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AI-DBT For Serious Illness

NCT07748312 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2026-08-05

No results posted yet for this study

Summary

Lay / General Audience Summary Many older adults living with serious illnesses experience high levels of emotional distress, including anxiety, sadness, fear, and feeling overwhelmed. These feelings often worsen as illness progresses and can make physical symptoms harder to manage, reduce quality of life, and increase the use of medications. Unfortunately, many people with serious illness cannot access mental health care because there are not enough providers, services are hard to reach, appointments are physically exhausting, or care is not available in their language.

This study will test a new way of delivering emotional support that does not require in-person therapy. The program teaches practical coping skills that help people manage strong emotions and stress. These skills are delivered through short videos and daily supportive check-ins using an automated phone or text system that people can use from home. The system is available in many languages and can be used on basic mobile phones, making it accessible to a wide range of patients.

We will enroll older adults with serious illnesses such as cancer, heart disease, lung disease, or kidney disease who are experiencing emotional distress. Participants will be randomly assigned to receive either their usual medical care alone or usual care plus the new skills program. We will examine whether people find the program easy to use, helpful, and acceptable, and whether it improves their confidence in managing difficult emotions and reduces distress.

The goal of this project is to develop a low-burden, widely accessible way to support emotional well-being for people living with serious illness. If successful, this approach could expand access to mental health support for patients who currently have few options.

Conditions

  • Serious Illness
  • Distress, Emotional
  • Distress

Interventions

BEHAVIORAL

AI DBT

The skills component of the intervention consists of 14 skills-based videos, available in English and Spanish, that are each under 5 minutes. These videos were adapted in prior research programs to be more suitable to older adults and adults with medical comorbidities. Two videos will be sent to participants per week via text message. In addition to the videos, Angel, the constrained-AI DBT skills chatbot, will check in with participants every day to collect daily-diary data and inquire if a participant is interested in a coaching session. We have also designed an orientation to the program based on protocols by the Center for Research and Education on Aging and Technology Enhancement72,73 and the Technology Acceptance Model. The intervention will be introduced during a phone call by a trained research assistant with two booster phone calls.

Sponsors & Collaborators

  • University of Colorado Denver - Anschutz Medical Campus (UCD-AMC)

    collaborator UNKNOWN

  • Rutgers, The State University of New Jersey

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-10-01
Primary Completion
2028-02-01
Completion
2028-05-15

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07748312 on ClinicalTrials.gov