A Randomized Controlled Trial of an Intelligent Cognitive Stimulation Program for Adults with ADHD: Study Protocol

Background: Attention-deficit/hyperactivity disorder (ADHD) often persists into adulthood, causing substantial functional impairments. While pharmacological treatments are considered first-line, many adults either decline or do not benefit from medication, underscoring the need for effective non-pharmacological interventions. Objective: This study describes the protocol for a randomized controlled trial (RCT) evaluating Sincrolab Adults, an AI-based cognitive stimulation program for adults with ADHD. The primary objective is to determine whether 12 weeks of intervention improves cognitive performance. Secondary and exploratory objectives assess its impact on ADHD symptoms, quality of life, and durability of effect. Methods: The study will employ a single-blind, multicenter, randomized controlled design comparing the digital cognitive intervention to a treatment-as-usual control group. A total of 104 adults diagnosed with ADHD will be randomized to either the Sincrolab Adults program or the control group. Outcomes will be measured using the MOXO Continuous Performance Test (CPT) for cognitive performance, the Adult ADHD Self-Report Scale (ASRS) for symptoms, and the Adult ADHD Quality of Life (AAQoL) scale. A one-month post-intervention follow-up will assess persistence of effects. Results: The primary outcome will be improvement in the CPT total score. Secondary outcomes include reductions in the ASRS symptoms. Exploratory outcomes will examine quality of life, ADHD symptom subdomains, and durability of improvements. Conclusions: This study will provide evidence on the feasibility and preliminary efficacy of a digital cognitive stimulation platform for adults with ADHD. Findings could support the development of scalable, accessible treatment alternatives for individuals with ADHD.