Suicidal Ideation and BehaviorNCT07339189
HIV Suicide Prevention With AI-DBT
A study testing AI-DBT in people with Suicidal Ideation and Behavior and HIV, run by Rutgers, The State University of New Jersey at 2 sites in United States.
Trial summary
One in four older persons living with HIV/AIDS (PLWHA) report at least one suicide attempt in their lifetime, and the risk for death by suicide is 100 times higher in PLWHA than in the general population. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Suicidal Ideation and Behavior, HIV, AIDS (Acquired Immune Deficiency Syndrome)
- What is being tested?
- AI-DBT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesUnited States
- Study dates
- 7 Jan 2026to Jun 2028
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 50+
- evidence of suicide risk as defined by at least one of the following: PHQ-9 suicide item > 0, Ask Suicide Questions (ASQ, an NIMH-supported suicide risk screener with a version tailored for primary care) > 0, expression of suicidal thoughts to the provider during appointment, a suicide attempt in the past year, or PHQ-9 total score ≥ 8,
- ability to read and communicate fluently in English or Spanish
- not at imminent risk for suicide (does not have significant intent to die within 48 hours)
- has a smartphone capable of texting and accessing the internet.
Who cannot join
- deemed clinically inappropriate to participate because of severe psychosis, severe substance use, or severe cognitive deficits that would interfere with their comprehending study and intervention material.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
New Jersey Community Research Initiative
Newark, New Jersey, 07103
- Not yet recruiting
RWJB Infectious Disease
Newark, New Jersey, 07112
Jared Khan, MPH, khanjj@sph.rutgers.edu
About this study
Official title: Piloting AI-Delivered Dialectical Behavioral Therapy for Suicide Prevention in Older Patients Living With HIV
One in four older persons living with HIV/AIDS (PLWHA) report at least one suicide attempt in their lifetime, and the risk for death by suicide is 100 times higher in PLWHA than in the general population. Currently, there are no behavioral interventions that specifically address suicide prevention for older PLWHA, despite their unique biopsychosocial and structural risk factors. Through this work, investigators will adapt Dialectical Behavior Therapy, an evidence-based intervention for suicide prevention, for patients with PLWHA to be delivered by an AI-powered conversational Agent developed by our industry partner, Empower Health. Investigators will then pilot test the feasibility, usability, acceptability and preliminary efficacy to improve self-efficacy to manage negative emotions in n=50 older adults living with HIV/AIDS.
Read the detailed description
One in four older persons living with HIV/AIDS (PLWHA) report at least one suicide attempt in their lifetime, and the risk of death by suicide is 100 times higher in PLWHA than in the general population. In the United States, there are approximately 1.2 million PLWHA, and 35% are adults aged 55 and over. Older PLWHA experience unique combinations of stressors including externalized and internalized stigma from advanced age and disease status. Despite the increased risk and unique risk factors older PLWHA have for suicide mortality, there have been no interventions developed specifically for this population to address suicide risk. Dialectical Behavioral Therapy (DBT) shows significant impact at reducing suicidal behaviors by improving one's self-efficacy to manage negative emotions. DBT has never been evaluated with PLWHA for suicide prevention, representing a critical gap in the science. Innovative solutions to mental health care, such as AI-powered chatbots, have also not been studied extensively in older PLWHA. The objective of this R34 Intervention Development and Pilot grant proposal is to adapt DBT Skills and Coaching for suicide prevention in older PLWHA to be delivered via brief videos and Angel. Angel is an artificial intelligence (AI)-powered conversational agent developed by CareAngel, a company that leverages cutting edge AI and natural language processing technology. Investigators plan to adapt existing evidence-based DBT skills videos and add coaching support from Angel in a 6-week intervention with older PLWHA. This proposal has the following specific aims: Phase 1: Adaptation: Aim 1) To adapt DBT Skills and Coaching for PLWHA seeking care in infectious disease practices to be delivered via Angel. Phase 2: Pilot feasibility and preliminary efficacy RCT with n=50 PLWHA: Aim 2) To establish the feasibility, acceptability, and usability of the adapted DBT Skills and Coaching intervention through key metrics of use, survey item responses, and qualitative interviews surrounding barriers and facilitators to use with patients enrolled in the intervention. Aim 3) To explore the preliminary efficacy, relative to usual care control, of DBT skills videos and Angel-delivered DBT Coaching on the target mechanism, self-efficacy to manage negative emotions, as well as exploratory clinical outcomes including suicide outcomes, mood, and medical treatment adherence. This proposed work is of high scientific and public health significance for numerous reasons: 1.) older PLWHA have elevated suicide risk. 2.) there is a paucity of suicide prevention intervention research for PLWHA. 3.) while Dialectical Behavioral Therapy has been studied in over 30 randomized controlled trials with demonstrated efficacy to improve psychological outcomes in diverse populations, to our knowledge, this intervention has never been piloted with older PLWHA. 4.) Innovative solutions to mental health care, such as AI-powered chatbots + videos, have not been studied in older PLWHA, thus this proposal represents an exciting opportunity to fill critical gaps in the literature on potentially scalable, implementable, and effective approaches to suicide prevention in PLWHA.
