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

Area of Science:

• Neuroscience
• Psychiatry
• Digital Health

Background:

• Attention-deficit/hyperactivity disorder (ADHD) frequently persists into adulthood, leading to significant functional impairments.
• Many adults with ADHD do not respond to or decline pharmacological treatments, highlighting the need for alternative interventions.
• Non-pharmacological approaches are crucial for managing adult ADHD effectively.

Purpose of the Study:

• To outline the protocol for a randomized controlled trial (RCT) assessing Sincrolab Adults, an AI-based cognitive stimulation program for adults with ADHD.
• To determine if 12 weeks of intervention enhances cognitive performance in adults with ADHD.
• To evaluate the program's impact on ADHD symptoms, quality of life, and the durability of its effects.

Main Methods:

• A single-blind, multicenter RCT comparing Sincrolab Adults to a treatment-as-usual control group.
• 104 adults diagnosed with ADHD will be randomized.
• Outcomes measured via MOXO Continuous Performance Test (CPT), Adult ADHD Self-Report Scale (ASRS), and Adult ADHD Quality of Life (AAQoL) scale, with a one-month follow-up.

Main Results:

• The primary outcome is improvement in CPT total scores.
• Secondary outcomes include reductions in ASRS-measured ADHD symptoms.
• Exploratory outcomes will assess quality of life, symptom subdomains, and treatment durability.

Conclusions:

• This study will provide data on the feasibility and preliminary efficacy of a digital cognitive stimulation platform for adult ADHD.
• Findings may support the development of scalable and accessible ADHD treatment options.
• Evidence on digital interventions can inform future therapeutic strategies for ADHD.