HIV Suicide Prevention With AI-DBT

January 14, 2026 updated by: Elissa Kozlov, Ph.D, Rutgers, The State University of New Jersey

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • New Jersey
      • Newark, New Jersey, United States, 07103
        • Recruiting
        • New Jersey Community Research Initiative
      • Newark, New Jersey, United States, 07112

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: usual care
Usual care
Experimental: AI-DBT
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
Behavioral: AI-DBT
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
baseline, 6 and 12 weeks for long-form.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rutgers, The State University of New Jersey

Collaborators

National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: Elissa Kozlov, PhD, Rutgers

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 7, 2026

Primary Completion (Estimated)

June 1, 2028

Study Completion (Estimated)

June 1, 2028

Study Registration Dates

First Submitted

January 12, 2026

First Submitted That Met QC Criteria

January 12, 2026

First Posted (Estimated)

January 14, 2026

Study Record Updates

Last Update Posted (Actual)

January 15, 2026

Last Update Submitted That Met QC Criteria

January 14, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRO2024000600
  • R34MH134693 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The plan is to share data with the NIMH NDA repository.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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