An interventional study of Ash and Psychoeducation in Depressive Disorder and Depressive Symptoms, sponsored by Slingshot AI. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-05.
Sponsored by Slingshot AI · Not applicable, Interventional, and Treatment
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:
Researchers will compare two groups to see if Ash works as well as therapy:
Participants will:
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.
855 studies on the registry are indexed under Depressive Disorder; 159 are open to participants now.
This study's planned enrollment of 500 is above the median of 88 across 689 interventional studies indexed under Depressive Disorder.
Browse Depressive Disorder studies →This is the only study on the registry with Slingshot AI as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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: Psychoeducation
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.
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.
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.
Time frame: Baseline (Week 0) and Week 4
Change in Anxiety Symptoms (GAD-7)
Change in Generalized Anxiety Disorder 7-item scale (GAD-7) total score from baseline to Week 4, estimated as the between-arm difference and within-arm change, with trajectory estimates across all timepoints (Weeks 2, 4, 8, and 36).
Time frame: Baseline (Week 0), Week 2, Week 4, Week 8, and Week 36
Change in Functional Impairment (WPAI-GH)
Change in Work Productivity and Activity Impairment Questionnaire: General Health (WPAI-GH) from baseline to Week 4, estimated as the between-arm difference and within-arm change, with trajectory estimates across all timepoints (Weeks 2, 4, 8, and 36).
Time frame: Baseline (Week 0), Week 2, Week 4, Week 8, and Week 36
Change in Global Physical Health (PROMIS Global Health)
Change in PROMIS Global Health Global Physical Health (GPH) T-score from baseline to Week 4, estimated as the between-arm difference and within-arm change, with trajectory estimates across all timepoints (Weeks 2, 4, 8, and 36). Higher T-scores indicate better physical health.
Time frame: Baseline (Week 0), Week 2, Week 4, Week 8, and Week 36
Change in Global Mental Health (PROMIS Global Health)
Change in PROMIS Global Health Global Mental Health (GMH) T-score from baseline to Week 4, estimated as the between-arm difference and within-arm change, with trajectory estimates across all timepoints (Weeks 2, 4, 8, and 36). Higher T-scores indicate better mental health.
Time frame: Baseline (Week 0), Week 2, Week 4, Week 8, and Week 36
Change in Sleep Quality (SQS)
Change in Sleep Quality Scale (SQS) score from baseline to Week 4, estimated as the between-arm difference and within-arm change, with trajectory estimates across all timepoints (Weeks 2, 4, 8, and 36).
Time frame: Baseline (Week 0), Week 2, Week 4, Week 8, and Week 36
Change in Behavioral Activation (BADS-AC)
Change in Behavioral Activation for Depression Scale - Activation subscale (BADS-AC) score from baseline to Week 4, estimated as the between-arm difference and within-arm change, with trajectory estimates across all timepoints (Weeks 2, 4, 8, and 36). Higher scores indicate greater behavioral activation.
Time frame: Baseline (Week 0), Week 2, Week 4, Week 8, and Week 36
Change in Perceived Stress (PSS-4)
Change in 4-item Perceived Stress Scale (PSS-4) score from baseline to Week 4, estimated as the between-arm difference and within-arm change, with trajectory estimates across all timepoints (Weeks 2, 4, 8, and 36). Higher scores indicate greater perceived stress.
Time frame: Baseline (Week 0), Week 2, Week 4, Week 8, and Week 36
Change in Worry (PSWQ-3)
Change in 3-item Penn State Worry Questionnaire (PSWQ-3) score from baseline to Week 4, estimated as the between-arm difference and within-arm change, with trajectory estimates across all timepoints (Weeks 2, 4, 8, and 36). Higher scores indicate greater worry.
Time frame: Baseline (Week 0), Week 2, Week 4, Week 8, and Week 36
Change in Posttraumatic Stress Symptoms (PC-PTSD-5)
Change in Primary Care PTSD Screen for DSM-5 (PC-PTSD-5) score from baseline to Week 6, estimated as the between-arm difference and within-arm change, with trajectory estimates across all timepoints (Weeks 2, 4, 8, and 36). Higher scores indicate greater posttraumatic stress symptoms.
Time frame: Baseline (Week 0), Week 2, Week 4, Week 8, and Week 36
Plan to share: No — De-identified analytic datasets are stored in access-controlled systems and are not made publicly available. No external collaborators are currently planned for this pilot study; if external collaborators are added in the future, data sharing would occur only under a Data Use Agreement executed prior to any transfer. Data are collected and analyzed by the Slingshot AI research team under the PI's supervision, using only de-identified, study-identifier-linked records (direct identifiers are stored separately in an access-controlled operational system). Any future use of the data outside the general scope of evaluating the effectiveness, safety, and engagement of Ash, including sharing with external parties, will be submitted to the IRB (BRANY) as a protocol amendment or new submission, as appropriate.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.