AI Mental Health Tool vs. Psychoeducation Control

NCT07841483 · tracked via the Priya Life Science USA tracker

Sponsor

Slingshot AI

Phase

Not applicable

Started

2026-09-11

Last updated

2026-11-05

Condition(s) studied

Depressive DisorderDepressive Symptoms

Investigational drug(s) / intervention(s)

AshPsychoeducation

Ash: Ash is a conversational AI mental health tool accessed via mobile and web applications on participants' personal devices. It provides accessible, evidence-informed support for common mental health concerns such as low mood, anxiety, stress, and sleep difficulties. Participants in this arm receive free access to Ash beginning at randomization and continuing for 6 months; use is self-directed and not restricted.

Psychoeducation: Participants receive installments of the NIMH Depression Booklet, split into 12 sections over the course of 4 weeks following randomization. Ash chatting remains locked for this arm during the 4-week intervention window. Free access to Ash for 9 months begins after the week 4 primary-endpoint window.

Study summary

The goal of this clinical trial is to learn if Ash, an AI chat tool for mental health, works better than static psychoedcuation in reducing mental health symptoms. Participants must be new users to the Ash app and have at least moderate symptoms of depression. The main questions it aims to answer are:

* Does using Ash for 4 weeks lower depression symptoms more than 4 weeks of regularly presented psychoeducation?
* Does using Ash change anxiety, sleep, stress, and other symptoms more than psychoeducation?

Researchers will compare two groups to see if Ash works as well as therapy:

* One group will get free access to Ash right away.
* The other group will get 4 weeks of regularly presented psychoeducation, then get free access to Ash afterward.

Participants will:

* Fill out an online survey about their symptoms at the start of the study
* Use Ash or receive psychoeducation, depending on their group
* Fill out follow-up surveys about their symptoms and well-being at 2, 4, 8, and 36 weeks
* Complete all study activities online; no in-person visits are required

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * Adults aged 18 years or older * Residents of the United States * New Ash users with active accounts at the time of recruitment * English-speaking * Able to provide informed consent * At screening: PHQ-9 total score \>= 10 (indicating at least moderate depressive symptoms) * During onboarding, indicated that they are willing to share their data and are interested in being contacted about and participating in research Exclusion Criteria: * Currently engaged in individual therapy or counseling * ASRM total score \>= 6 at screening (positive screen for mania) * PRIME-5 positive at screening, defined as \>= 1 item rated 6 (Definitely Agree) OR \>= 3 items rated 5 (Somewhat Agree) (positive screen for psychosis-spectrum symptoms) * Self-reported heavy episodic drinking at a frequency of weekly or more often on the NIAAA single-item alcohol screen (past 12 months) * Self-reported nonmedical drug use at a frequency of weekly or more often on the NIDA single-item substance use screen (past 12 months) * Any change to psychiatric medications in the 6 weeks prior to screening (any response other than "No changes to my meds in the past 6 weeks") * Currently in inpatient, residential, intensive outpatient (IOP), or partial hospitalization (PHP) mental health treatment * Suicidality - PHQ-9 item 9 score of 3 Special Populations: No minors are enrolled. Adults unable to consent are not enrolled. Pregnant women are not excluded. Prisoners are not targeted; the recruitment channel (an in-app prompt to consenting adult Ash users) is not anticipated to reach incarcerated populations, and prisoners will not be knowingly enrolled.

Primary outcome measure(s)

Change in Depressive Symptoms (PHQ-9) — Baseline (Week 0) and Week 4
Change in Patient Health Questionnaire-9 (PHQ-9) total score from baseline to Week 6, evaluated as the between-arm difference (Ash vs. Therapy) against a pre-specified non-inferiority margin. PHQ-9 total scores range from 0 to 27, with higher scores indicating more severe depressive symptoms.

Trial sites (1)

Facility	City	Region	Status
Slingshot AI	New York	New York

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Neurotechnology Following Traumatic Brain Injury Active, not recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07841483 on ClinicalTrials.gov ↗ ← All trials in the USA