Mental health chatbots

Chatbots and conversational AI apps that deliver cognitive behavioral therapy exercises and emotional support, or take self-referrals and intake information for psychological therapy services.

4 tools · Reviewed · How we grade

Two overlapping chat bubbles, one blue with typing dots and one white holding an amber leaf above a gentle wave.
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These tools hold text conversations with patients or the public, deliver cognitive behavioral therapy exercises, or take self-referrals for therapy services. FDA's briefing for a November 2025 advisory committee said the agency had authorized fewer than 20 digital mental health devices, none of them AI-enabled, and listed software that helps patients maintain behavioral coping skills as an example of a function under enforcement discretion. A 2023 meta-analysis of 15 randomized trials found that AI conversational agents reduced symptoms of depression (Hedges' g 0.64) and distress but not overall psychological well-being.

States have begun to legislate, according to a 2026 analysis of statutes. Illinois's Wellness and Oversight for Psychological Resources Act, enacted in August 2025, restricts licensed clinicians' use of AI in diagnosis, treatment planning and therapeutic communication but excludes physicians. Nevada's AB406, in effect since July 2025, bars AI providers from offering tools that would deliver mental health care. Utah's HB452, in effect since May 2025, requires mental health chatbots to provide clear disclosure and bans the sale of identifiable health data, and a New York law in effect since November 2025 requires operators of AI companions to refer users to care when they detect suicidal thoughts.

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Grade DLittle or no independent evidence

Ash

Slingshot AI

Consumer conversational AI for mental health support, built on a psychology foundation model trained on psychotherapy data.

FDA: not cleared or approved for the use graded
Cost: Ash's App Store listing, with Slingshot AI as seller, shows the app as free to download with in-app purchases labeled Unlimited access priced from $9.99 to $169.99, without saying what each one covers.

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Ash is a consumer chat app for mental health support. Company researchers write that it runs on a foundation model pretrained on deidentified psychotherapy data, with a separate classifier that detects suicide and self-harm risk and surfaces crisis resources. A Slingshot psychologist described it to an FDA advisory committee as an app that supports users with stress and relationship challenges.

Why this grade. The only outcome-related evidence is a company preprint on safety benchmarks and an audit of 20,000 user conversations. A company-sponsored randomized trial against psychoeducation began in September 2026 and has no results. No independent accuracy or outcome study was found.

The evidence

In the preprint, with four of six authors from Slingshot AI, the Ash model without its safety classifier produced harmful responses to 0.4% of self-harm and suicide prompts, 8.4% of eating disorder prompts and 9.9% of substance use prompts, against 12% to 58% for three GPT-5 models. In 20,000 sampled conversations from September and December 2025, clinicians reviewed sessions flagged by a language model; crisis resources were missing in three of 80 confirmed self-harm or suicide sessions the classifier had missed, all involving self-injury.

In a 2026 evaluation of crisis features in six apps, by two authors affiliated with Elomia Health, Ash scored 25.0 of 65 points, in the poor range. The registered trial plans to enroll about 500 new users with at least moderate depressive symptoms.

FDA
No FDA clearance or authorization was found. At an FDA advisory committee meeting in November 2025, a Slingshot AI speaker argued that generative AI wellness products can remain low risk under current guidance; FDA's briefing document said no AI-enabled device had been authorized for mental health uses.
Randomized trial
None published
Key study
Research Square preprint, 2026, company safety benchmarks and audit of 20,000 user conversations
Limits
All outcome-related data come from the company, as a preprint, and measure safety behavior rather than symptoms or clinical outcomes. Clinicians reviewed only a triaged subset of conversations, so the miss rate is a lower bound. The crisis-feature rating used a new instrument, applied by its own developers.
Cost
Ash's App Store listing, with Slingshot AI as seller, shows the app as free to download with in-app purchases labeled Unlimited access priced from $9.99 to $169.99, without saying what each one covers. checked
Specialties
Psychiatry
Checked against its sources
Grade BEvidence from clinical use · grade for Limbic Access

Limbic Access

Limbic

Self-referral chatbot for NHS Talking Therapies that gathers symptoms and risk and sends clinicians a structured referral report.

FDA: not cleared or approved for the use graded
Cost: A July 2025 NICE resource impact report puts Limbic Access at £4.20 to £6.59 per referral, including VAT, with the price per referral falling as referral volume rises.

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Limbic Access sits on a mental health service's website as a chatbot through which patients self-refer. It uses machine learning to infer likely diagnoses, selects extra symptom questionnaires, flags risk and sends a structured referral report into the electronic health record before the clinician's assessment, according to a company-authored study. Limbic Care is a separate generative AI therapy app.

