Evaluating the Feasibility and Tolerability of a Digital Cognitive Training Intervention in Adults With ADHD: A Randomized, Placebo-controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- McMaster University
- Enrollment
- 52
- Primary Endpoint
- The feasibility of digital cognitive training on ADHD symptoms in adults diagnosed with ADHD of moderate-severe severity
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
The feasibility of digital cognitive training on ADHD symptoms in adults diagnosed with ADHD of moderate-severe severity
Time Frame: From enrollment to the end of treatment at 11 weeks
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.
Number of participants who prematurely withdraw from the study protocol
Time Frame: From enrollment to the end of treatment at 11 weeks
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.
The feasibility of digital cognitive training on ADHD symptoms in adults diagnosed with ADHD of moderate-severe severity
Time Frame: From enrollment to the end of treatment at 11 weeks
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.
Secondary Outcomes
- 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)
- The effects of digital cognitive training on verbal short-term and working memory in adults diagnosed with ADHD of moderate-severe severity(From enrollment to the end of treatment at 11 weeks)
- 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)
- The effects of digital cognitive training on verbal short-term and working memory in adults diagnosed with ADHD of moderate-severe severity(From enrollment to the end of treatment at 11 weeks)