Serious IllnessPhase 1NCT07748312
AI-DBT For Serious Illness
A Phase 1 study testing AI DBT in people with Serious Illness and Distress, Emotional, run by Rutgers, The State University of New Jersey.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Serious Illness, Distress, Emotional, Distress
- 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
- 80 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2026to 15 May 2028
- Phase
- Phase 1
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- -
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Pilot Testing AI-Delivered Dialectical Behavioral Therapy Skills and Coaching in Older Patients With Serious Illness
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.
Read more
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.
Read the detailed description
Project Abstract
Psychological distress is prevalent among older adults with serious illness, affecting approximately 30-50% of patients. Psychological distress is associated with greater symptom burden, poorer quality of life, higher health care utilization, and potentially inappropriate medication use. Despite its clinical significance, access to evidence-based psychological care remains limited due to workforce shortages, Medicare access constraints, transportation barriers, cost, and poor scalability of traditional in-person psychotherapy. As a result, psychological outcomes in serious illness care remain suboptimal.
Dialectical Behavior Therapy (DBT) is a principle-based, skills-focused intervention with strong transdiagnostic efficacy across psychiatric and medical populations. DBT's emphasis on strengthening self-efficacy to manage negative emotions, a core mechanism underlying diverse forms of psychological distress, makes it particularly well suited to serious illness populations characterized by multimorbidity and fluctuating symptomatology. However, DBT has limited research in serious illness, largely due to its reliance on frequent sessions with trained providers.
This project will evaluate the feasibility, acceptability, and preliminary efficacy of a video and AI-chatbot-delivered DBT skills and coaching (AI-DBT) for older adults with serious illness and elevated psychological distress. AI-DBT was developed and refined through prior funded studies and delivers brief DBT skills videos combined with coaching via a multilingual, constrained-logic conversational agent accessible by phone or text. In a pilot randomized controlled trial (n=80), participants with serious illness and psychological distress will be randomized to usual care or usual care plus AI-DBT.
Aim 1 will assess feasibility and acceptability using recruitment, retention, engagement metrics, participant-reported satisfaction, and qualitative interviews. Aim 2 will examine preliminary efficacy on the mechanistic target of self-efficacy to manage emotions and exploratory clinical outcomes including psychological distress, anxiety, depression, and quality of life.This study will generate critical early-stage data to support a future R01 and advance scalable, mechanism-driven psychosocial care for people living with serious illness.
- Conditions
- Serious Illness, Distress, Emotional, Distress
- Being tested
- AI DBT
- Keywords
- serious illness, mental health, AI, DBT, distress
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI DBTBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| control | No intervention | Usual Care Control Condition: Participants randomized to the usual care condition will continue to receive all medical and psychosocial services routinely available to them through their existing care teams (e.g., primary care, oncology, cardiology, nephrology, palliative care, social work). Variation in usual care across clinical contexts is an expected and intentional feature of this study. AI-DBT is designed as an additive intervention that can be layered onto existing care, regardless of diagnosis or setting. |
| intervention | Experimental | 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. Receives: Behavioral: AI DBT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability
Acceptability will be measured quantitatively using the Acceptability of Intervention Measure and Intervention Appropriateness Measure
Measured: 8 weeks
Feasibility
Feasibility is defined by the number of unique videos watched. If a participant watches 9 or more of the 14 videos, engagement will be achieved.
Measured: 8 weeks
Preliminary efficacy
DBT ways of Coping Checklist
Measured: 8 weeks
Secondary outcomes (3)
depressive symptoms
Depression as measured by the PHQ 9
Measured: 8 weeks
anxiety
GAD-7
Measured: 8 weeks
psychological distress
psychological distress thermometer
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 Feb 2028 (estimated)
- Study completion15 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Serious IllnessStudies of the same condition, open and under way.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Collaborators
- University of Colorado, Denver
- Responsible party
- Principal investigator, Elissa Kozlov, Ph.D, Rutgers, The State University of New Jersey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07748312
- Sponsor's protocol ID
- Pro2026000988
- Other IDs
- 1U54AG093230-01
- Status last verified
- Aug 2026
- First submitted
- 29 Jul 2026
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: patient demographics, clinical characteristics, analysis code, qualitative interviews will all be shared with the Ascent deidentified data repository at the University of Colorado.