Why this grade. Large observational studies in NHS Talking Therapies measured its effect on care: services using it had more referrals, especially from minority groups, and assessments took 12.7 minutes less. No randomized trial of Limbic Access was found; company staff wrote the studies.

The evidence

In nine services with 64,862 patients, assessments of patients referred through Limbic Access averaged 41.6 minutes against 54.4 minutes, waits for assessment were 2.2 days shorter, and reliable recovery was 58% against 27.4%. In a study of 129,400 patients, referrals rose 15% at services using the chatbot against 6% at control services, including 179% among nonbinary and 29% among ethnic minority patients. An independent early value assessment for NICE found the evidence non-comparative in the main and identified no information on quality and accuracy.

In a survey of 131 practitioners, clinicians reported higher wellbeing and lower cognitive load for assessments with Limbic reports. In a randomized trial of 540 U.S. adults recruited online, the Limbic Care app increased engagement 2.4 times over digital workbooks, with comparable anxiety and depression outcomes.

Used by
A company-authored analysis included 64,862 patients at nine NHS Talking Therapies services in England, and a multisite study covered 129,400 patients.
FDA
No FDA clearance or authorization was found. A company-authored 2026 study describes Limbic Access as a UK CE-marked Class IIa medical device; no source in PubMed confirmed UKCA marking. A company-authored 2026 study describes Limbic Access as a UK CE-marked Class IIa medical device.
Randomized trial
None published
Key study
Nature Medicine, 2024, multisite observational study, 129,400 patients
Limits
Patients chose their referral route, so case mix may differ, and the recovery comparison is observational. Limbic staff developed the product and wrote the studies; the NICE assessment found most evidence non-comparative and company data hard to assess. The clinician survey used bespoke scales and self-report.
Cost
A July 2025 NICE resource impact report puts Limbic Access at £4.20 to £6.59 per referral, including VAT, with the price per referral falling as referral volume rises. checked
Specialties
Psychiatry
Checked against its sources
Grade BEvidence from clinical use

Woebot

Woebot Health · WB001; W-GenZD; W-SUDs

Text-based chatbot for cognitive behavioral therapy whose trials are widely cited; the consumer app was withdrawn in June 2025.

FDA: not cleared or approved for the use graded
Cost: Woebot Labs described the app as free when it launched on iOS in 2018, and the company says the app was retired on June 30, 2025.

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Woebot was a smartphone chatbot, which its makers call a relational agent, that guided users through brief text conversations drawing on cognitive behavioral therapy, interpersonal therapy and mood tracking. Company authors describe WB001, a version for postpartum depression; versions for adolescents and for substance use were tested in trials.

Why this grade. Randomized trials are mixed. In a hospital postpartum trial of 192 women, one of two primary depression measures improved; in an adolescent clinic trial, Woebot was noninferior to group therapy; and a substance use trial found no difference from psychoeducation.

The evidence

In the first randomized trial, 70 students recruited online used Woebot or read an ebook for two weeks; depression scores fell only with Woebot. In the postpartum trial, women were enrolled before discharge at a Stanford hospital; PHQ-9 scores fell 1.32 points with the chatbot against 0.13 with usual care, but Edinburgh Postnatal Depression Scale scores did not differ, and baseline scores were below screening thresholds.

Among 141 adolescents seeking treatment at a children's hospital, the app was noninferior to telehealth group therapy on depression at four weeks, a secondary aim. For substance use, the app cut use occasions more than a waiting list in 180 adults, but not more than emailed psychoeducation in 258 adults. Woebot Health staff were authors on these trials. In an independent trial of 105 adults with tinnitus recruited online, Woebot and a tinnitus chatbot both improved anxiety and depression more than a waiting list.

