AI Mental Health Tool vs. Psychoeducation Control

NCT07841483 | Active Not Recruiting

• 1 other identifier: SL2026-003
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Depressive Disorder; Depressive Symptoms

Keywords

Artificial Intelligence; AI Mental Health; Digital Mental Health; Conversational AI; Telehealth; PHQ-9; Mental Health Chatbot; Digital Therapeutics; Behavioral Health

Outcome Measures

Primary Outcomes (1)

• Change in Depressive Symptoms (PHQ-9)

  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.

  Baseline (Week 0) and Week 6

Secondary Outcomes (9)

• Change in Anxiety Symptoms (GAD-7)

  Baseline (Week 0), Week 2, Week 6, Week 10, and Week 36

• Change in Functional Impairment (WPAI-GH)

  Baseline (Week 0), Week 2, Week 6, Week 10, and Week 36

• Change in Global Physical Health (PROMIS Global Health)

  Baseline (Week 0), Week 2, Week 6, Week 10, and Week 36

• Change in Global Mental Health (PROMIS Global Health)

  Baseline (Week 0), Week 2, Week 6, Week 10, and Week 36

• Change in Sleep Quality (SQS)

  Baseline (Week 0), Week 2, Week 6, Week 10, and Week 36

Study Arms (2)

Ash (AI Mental Health Tool)

EXPERIMENTAL

Participants receive free access to Ash, a conversational AI mental health tool, beginning at randomization and continuing for 9 months. Ash use is not directed or restricted during the study; participants may use Ash freely.

Behavioral: Ash

Psychoeducation

ACTIVE COMPARATOR

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.

Behavioral: Brief Therapist-Delivered Telehealth

Interventions

Ash BEHAVIORAL

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.

Ash (AI Mental Health Tool)

Brief Therapist-Delivered Telehealth BEHAVIORAL

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.

Psychoeducation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Slingshot AI: lead

Study Sites (1)

Slingshot AI

New York, New York, 10013, United States

Location

MeSH Terms

Conditions

Depressive Disorder; Depression

Condition Hierarchy (Ancestors)

Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Caitlin Stamatis, PhD

  Slingshot AI

  PRINCIPAL INVESTIGATOR

• Derrick Hull, PhD

  Slingshot AI

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2026
• First Posted: September 25, 2026
• Study Start: September 11, 2026
• Primary Completion: October 1, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: September 25, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)