AI Mental Health Tool vs. Psychoeducation Control

Slingshot AI is the developer of Ash, a conversational AI mental health tool designed to provide accessible, evidence-informed support for adults experiencing common mental health concerns such as low mood, anxiety, stress, and sleep difficulties. Common mental health concerns are highly prevalent in the United States, and access to traditional psychotherapy remains constrained by cost, geography, and clinician supply. A central open question is how much of any observed benefit from a tool like Ash is attributable to its personalized, conversational, and adaptive properties, as opposed to the psychoeducational content and the structure, cadence, and expectancy that any well-designed digital program provides. Psychoeducation alone has documented effects on depressive symptoms, so a psychoeducational comparator delivered in the same interface, at the same cadence, and with the same reminder schedule isolates the contribution of personalized conversational support.

This protocol establishes a pilot, two-arm, parallel-group, open-label, superiority randomized controlled trial comparing two conditions over a 4-week period in adults with moderate or higher symptoms of depression (PHQ-9 total score >= 10 at screening): full access to Ash, including conversational chat, memory, and personalized content; and a psychoeducational control consisting of 12 static psychoeducational modules released three times per week within the same Ash application, without conversational chat or personalization. Participants randomized to the Ash arm receive 9 months of free Ash access beginning at randomization. Participants randomized to the Psychoeducation arm receive the 12 modules over the first 4 weeks, with Ash conversational chat deferred until after the Week 4 primary endpoint, at which point their 9 months of free Ash access begins. Both arms receive an identical cadence of reminders and notifications. This deferral preserves a clean comparison of personalized conversational support versus static psychoeducational content during the intervention window while ensuring that every participant ultimately receives the same study benefit.

Target enrollment is approximately 500 adults, randomized 1:1 to Ash (approximately 250) and Psychoeducation (approximately 250). The SAP pre-specifies a blinded sample size re-estimation at a fixed interim, based on pooled (arm-blinded) variance and observed retention. Eligible participants are new Ash users with active accounts, aged 18 or older, residents of the United States, English-speaking, and able to provide informed consent, among other eligibility criteria; individuals currently engaged in individual therapy or higher-level mental health treatment, and those with severe psychiatric presentations (e.g., positive mania screen, positive psychosis screen, frequent heavy substance use, suicidality, or recent psychiatric medication changes), are excluded.

Primary aim: Evaluate whether Ash produces greater reduction in depressive symptoms (PHQ-9) than the psychoeducational control from baseline (Week 0) to Week 4. The between-arm difference in PHQ-9 change (Ash vs. Psychoeducation) will be estimated with a two-sided 95% confidence interval and tested for superiority at a two-sided alpha of 0.05 in the intention-to-treat population, as pre-specified in the preregistration and statistical analysis plan (SAP). Within-arm change from baseline to Week 4 will also be estimated for each arm.

Secondary aims: Estimate within-arm change and the between-arm difference in anxiety symptoms (GAD-7), functional impairment (WPAI-GH), global health (PROMIS Global Health), sleep quality (SQS), behavioral activation (BADS-AC), perceived stress (PSS-4), worry (PSWQ-3), and PTSD symptoms (PC-PTSD-5); and evaluate the feasibility of recruitment, in-app consent, randomization, retention, survey completion, and psychoeducational module engagement to inform the design and powering of a future definitive trial.

Exploratory aims: Characterize therapeutic alliance with Ash (WAI-3) among participants during periods of active Ash access and its association with symptom change; characterize healthcare utilization, chronic-condition self-management, social support, and concomitant care initiation across arms; and explore additional candidate mechanisms of change (worry, behavioral activation, perceived stress) by examining whether changes in these processes are associated with changes in clinical outcomes.

All study onboarding (recruitment prompt, informed consent, and baseline screening/assessment survey) occurs in-app, and randomization occurs automatically when an eligible respondent submits the baseline survey. The psychoeducational modules are delivered within the Ash application on participants' own devices; no separate platform, account, or download is required. Follow-up surveys are administered remotely via a secure survey platform (Typeform) at Weeks 2, 4, 8, and 36. No in-person procedures occur. This research does not involve FDA-regulated drugs or devices.

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.