Radically different
Background: Generative artificial intelligence (GenAI) chatbots have the potential to provide personalized mental health support to individuals at scale. Objective: This study evaluates the feasibility and usage patterns of the Safespace GenAI chatbot, an artificial intelligence (AI)–driven smartphone app that offers a large language model–powered interactive chatbot to support mental health. Methods: Using a mixed methods approach, we explored baseline attitudes toward GenAI chatbots and chatbot usage patterns, conducted a qualitative content analysis of participants’ experiences, and descriptively assessed patterns related to preintervention depressive symptoms. The study included an initial sample of 42 university students, 20 of whom actively used the chatbot over 2 to 4 weeks, generating 286 user-chatbot interactions. Results: Preintervention surveys indicated that the majority of participants anticipated that the chatbot would be helpful (27/42, 64%) and that they trusted its privacy safeguards (39/42, 93%). Usage patterns suggested that the highest levels of interaction occurred early in the morning and late at night, when peer and professional support may be inaccessible. The qualitative analysis indicated that participants appreciated using the chatbot for reflection as a blended-care tool between their counseling sessions, while also naming technical barriers and specific design needs required to sustain engagement. In addition, our exploratory analyses descriptively showed that participants with elevated depression scores engaged in emotional disclosure during 99% (38 sessions with 8 participants) of their sessions, compared to 84% (26 sessions of 12 participants) of those with low symptoms. Due to the small sample size, future adequately powered studies are needed to inferentially examine these observed patterns. Conclusions: These findings provide initial insights into the usage and engagement dynamics of the Safespace GenAI chatbot and highlight directions for future research to optimize GenAI-driven mental health interventions. Trial Registration: AEA Registry AEARCTR-0013291; https://doi.org/10.1257/rct.13291-1.0
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The world’s first in-human embryonic stem cell-derived clinical trial for Huntington’s disease has launched at UCI Health, the clinical arm of the University of California, Irvine. The Phase Ib/IIa trial will evaluate the safety of hNSC-01 neural stem cells derived from embryonic stem cells delivered to the brain by a specialized neurological mapping and targeting stereotactic system.
Huntington’s disease is a fatal, progressive genetic disorder that gradually destroys brain cells. It usually begins between the ages of 35 and 50 with symptoms that include involuntary movements, difficulty thinking and planning daily tasks, and mood changes such as depression. If successful, this therapy could prolong independent living and significantly reduce long-term care costs.
“This clinical trial highlights the important role that an interdisciplinary academic and clinical team together with the HD families, plays in advancing medicine,” said Leslie M. Thompson, PhD, professor of psychiatry and human behavior at UC Irvine. “We are grateful to our patients and their incredible families for their bravery to provide hope for others with very few options.”
The first patient received the intervention at UCI Health Irvine (home to Orange County’s first adult bone marrow/stem cell transplant and cellular therapy program) in May. A second patient is scheduled to receive the intervention in July.
“The first patient intervention went very well. To date, they haven’t reported any serious adverse events,” said Ravi Rajmohan, MD, UCI Health neurologist. “This trial may help us move one step closer to a future with available treatments that could potentially slow the progression of Huntington’s disease.”
The therapy, hNSC-01, uses pluripotent neural stem cells derived from embryonic stem cells, which were manufactured through the UC Davis GMP facility. In animal studies, the cells have been shown to protect existing brain cells, replace lost cells, rebuild impaired brain circuits, release helpful proteins, such as brain-derived neurotrophic factor (BDNF), and reduce harmful protein accumulations that damage brain cells. The stem cells were also shown to be safe over long periods in mice.
The clinical trial will enroll 21 people ages 18 to 65 with early-stage Huntington’s disease. Twelve participants will be enrolled into a Phase Ib dose-escalation group and nine in a Phase IIa expansion group.
The stem cells are implanted during a roughly six-hour surgical procedure done under general anesthesia. While lying face down in an MRI scanner, the patient receives stem cells implanted directly into the striatum deep in the brain, using a purchased proprietary therapy-enabling platform for navigation and surgical delivery. Damage to the striatum, which is responsible for motor control, decision-making, motivation and more, causes Huntington’s disease symptoms. Subjects will be closely monitored for safety as well as preliminary signs of potential benefit.
The clinical trial is made possible by a $12 million grant from the California Institute of Regenerative Medicine (CIRM), and the trial is coordinated through the UC Irvine Alpha Clinic.
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