Accepted for/Published in: Journal of Medical Internet Research
Date Submitted: Nov 28, 2024
Date Accepted: Mar 7, 2025
Date Submitted to PubMed: Mar 28, 2025
Combining AI and Human Support in Mental Health: a Digital Intervention with Comparable Effectiveness to Human-delivered Care
ABSTRACT
Background:
Escalating global mental health demand exceeds existing clinical capacity. Scalable digital solutions will be essential to expand access to high-quality mental healthcare for everyone. This study evaluated a structured, evidence-based digital program for mild, moderate and severe anxiety that combined an Artificial Intelligence (AI) driven conversational agent to deliver content with human clinical oversight and user support to maximize outcomes.
Objective:
This study aimed to measure engagement, clinical effectiveness, acceptability and safety of this digital intervention in comparison to externally generated comparator groups.
Methods:
All prospective participants (N=299) were given the digital intervention to use for up to 9 weeks. Endpoints for effectiveness, engagement, acceptability, and safety were collected before, during and after the intervention, and at one-month follow-up. Adherence and effectiveness were compared to three propensity-matched real-world patient comparator groups: i) waiting control; ii) face-to-face cognitive behavioral therapy (CBT); and iii) remote typed-CBT.
Results:
Participants used the program for a median of 6 hours over 53 days. There was a large clinically meaningful reduction in anxiety symptoms for the intervention group (per-protocol (PP; n=169): change on GAD-7 = –7.4, d = 1.6; intention-to-treat (ITT; n=299): change on GAD-7 = –5.4, d = 1.1) that was statistically superior to the waiting control (PP: d = 1.3; ITT: d = 0.8), non-inferior to human-delivered care, and was sustained at one-month follow-up.
Conclusions:
By combining AI and human support, the digital intervention achieved clinical outcomes comparable to human-delivered care while significantly reducing the required clinician time by up to 8 times. These findings highlight the potential of technology to scale effective evidence-based mental healthcare, address unmet need, and ultimately impact quality of life and economic burden globally. Clinical Trial: ISRCTN ID: 52546704
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