Evaluating a Digital Cognitive Training Intervention in Adults With ADHD

NCT07050225 | Not Yet Recruiting

• 1 other identifier: DCOG_ADHD
• Study Type: interventional
• Target: 52
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this clinical trial is to evaluate whether a digital cognitive training program can reduce symptoms of ADHD, improve executive functioning, and decrease problematic internet use in adults aged 18-65 with a diagnosis of moderate to severe ADHD. The main questions it aims to answer are: Can digital cognitive training improve executive function, and ADHD symptoms in adults with ADHD? Does digital cognitive training reduce problematic internet use in this population? Researchers will compare the digital cognitive training intervention group to a non-cognitive training digital platform to see if the training leads to greater improvements in cognitive and behavioral outcomes. Participants will: Complete an 11-week digital cognitive training program (3, 1-hour sessions/week) or placebo intervention (3, 1-hour sessions/week) Attend baseline, midpoint, and post-intervention assessments Participate in weekly check-ins to monitor engagement and tolerability

Conditions

ADHD

Keywords

ADHD; Attention Deficit Hyperactivity Disorder; Problematic Internet Use; PIU; Cognitive Training Intervention; Executive Functioning; Adult ADHD; ADHD Symptoms; Digital Health; Adjunct Therapy; Hyperactivity; Attention

Outcome Measures

Primary Outcomes (2)

• Number of participants who prematurely withdraw from the study protocol

  Tolerability of the digital cognitive training intervention will be assessed by calculating the number of participants who discontinue participation before completing the full 11-week study protocol. Premature withdrawal will be defined as any participant who discontinues the intervention and/or does not complete post-treatment assessments.

  From enrollment to the end of treatment at 11 weeks

• The feasibility of digital cognitive training on ADHD symptoms in adults diagnosed with ADHD of moderate-severe severity

  Feasibility will be evaluated based on the number of people who contact the study team, percent of people who contact who are eligible, and percent of eligible participants who enroll. Percent of participants lost to follow-up will be a key determinant of feasibility, as well as number of completers.

  From enrollment to the end of treatment at 11 weeks

Secondary Outcomes (6)

• The effect of digital cognitive training on ADHD symptoms in adults diagnosed with ADHD of moderate-severe severity

  From enrollment to the end of treatment at 11 weeks

• The effects of digital cognitive training on problematic internet use in adults diagnosed with ADHD of moderate-severe severity

  From enrollment to the end of treatment at 11 weeks

• The effects of digital cognitive training on visual processing and working memory in adults diagnosed with ADHD of moderate-severe severity

  From enrollment to the end of treatment at 11 weeks

• The effects of digital cognitive training on cognitive flexibility in adults diagnosed with ADHD of moderate-severe severity

  From enrollment to the end of treatment at 11 weeks

• The effects of digital cognitive training on working memory in adults diagnosed with ADHD of moderate-severe severity

  From enrollment to the end of treatment at 11 weeks

Other Outcomes (3)

• Changes on symptoms of anxiety

  From enrollment to the end of treatment at 11 weeks

• Changes on symptoms of depression

  From enrollment to the end of treatment at 11 weeks

• Changes in quality of life

  From enrollment to the end of treatment at 11 weeks

Study Arms (2)

Digital Cognitive Training

EXPERIMENTAL

Participants randomized to the intervention group will receive 1-hour cognitive training sessions three times weekly for 10 weeks. The digital cognitive training platform will consist of personalized gamified cognitive tasks that target individual cognitive deficits associated with ADHD including attention, impulsivity, working memory, and cognitive flexibility.

Other: Digital Cognitive Training

Digital Non-cognitive Training Intervention

PLACEBO COMPARATOR

Participants will use a control gamified computer platform matched for time but lacking cognitive training components. Participants will engage in this activity for 1 hour three times a week for a duration of 10 weeks.

Other: Digital Non-cognitive Training Intervention

Interventions

Digital Cognitive Training OTHER

This digital cognitive training program uses gamified tasks in order to enhance cognitive skills in an engaging manner using machine learning AI algorithms to target the intervention to individual cognitive skill deficits. It consists of personalized gamified cognitive tasks that target individual cognitive deficits associated with ADHD including attention, impulsivity, working memory, and cognitive flexibility.

Digital Cognitive Training

Digital Non-cognitive Training Intervention OTHER

This is a gamified computer platform lacking cognitive training components.

Digital Non-cognitive Training Intervention

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must provide informed consent and agree to comply with study protocols for the duration of the study.
• Participants must be fluent in speaking and reading English and able to complete rating scales and assessments.
• Participants must be adults aged 18-65 years.
• Participants must have a clinical diagnosis of ADHD based on DSM-5 Criteria, as confirmed by the Mini Neuropsychiatric interview.
• Participants being treated with pharmacotherapy must be stable and on a consistent dose for at least 6 weeks prior to study entry.
• Participants must have access to a computer capable of running the cognitive training platform.
• Participants must be comfortable operating a computer and be able to log on to the platform without assistance.

You may not qualify if:

• Exclude individuals who meet DSM-5 criteria for psychiatric conditions such as borderline personality disorder, schizophrenia, severe depression, or other psychotic disorders as well as neurological conditions such as epilepsy, dementia, and amnesia, that may interfere with cognitive training.
• Exclude participants with active substance use disorders.
• Exclude participants receiving behavioral therapy or undergoing similar cognitive training programs for ADHD and/or PIU.
• Exclude individuals with severe visual, auditory, or motor impairments that affect the ability to perform the digital cognitive training intervention.
• Exclude participants who are uncomfortable using applications or required technology.
• Exclude participants who have changed their treatment regimen in the last 6 weeks.
• Exclude participants who are not fluent in English.

Sponsors & Collaborators

• McMaster University: lead

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity; Spasm

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2025
• First Posted: July 3, 2025
• Study Start: August 1, 2025
• Primary Completion: January 1, 2026
• Study Completion: February 1, 2026
• Last Updated: July 22, 2025

Record last verified: 2025-06