EWM Training for ADHD

Overseen By Abigail Sullivan, MS

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Hartford Hospital

Disqualifiers: Psychosis, Bipolar, ASD, others

Compensation: Varies

Number of Visits: Unknown

Duration: 5 weeks

130 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a specific training called EWM Training can improve daily functioning in individuals with ADHD (Attention Deficit Hyperactivity Disorder). Researchers will compare this training to a placebo (a treatment with no active effect) to assess meaningful improvements. The trial seeks participants diagnosed with ADHD who speak English, are right-handed, and have a reading level above the 5th grade. Participants should not have braces, metal implants, or certain health conditions such as severe brain injuries or other mental health disorders. As an unphased trial, this study offers a unique opportunity to contribute to innovative research and potentially gain new insights into ADHD management.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that EWM Training for ADHD is generally easy for participants to handle. One study found that people could participate in the sessions without major problems. Although the study didn't focus on specific safety details, the emphasis on comfort and participant retention suggests that EWM Training doesn't cause serious side effects.

In this context, the lack of reported safety issues is encouraging. As this training undergoes further testing, ongoing studies will help confirm its safety. Those interested in joining these trials can feel somewhat reassured by the focus on comfort in earlier studies. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about EWM Training for ADHD because it offers a novel approach that focuses on enhancing executive working memory, which is often impaired in individuals with ADHD. Unlike standard treatments such as stimulant medications like Ritalin or Adderall, which primarily target neurotransmitters to control symptoms, EWM Training aims to improve cognitive functions through targeted exercises. This method could provide a non-pharmaceutical option with fewer side effects, making it a promising alternative or supplement to existing therapies. Additionally, the placebo training arm allows researchers to rigorously assess the specific impact of EWM Training, ensuring any observed benefits are genuine.

What evidence suggests that this trial's treatments could be effective for ADHD?

Research has shown that training in Executive Working Memory (EWM) might improve thinking skills related to ADHD. People with ADHD often find EWM tasks more challenging than simpler memory tasks. Early studies suggest that EWM training can significantly enhance thinking abilities and reduce ADHD symptoms. In this trial, participants in the ADHD EWM arm will receive EWM training sessions. One study found that participants improved their focus on tasks important for managing ADHD after EWM training. These findings suggest that EWM training could effectively address challenges associated with ADHD. ^{1 2 4 6 7}

Who Is on the Research Team?

Michael C Stevens, PhD

Principal Investigator

Institute of Living/Hartford Hospital

Are You a Good Fit for This Trial?

This trial is for individuals diagnosed with ADHD. Specific eligibility criteria are not provided, so it's important to contact the study organizers for detailed information on who can participate.

Inclusion Criteria

Diagnosis of ADHD

English speaking

Right-handed

Exclusion Criteria

Braces, metal, or implant devices

I have a brain condition or neurological disorder.

I have had a traumatic brain injury or was unconscious for over 30 minutes.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo executive working memory (EWM) training or placebo sessions 4 times each week for 5 weeks

5 weeks

Remote sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment, including changes in fMRI measurements and performance on cognitive tasks

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• EWM Training
• Placebo Training

Trial Overview The study is testing a training called EWM Training against a Placebo Training to see if it helps improve executive working memory and reduces symptoms of ADHD.

How Is the Trial Designed?

Group I: ADHD EWM Experimental Treatment 1 Intervention

Participants will receive EWM training sessions.

Group II: ADHD Placebo Placebo Group 1 Intervention

Participants will receive placebo training sessions.

Who Is Running the Clinical Trial?

Hartford Hospital

Lead Sponsor

Trials

140

Recruited

19,700+

Published Research Related to This Trial

In a study of 118 children with attention deficit disorder (ADD), three distinct response types to methylphenidate were identified: 'responders' who improved significantly on medication, 'nonresponders' who showed little change on both medication and placebo, and 'placebo responders' who improved on placebo similarly to responders on medication.

The presence of 'placebo responders' (18% of the group) highlights the importance of double-blind placebo-controlled evaluations in ADD treatment, as it helps prevent unnecessary medication for children who may only be experiencing nonspecific effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Responders, nonresponders, and placebo responders among children with attention deficit disorder. Importance of a blinded placebo evaluation. Ullmann, RK., Sleator, EK.[2017]

A meta-analysis of 128 randomized controlled trials involving over 19,000 participants revealed significant placebo effects on the efficacy of ADHD medications, indicating that non-specific factors can influence treatment outcomes.

While ADHD medications are more effective than placebo, the study highlights the importance of understanding and potentially incorporating placebo-related factors into clinical practice to enhance treatment responses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Placebo and nocebo responses in randomised, controlled trials of medications for ADHD: a systematic review and meta-analysis. Faraone, SV., Newcorn, JH., Cipriani, A., et al.[2022]

In a study involving 14 children with Attention Deficit Disorder with Hyperactivity (ADD + H), methylphenidate significantly improved verbal memory and learning compared to placebo, with effects increasing with higher doses.

The drug specifically enhanced the storage and retrieval of information rather than the immediate acquisition of new information, indicating a targeted mechanism of action in improving memory functions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Methylphenidate and memory: dissociated effects in hyperactive children. Evans, RW., Gualtieri, CT., Amara, I.[2019]

A study involving 53 children with ADHD demonstrated that computerized training of working memory (WM) significantly improved WM performance, as well as response inhibition and reasoning skills, both immediately after training and at a 3-month follow-up.

Parents reported a significant reduction in symptoms of inattention and hyperactivity/impulsivity in their children after the WM training, indicating that this intervention may effectively address key challenges associated with ADHD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computerized training of working memory in children with ADHD--a randomized, controlled trial. Klingberg, T., Fernell, E., Olesen, PJ., et al.[2022]

Cogmed Working Memory Training (CWMT) significantly improved short-term memory performance in children with ADHD on tasks similar to the training activities, compared to a placebo group.