- Being tested
- AI-DBT
- Keywords
- suicide, HIV, mHealth
- Medical subject headings
- Suicidal Ideation, Behavior, Acquired Immunodeficiency Syndrome, Suicide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI-DBTBehavioural
Participants will receive 14, 5 minute videos delivered 2x/week that describe DBT skills and tools. They will also receive the option of engaging in coaching sessions.
| Study group | Role | What they receive |
|---|---|---|
| usual care | No intervention | Usual care |
| AI-DBT | Experimental | AI-DBT group will receive 14 videos under 5 minutes across 7 weeks and the opportunity to engage in skills coaching with an AI chatbot Receives: Behavioral: AI-DBT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-efficacy to manage emotions
Scale to determine if someone has self-efficacy to manage negative emotions
Measured: baseline, 6 and 12 weeks for long-form.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2026
- Study start7 Jan 2026
- Primary completionJun 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Suicidal Ideation and BehaviorStudies of the same condition, open and under way.
- More trials run by Rutgers, The State University of New JerseyThe 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
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Elissa Kozlov, Ph.D, Rutgers, The State University of New Jersey
- Investigators
- Elissa Kozlov, PhD, Principal investigator, Rutgers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07339189
- Sponsor's protocol ID
- PRO2024000600
- Other IDs
- R34MH134693
- Status last verified
- Jan 2026
- First submitted
- 12 Jan 2026
- Last updated
- 15 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The plan is to share data with the NIMH NDA repository.
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Piloting AI-Delivered Dialectical Behavioral Therapy for Suicide Prevention in Older Patients Living With HIV
- ClinicalTrials.gov ID
- NCT07339189
- Acronym / sponsor ID
- PRO2024000600
- Keywords
- suicide, HIV, mHealth
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 7 Jan 2026 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 14 Jan 2026 (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.
One in four older persons living with HIV/AIDS (PLWHA) report at least one suicide attempt in their lifetime, and the risk for death by suicide is 100 times higher in PLWHA than in the general population. Currently, there are no behavioral interventions that specifically address suicide prevention for older PLWHA, despite their unique biopsychosocial and structural risk factors. Through this work, investigators will adapt Dialectical Behavior Therapy, an evidence-based intervention for suicide prevention, for patients with PLWHA to be delivered by an AI-powered conversational Agent developed by our industry partner, Empower Health. Investigators will then pilot test the feasibility, usability, acceptability and preliminary efficacy to improve self-efficacy to manage negative emotions in n=50 older adults living with HIV/AIDS.
