AzTrials
AzTrials

ADHDNCT07050225

Evaluating a Digital Cognitive Training Intervention in Adults With ADHD

A study testing Digital Cognitive Training and Digital Non-cognitive Training Intervention in people with ADHD, run by McMaster University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
ADHD
What is being tested?
Digital Cognitive Training and Digital Non-cognitive Training Intervention
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
52 participants
Where
No sites listed yet
Study dates
Aug 2025to Feb 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

About this study

Official title: Evaluating the Feasibility and Tolerability of a Digital Cognitive Training Intervention in Adults With ADHD: A Randomized, Placebo-controlled Trial

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?

Read more

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
Being tested
Digital Cognitive Training, Digital Non-cognitive Training Intervention
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
Medical subject headings
Attention Deficit Disorder with Hyperactivity, Spasm

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Digital Cognitive TrainingOther

    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 Non-cognitive Training InterventionOther

    This is a gamified computer platform lacking cognitive training components.

Study groups in NCT07050225
Study groupRoleWhat they receive
Digital Cognitive TrainingExperimentalParticipants 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.
Receives: Other: Digital Cognitive Training
Digital Non-cognitive Training InterventionPlacebo comparatorParticipants 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.
Receives: Other: Digital Non-cognitive Training Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: From enrollment to the end of treatment at 11 weeks

  2. 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.

    Measured: From enrollment to the end of treatment at 11 weeks

Secondary outcomes (6)

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

    ADHD symptom severity will be measured via the Barkley Adult ADHD Rating Scale (BAARS-IV). The minimum score on the Barkley ADHD Rating Scale is 0, and the maximum score is 54. The scale consists of 18 items, each rated on a scale of 0 to 3, where 0 indicates the absence of the symptom and 3 indicates a high level of severity.

    Measured: From enrollment to the end of treatment at 11 weeks

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

    Changes in the severity of problematic internet use will be evaluated via changes in Compulsive Internet Use Scale (CIUS) scores.

    Measured: From enrollment to the end of treatment at 11 weeks

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

    Performance on Trails A and B task will be evaluated.

    Measured: From enrollment to the end of treatment at 11 weeks

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

    Performance on Berg's Card Sorting Task will be evaluated.

    Measured: From enrollment to the end of treatment at 11 weeks

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

    Performance on N-back Task will be evaluated.

    Measured: From enrollment to the end of treatment at 11 weeks

  6. The effects of digital cognitive training on verbal short-term and working memory in adults diagnosed with ADHD of moderate-severe severity

    Performance on the Digit Span Test will be evaluated.

    Measured: From enrollment to the end of treatment at 11 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jul 2025
  2. Study startAug 2025 (estimated)
  3. Primary completionJan 2026 (estimated)
  4. Study completionFeb 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
52 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07050225
Sponsor's protocol ID
DCOG_ADHD
Status last verified
Jun 2025
First submitted
6 Jun 2025
Last updated
22 Jul 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Digital Cognitive Training and Digital Non-cognitive Training Intervention in people with ADHD, run by McMaster University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 22 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants who prematurely withdraw from the study protocol (time frame: From enrollment to the end of treatment at 11 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07050225.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in