Recruiting

Dialectical Behavior Therapy

Sponsor:

Rutgers, The State University of New Jersey

Code:

NCT07339189

Conditions

Suicidal Ideation and Behavior

HIV

AIDS (Acquired Immune Deficiency Syndrome)

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Not accepted

Interventions

AI-DBT

Study Details

Brief 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. 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.

Conditions

Suicidal Ideation and Behavior

HIV

AIDS (Acquired Immune Deficiency Syndrome)

Study ID

NCT07339189

Start date

Jan 7, 2026

Status verified date

Jan, 2026

Completion date

Jun, 2028

Anticipated

Primary completion date

Jun, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Not accepted

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 Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

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

Interventions

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.

Primary outcome measure

  • Self-efficacy to manage emotions [ Time Frame: baseline, 6 and 12 weeks for long-form. ]

Central Contacts and Locations

Central contacts

Jared Khan, MPH

2016672414khanjj@sph.rutgers.edu

Locations

New Jersey Community Research Initiative

Recruiting

Newark, New Jersey, United States, 07103

More Information

Sponsor

Rutgers, The State University of New Jersey

Last update posted

Jan 15, 2026

Last verified

Jan, 2026

Keywords

  • suicide
  • HIV
  • mHealth

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Rutgers, The State University of New Jersey on 2026-01-15.