Assessing Mobile Apps for Adult ADHD

Last updated: March 6, 2025
Sponsor: Think Now Incorporated
Overall Status: Completed

Phase

N/A

Condition

Attention Deficit/hyperactivity Disorder (Adhd - Adults)

Autism Spectrum Disorder (Asd)

Williams Syndrome

Treatment

UC-A

UC-N

Clinical Study ID

NCT06256003
SAC-II
  • Ages 18-50
  • All Genders

Study Summary

The purpose of this clinical trial is to evaluate the effects of mobile app digital therapies on cognitive function and symptoms in adults diagnosed with ADHD.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • The participant is aged 18-50 years at time of consent

  • Fluent in English.

  • Available for 2 contiguous months to participate in study, including 3 in-personvisits to the university.

  • Able to sit in a regular chair for 30 minutes in a small room for testing.

  • Able to use a keyboard with both hands.

  • Normal or corrected to normal vision and hearing.

  • Have a smart Phone.

  • Estimated Intelligence Quotient (IQ) > 80 as assessed by the Wechsler AbbreviatedScale Intelligence (WASI-II) Matrix Reasoning and Vocabulary subtests.

  • Meet established Diagnostic and Statistical Manual of Mental Health-Fifth Edition (DSM-5-TR) presentation for ADHD predominantly inattentive or combined subtype withclinically significant levels of impairment, diagnosed by semi-structured clinicalinterview and the Adult ADHD Clinical Diagnostic Scale (ACDS).

Exclusion

Exclusion Criteria:

  • History of diagnosis of childhood neurodevelopmental disorder including autismspectrum disorder and dyslexia, other than ADHD or those specifically allowed in theAllowed Disorders section.

  • Lifetime history of DSM5 bipolar disorder, psychotic disorder, panic disorder,agoraphobia, obsessive compulsive disorder as assessed with the MINI InternationalNeuropsychiatric Interview (MINI).

  • Current DSM5 diagnosis of posttraumatic stress disorder, or Major DepressiveDisorder or Major Depressive Episode via self-report or as assessed with the MINI.

  • Current Persistent Depressive Disorder (Dysthymia) or Anxiety Disorder if not onallowed medication that has been at a stable dose for at least 8 weeks (if onallowed medication with stable dose for 8 weeks, then allow).

  • Substance or Alcohol Use Disorder rated as moderate or severe, with symptoms ≥ 4, asassessed by the MINI, or self-report of a Substance/Alcohol Use Disorder (allowendorsement of substance or alcohol use that does not meet moderate-severe usedisorder criterion, if clean at visit).

  • History of severe sleep disorder, narcolepsy, epilepsy/seizure disorder, braintumor, stroke, TBI, severe concussion resulting in loss of consciousness andhospitalization, serious oxygen deprivation (such as following heart attack, carbonmonoxide poisoning, near drowning or near suffocation), encephalitis, meningitis, orother major neurological disorder.

  • History of chronic fatigue syndrome, Long-COVID.

  • Other medical or psychiatric conditions that are sufficient to likely compromisecurrent attentional function and assessment in the opinion of the investigator.

  • Current ongoing treatment, deemed by the participant and their PCP as indicated forcontinued use during the study, with psychotropics suspected to alter attentionalfunctioning such as antipsychotic medications, sedative hypnotics, mood stabilizers,benzodiazepines, atypical antidepressants, or anticonvulsants (listed in theExcluded Medications List, or in the opinion of the investigator are likely tointerfere with study cognitive assessments).

  • Participant is currently considered a suicide risk in the opinion of theInvestigator, has previously made a suicide attempt, or has a prior history of, oris currently demonstrating active suicidal ideation or self-injurious behavior asmeasured by Columbia Suicide Severity Rating Scale at screening.

  • Current treatment with guanfacine (due to the unacceptable risks of rapidwithdrawal) and other medications for focus and attention problems such asStrattera, Modafinil, Armodafinil, and Clonidine that require long wash out periods (see Excluded ADHD Medications List).

  • Participant plans to initiate during the primary study new concomitant prescriptionmedications that are on the Excluded Medications List.

  • Participant plans to initiate during the primary study behavioral therapy ortraining to improve cognition by means of game or app-based cognitive trainings orneurofeedback.

Study Design

Total Participants: 140
Treatment Group(s): 2
Primary Treatment: UC-A
Phase:
Study Start date:
January 03, 2024
Estimated Completion Date:
November 23, 2024

Study Description

The study is a randomized, parallel group, controlled trial of two mobile app digital therapies. The study will consist of initial screening tests and diagnostics to determine eligibility, followed by outcome measure testing and treatment. On Day 0, the Baseline visit will occur wherein the pre-treatment (baseline) assessments will be conducted on-site. The Treatment period (Day 1 to Day 49) will involve using the digital therapy at home. Midpoint (Day 25) assessments will be conducted on-site to assess key outcomes. Final Post-Treatment (Day 50) assessments will be conducted on-site to assess key outcomes.

Connect with a study center

  • University of California Berkeley

    Berkeley, California 94720
    United States

    Site Not Available

  • UCLA Semel Institute

    Los Angeles, California 90095
    United States

    Site Not Available

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