Used by
A company analysis included 36,070 adults who used the app between November 2019 and August 2020. The app was withdrawn from public use in June 2025, according to an independent 2026 trial report.
FDA
No FDA clearance or authorization was found. Company authors wrote that FDA granted Breakthrough Device Designation to WB001 for postpartum depression; the adolescent version tested in a 2025 trial was described as an investigational device. Company authors report FDA Breakthrough Device Designation for WB001, the postpartum depression version; the adolescent version tested in a 2025 trial was described as an investigational device.
Randomized trial
Yes. Randomized trials in 70 students against an ebook (JMIR Mental Health, 2017), 192 postpartum women at a Stanford hospital (AJOG Global Reports, 2023), 141 adolescents against group therapy (JAACAP Open, 2025) and 258 adults with substance use against psychoeducation (Journal of Substance Use and Addiction Treatment, 2026). The review also describes waiting-list controlled trials in 180 adults with substance use (Drug and Alcohol Dependence, 2021) and 105 adults with tinnitus (Internet Interventions, 2026).
Key study
Journal of Substance Use and Addiction Treatment, 2026, randomized trial against emailed psychoeducation, 258 adults
Limits
Most trials were short, unblinded and recruited online or enrolled people without clinical depression; the adolescent trial's primary aim was feasibility. Company staff coauthored all but one trial. No Woebot product has FDA authorization, and the adolescent and substance use versions were investigational.
Cost
Woebot Labs described the app as free when it launched on iOS in 2018, and the company says the app was retired on June 30, 2025. checked
Specialties
Pediatrics, Psychiatry, Obstetrics and gynecology
Checked against its sources
Grade BEvidence from clinical use

Wysa

Chatbot app that delivers cognitive behavioral therapy exercises, mindfulness and sleep tools, with optional human counselors.

FDA: not cleared or approved for the use graded
Cost: Wysa says talking to its AI is free, with premium tools and human coaching at prices its site does not list, and a July 2025 NICE report puts its NHS referral assistant at £1.39 to £3.90 per referral plus a one-time £10,180 setup cost per service, including VAT.

Full reviewHide full review: Wysa

Wysa is a smartphone app whose chatbot delivers cognitive behavioral therapy, dialectical behavioral therapy, mindfulness and sleep tools; a 2025 trial protocol describes it as combining rule-based decisions, natural language understanding and large language models. Some versions add text access to human counselors, and a chronic pain version adds behavioral activation and pain acceptance content.

Why this grade. Two randomized trials disagree. In 68 adults with arthritis or diabetes recruited online, depression and anxiety fell with Wysa and not with no intervention, but in an NHS trial of 76 patients awaiting Talking Therapies, the primary outcome, change in depression, was similar in both arms. Neither establishes a consistent benefit in routine care.

The evidence

In the NHS trial, 2,161 patients were screened and 76 randomized 2:1 to Wysa or a control arm; 30 were lost to follow-up, and the authors concluded there was no evidence that Wysa treats depression. Two of its nine authors listed Wysa affiliations. In the online trial, with 34 participants per arm over four weeks, stress did not change in either group.

At an academic orthopedic clinic, 51 patients with elevated depression or anxiety scores given Wysa improved more on depression, pain interference and physical function scores at two months than 51 patients in usual care, in a retrospective, nonrandomized comparison. An earlier company analysis of app users compared frequent with infrequent users. An independent review for NICE found the evidence for Wysa's NHS referral assistant less robust than that for Limbic Access.

Used by
The 2025 protocol describes Wysa as having more than 6.5 million users, with some versions covered by employers and insurers. Central and Northwest London NHS Foundation Trust offered it to patients waiting for Talking Therapies in a randomized trial.
FDA
No FDA clearance or authorization was found. A 2025 narrative review says Wysa "received FDA breakthrough device approval" for chronic pain and anxiety and calls it FDA approved; breakthrough status is a designation, not a marketing authorization, and FDA's briefing document for a November 2025 advisory committee said no AI-enabled device had been authorized for mental health uses. A 2025 narrative review says Wysa received FDA breakthrough device approval for chronic pain and anxiety; breakthrough status is a designation, not a marketing authorization.
Randomized trial
Yes. Two randomized trials: 68 adults with arthritis or diabetes recruited online (JMIR Formative Research, 2024) and 76 patients awaiting NHS Talking Therapies (International Journal of Social Psychiatry, 2026).
Key study
International Journal of Social Psychiatry, 2026, randomized trial, 76 patients awaiting NHS Talking Therapies
Limits
The randomized trials were small and short, participants knew their assignment, with heavy loss to follow-up in the NHS trial; most other studies are uncontrolled, compare high with low users, or have Wysa employees as authors. A 2026 rating of crisis features in six apps by authors affiliated with another AI mental health company scored Wysa highest but still short of good.
Cost
Wysa says talking to its AI is free, with premium tools and human coaching at prices its site does not list, and a July 2025 NICE report puts its NHS referral assistant at £1.39 to £3.90 per referral plus a one-time £10,180 setup cost per service, including VAT. checked
Specialties
Psychiatry, Orthopedic surgery
Checked against its sources

Reviews of the published evidence, not medical advice or an endorsement of any product.