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Testing AI-Delivered Dialectical Behavioral Therapy Skills and Coaching in Older Patients With Serious Illness
- ClinicalTrials.gov ID
- NCT07748312
- Acronym / sponsor ID
- Pro2026000988
- Conditions
- Serious Illness, Distress, Emotional, Distress
- Keywords
- serious illness, mental health, AI, DBT, distress
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Collaborators
- University of Colorado, Denver
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 1 Feb 2028 (estimated)
- Study completion
- 15 May 2028 (estimated)
- First posted
- 5 Aug 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.
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.
Detailed description
Project Abstract
Psychological distress is prevalent among older adults with serious illness, affecting approximately 30-50% of patients. Psychological distress is associated with greater symptom burden, poorer quality of life, higher health care utilization, and potentially inappropriate medication use. Despite its clinical significance, access to evidence-based psychological care remains limited due to workforce shortages, Medicare access constraints, transportation barriers, cost, and poor scalability of traditional in-person psychotherapy. As a result, psychological outcomes in serious illness care remain suboptimal.
Dialectical Behavior Therapy (DBT) is a principle-based, skills-focused intervention with strong transdiagnostic efficacy across psychiatric and medical populations. DBT's emphasis on strengthening self-efficacy to manage negative emotions, a core mechanism underlying diverse forms of psychological distress, makes it particularly well suited to serious illness populations characterized by multimorbidity and fluctuating symptomatology. However, DBT has limited research in serious illness, largely due to its reliance on frequent sessions with trained providers.
This project will evaluate the feasibility, acceptability, and preliminary efficacy of a video and AI-chatbot-delivered DBT skills and coaching (AI-DBT) for older adults with serious illness and elevated psychological distress. AI-DBT was developed and refined through prior funded studies and delivers brief DBT skills videos combined with coaching via a multilingual, constrained-logic conversational agent accessible by phone or text. In a pilot randomized controlled trial (n=80), participants with serious illness and psychological distress will be randomized to usual care or usual care plus AI-DBT.
Aim 1 will assess feasibility and acceptability using recruitment, retention, engagement metrics, participant-reported satisfaction, and qualitative interviews. Aim 2 will examine preliminary efficacy on the mechanistic target of self-efficacy to manage emotions and exploratory clinical outcomes including psychological distress, anxiety, depression, and quality of life.This study will generate critical early-stage data to support a future R01 and advance scalable, mechanism-driven psychosocial care for people living with serious illness.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control | No intervention | –Usual Care Control Condition: Participants randomized to the usual care condition will continue to receive all medical and psychosocial services routinely available to them through their existing care teams (e.g., primary care, oncology, cardiology, nephrology, palliative care, social work). Variation in usual care across clinical contexts is an expected and intentional feature of this study. AI-DBT is designed as an additive intervention that can be layered onto existing care, regardless of diagnosis or setting. |
| intervention | Experimental | Behavioral: AI DBTThe 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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- -
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 DBTThe 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. | Behavioural | intervention |
Primary outcome
Acceptability
Time frame: 8 weeks
Acceptability will be measured quantitatively using the Acceptability of Intervention Measure and Intervention Appropriateness Measure
Feasibility
Time frame: 8 weeks
Feasibility is defined by the number of unique videos watched. If a participant watches 9 or more of the 14 videos, engagement will be achieved.
Preliminary efficacy
Time frame: 8 weeks
DBT ways of Coping Checklist
3 secondary outcomes
depressive symptoms
Time frame: 8 weeks
anxiety
Time frame: 8 weeks
psychological distress
Time frame: 8 weeks
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 5 Aug 2026.
- Individual participant dataSharing planned: Yes. patient demographics, clinical characteristics, analysis code, qualitative interviews will all be shared with the Ascent deidentified data repository at the University of Colorado.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AI DBT in people with Serious Illness and Distress, Emotional, run by Rutgers, The State University of New Jersey.
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 0 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: opening soon, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 ((914) 861-5158, khanjj@sph.rutgers.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability (time frame: 8 weeks). The study lists 3 primary outcomes in all. 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 5 Aug 2026.