Detailed description
One in four older persons living with HIV/AIDS (PLWHA) report at least one suicide attempt in their lifetime, and the risk of death by suicide is 100 times higher in PLWHA than in the general population. In the United States, there are approximately 1.2 million PLWHA, and 35% are adults aged 55 and over. Older PLWHA experience unique combinations of stressors including externalized and internalized stigma from advanced age and disease status. Despite the increased risk and unique risk factors older PLWHA have for suicide mortality, there have been no interventions developed specifically for this population to address suicide risk. Dialectical Behavioral Therapy (DBT) shows significant impact at reducing suicidal behaviors by improving one's self-efficacy to manage negative emotions. DBT has never been evaluated with PLWHA for suicide prevention, representing a critical gap in the science. Innovative solutions to mental health care, such as AI-powered chatbots, have also not been studied extensively in older PLWHA. The objective of this R34 Intervention Development and Pilot grant proposal is to adapt DBT Skills and Coaching for suicide prevention in older PLWHA to be delivered via brief videos and Angel. Angel is an artificial intelligence (AI)-powered conversational agent developed by CareAngel, a company that leverages cutting edge AI and natural language processing technology. Investigators plan to adapt existing evidence-based DBT skills videos and add coaching support from Angel in a 6-week intervention with older PLWHA. This proposal has the following specific aims: Phase 1: Adaptation: Aim 1) To adapt DBT Skills and Coaching for PLWHA seeking care in infectious disease practices to be delivered via Angel. Phase 2: Pilot feasibility and preliminary efficacy RCT with n=50 PLWHA: Aim 2) To establish the feasibility, acceptability, and usability of the adapted DBT Skills and Coaching intervention through key metrics of use, survey item responses, and qualitative interviews surrounding barriers and facilitators to use with patients enrolled in the intervention. Aim 3) To explore the preliminary efficacy, relative to usual care control, of DBT skills videos and Angel-delivered DBT Coaching on the target mechanism, self-efficacy to manage negative emotions, as well as exploratory clinical outcomes including suicide outcomes, mood, and medical treatment adherence. This proposed work is of high scientific and public health significance for numerous reasons: 1.) older PLWHA have elevated suicide risk. 2.) there is a paucity of suicide prevention intervention research for PLWHA. 3.) while Dialectical Behavioral Therapy has been studied in over 30 randomized controlled trials with demonstrated efficacy to improve psychological outcomes in diverse populations, to our knowledge, this intervention has never been piloted with older PLWHA. 4.) Innovative solutions to mental health care, such as AI-powered chatbots + videos, have not been studied in older PLWHA, thus this proposal represents an exciting opportunity to fill critical gaps in the literature on potentially scalable, implementable, and effective approaches to suicide prevention in PLWHA.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| usual care | No intervention | –Usual care |
| AI-DBT | Experimental | Behavioral: AI-DBTAI-DBT group will receive 14 videos under 5 minutes across 7 weeks and the opportunity to engage in skills coaching with an AI chatbot |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged 50+
- evidence of suicide risk as defined by at least one of the following: PHQ-9 suicide item > 0, Ask Suicide Questions (ASQ, an NIMH-supported suicide risk screener with a version tailored for primary care) > 0, expression of suicidal thoughts to the provider during appointment, a suicide attempt in the past year, or PHQ-9 total score ≥ 8,
- ability to read and communicate fluently in English or Spanish
- not at imminent risk for suicide (does not have significant intent to die within 48 hours)
- has a smartphone capable of texting and accessing the internet.
Key exclusion criteria (1 listed)
- deemed clinically inappropriate to participate because of severe psychosis, severe substance use, or severe cognitive deficits that would interfere with their comprehending study and intervention material.
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 |
|---|---|---|
| AI-DBTParticipants will receive 14, 5 minute videos delivered 2x/week that describe DBT skills and tools. They will also receive the option of engaging in coaching sessions. | Behavioural | AI-DBT |
Primary outcome
Self-efficacy to manage emotions
Time frame: baseline, 6 and 12 weeks for long-form.
Scale to determine if someone has self-efficacy to manage negative emotions
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 15 Jan 2026.
- Individual participant dataSharing planned: No. The plan is to share data with the NIMH NDA repository.
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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.
Elissa Kozlov, PhD principal investigator
Rutgers
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AI-DBT in people with Suicidal Ideation and Behavior and HIV, run by Rutgers, The State University of New Jersey at 2 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 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: looking for participants now, as of the sponsor's last update on 15 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Contact Jared Khan, MPH (2016672414, khanjj@sph.rutgers.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-efficacy to manage emotions (time frame: baseline, 6 and 12 weeks for long-form.). 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 15 Jan 2026.