Digital Enablement of Psychedelic-Assisted Therapy in Non-Clinical Settings: A Systematic Review of Safety, Efficacy, and Implementation Models
Brendan Driscoll, Shaheen E. Lakhan
Psychoactives December 24, 2025 DOI: 10.3390/psychoactives4040035 (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Systematic review Qualitative Peer reviewed |
|---|---|
| Sample size | 12,731 |
| Population | Participants in studies of digitally enabled at-home psychedelic-assisted therapy |
| Interventions | Ketamine Esketamine Ayahuasca |
| Topics | Esketamine Psychedelic-assisted therapy |
| Keywords | Digital health Telemedicine Remote monitoring At-home ketamine |
| Citations | 1 |
| Key findings | Digitally enabled at-home psychedelic therapy shows high response rates for depression and rapid symptom improvement, but serious safety concerns and low methodological rigor limit confidence in the findings. |
Abstract
Psychedelic-assisted therapy offers rapid and profound benefits for treatment-resistant psychiatric conditions but remains constrained by the need for intensive, clinic-based administration. Concurrently, advances in digital health technologies have introduced scalable tools. This systematic review evaluates the safety, efficacy, and implementation of digitally enabled psychedelic-assisted therapy delivered in non-clinical settings. A comprehensive search of five databases, registered in PROSPERO (CRD420251020968) and conducted in accordance with PRISMA guidelines, identified six eligible studies including real-world analyses, clinical trials, qualitative research, and case reports, representing a total of 12,731 participants. Most studies examined at-home ketamine or esketamine therapy supported by telehealth platforms or mobile applications. Data were synthesized narratively given the heterogeneity of designs and outcomes. Digital enablement was associated with high response rates (ranging from 56.4% to 62.8% for depression) and rapid symptom improvement, particularly in depression and anxiety. Remote monitoring and digital tools demonstrated feasibility and acceptability, but serious safety concerns—including psychiatric adverse events and one unintentional overdose—underscore the need for strict oversight. Risk of bias was moderate to serious across non-randomized studies, limiting confidence in the findings. One study on virtual ayahuasca rituals highlighted the sociocultural potential and limitations of online practices. Despite promising preliminary findings, the field is marked by low methodological rigor and absence of controlled trials. Digitally supported at-home psychedelic therapy represents a transformative but high-stakes frontier, requiring robust research and safeguards to ensure safe, equitable, and effective implementation. No funding was received for this review, and the authors declare no conflicts of interest.
Comparable studies
Other systematic reviews and meta-analyses on psychedelic-assisted therapy, most cited first.
| Study | Year | Design | Participants |
|---|---|---|---|
| A Meta-Analysis of Placebo-Controlled Trials of Psychedelic-Assisted Therapy | 2020 | Systematic review | |
| Psychedelic-Assisted Psychotherapy—A Systematic Review of Associated Psychological Interventions | 2022 | Systematic review | |
| Psychedelic therapy for depressive symptoms: A systematic review and meta-analysis. Participants in studies of psychedelic therapy for depressive symptoms (Major... | 2023 | Systematic review with meta-analysis | n = 14 |
| Psilocybin-assisted therapy for depression: A systematic review and meta-analysis. Patients diagnosed with life-threatening illnesses or major depressive disorder | 2023 | Systematic review and meta-analysis | n = 686 |
| Treating posttraumatic stress disorder with MDMA-assisted psychotherapy: A preliminary meta-analysis and comparison to prolonged exposure therapy Patients with PTSD | 2016 | Meta-analysis |
Citations in the library
Cites 11
- Single-Dose Psilocybin for a Treatment-Resistant Episode of Major Depression. New England Journal of Medicine November 3, 2022
- Global Street Food: la cocina de la calle Diseño interior 2009
- A Consensus Statement on the Use of Ketamine in the Treatment of Mood Disorders JAMA Psychiatry March 1, 2017
- Psychedelic-Assisted Psychotherapy: A Paradigm Shift in Psychiatric Research and Development Frontiers in Pharmacology July 5, 2018
- At-home, sublingual ketamine telehealth is a safe and effective treatment for moderate to severe anxiety and depression: Findings from a large, prospective, open-label effectiveness trial. Journal of Affective Disorders July 1, 2022
and 6 more in the library