepoint 0), 8 weeks after baseline (Timepoint 1), 3 months after screening (Timepoint 2), 6 months after screening (Timepoint 3), 12 months after screening (Timepoint 4)). 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 NCT05582343, 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 5 May 2026; AzTrials last refreshed its copy on 26 Oct 2026.