However, CWMT did not lead to improvements in broader ADHD symptoms, such as attentional problems, impulsivity, or academic performance in reading, spelling, comprehension, or mathematics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Commentary: Working memory training and ADHD - where does its potential lie? Reflections on Chacko et al. (2014). Gathercole, SE.[2022]

In a study of 24 adults with ADHD, 66.67% completed a 25-session computerized working memory training program, indicating good feasibility and acceptability in a psychiatric outpatient setting.

Preliminary results showed that participants experienced fewer cognitive difficulties and improved neuropsychological performance after training, suggesting that this intervention may be effective and warrants further research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computerized working memory training for adults with ADHD in a psychiatric outpatient context-a feasibility trial. Sjöwall, D., Berglund, M., Hirvikoski, T.[2023]

The study involved 30 children with ADHD who underwent working memory training, showing significant improvements in working memory and inhibitory control after the intervention.

The Active Memory Intervention (AMIN) not only enhanced cognitive functions but also reduced ADHD symptoms in both home and school settings, indicating its effectiveness as a transferable intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of comprehensive working memory training on executive functions and behavioral symptoms in children with attention deficit-hyperactivity disorder (ADHD). Nejati, V., Derakhshan, Z., Mohtasham, A.[2023]

In a study involving normal adult males, magnesium pemoline (25 or 37.5 mg) was found to be less effective than a placebo in various learning and memory tests, indicating potential ineffectiveness as a cognitive enhancer.

The study included tests for verbal learning, motor learning, and memory retention, but the only significant finding was that those taking pemoline performed worse than those taking the placebo.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Magnesium pemolone: lack of facilitation in human learning, memory, and performance tests. Smith, RG.[2019]

A systematic review of 8 studies involving 393 children with ADHD found that methylphenidate (MPH) significantly reduces daytime activity levels compared to placebo, indicating its efficacy in managing hyperactivity.

However, the use of MPH was associated with a significant decrease in total sleep time, suggesting a potential adverse effect on sleep patterns in children undergoing treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of actigraphy in the monitoring of methylphenidate versus placebo in ADHD: a meta-analysis. De Crescenzo, F., Armando, M., Mazzone, L., et al.[2014]

In a study involving 540 children with ADHD, a significant placebo response was observed, with parents reporting a greater improvement (10.57 points) compared to teachers (3.93 points), highlighting the influence of observer perspective on treatment outcomes.

Various psychosocial factors, such as income and education for parents, and ethnicity for teachers, were found to affect the magnitude of the placebo response, suggesting that these factors should be considered in clinical trial designs and interpretations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Placebo response and its determinants in children with ADHD across multiple observers and settings: A randomized clinical trial. Fageera, W., Traicu, A., Sengupta, SM., et al.[2021]

A study involving 67 children with ADHD showed that a 25-day computerized working memory training program led to significant long-term improvements in working memory tasks, particularly in the visual domain.

The training resulted in lasting gains in performance across various working memory measures, suggesting that targeted interventions can be effective for children with ADHD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

RCT of working memory training in ADHD: long-term near-transfer effects. Hovik, KT., Saunes, BK., Aarlien, AK., et al.[2021]

Cognitive training, specifically Cogmed Working Memory Training and 'Paying Attention in Class,' can be beneficial for children with ADHD, but the effectiveness varies based on individual factors like ADHD subtype and comorbid conditions.

Initial cognitive abilities, such as verbal and visual working memory skills, primarily influence near transfer outcomes, while parent and teacher ratings of executive functioning are more affected by the subtype of ADHD, suggesting that personalized approaches may enhance treatment efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictors and Moderators of Treatment Outcome in Cognitive Training for Children With ADHD. van der Donk, MLA., Hiemstra-Beernink, AC., Tjeenk-Kalff, AC., et al.[2021]

Citations

1. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/84/NCT06446284/Prot_SAP_000.pdf

Target ADHD Executive Working Memory Training ... This proposal is based on converging evidence that suggests prior ADHD working memory training studies might have produced lackluster clinical outcomes ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11465636/

A Randomized Clinical Trial to Evaluate Feasibility ... These include meta-analysis findings showing that performance on EWM tasks is significantly more impaired than on tasks assessing simple WM ...

3. biologicalpsychiatryjournal.com biologicalpsychiatryjournal.com/article/S0006-3223(24)00409-8/fulltext

73. Preliminary Efficacy Findings for a Placebo Controlled ... This study characterized the effects of EWM training on non-trained cognitive ability and clinical efficacy outcomes.

4. consultant360.com consultant360.com/exclusive/feasibility-and-efficacy-executive-working-memory-training-adolescents-attention

Feasibility and Efficacy of Executive Working Memory ... These improvements were statistically significant and suggest that the EWM training was effective in engaging relevant cognitive processes for ADHD management.

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39173523/

A randomized clinical trial to evaluate feasibility, tolerability ... This randomized, placebo-controlled study was designed to assess feasibility, tolerability, and behavioral target engagement of a novel EWM training for ADHD.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04795674

Target ADHD Executive Working Memory Study This study will assess whether or not a novel executive working memory training intervention for Attention-Deficit/Hyperactivity Disorder can engage ...

7. withpower.com withpower.com/trial/phase-attention-deficit-hyperactivity-disorder-adhd-11-2023-7f915

EWM Training for ADHD The research articles reviewed do not provide specific safety data for EWM Training or similar interventions like placebo treatments in ADHD. They focus on the ...