Assessing Mobile Apps for Adult ADHD

ABSTRACT

ConditionAttention Deficit Hyperactivity Disorder

InterventionDevice UC-A;Device UC-N

Primary outcome:Conners Continuous Performance Task (CPT3) - HRT Std (Change from Baseline to Midpoint Mid-treatment, and Baseline to Endpoint Post-treatment)

Criteria
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-person
visits 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 Abbreviated
Scale 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 with
clinically significant levels of impairment, diagnosed by semi-structured clinical
interview and the Adult ADHD Clinical Diagnostic Scale (ACDS).

Exclusion Criteria

- History of diagnosis of childhood neurodevelopmental disorder including autism
spectrum disorder and dyslexia, other than ADHD or those specifically allowed in the
Allowed Disorders section.

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

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

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

- Substance or Alcohol Use Disorder rated as moderate or severe, with symptoms = 4, as
assessed by the MINI, or self-report of a Substance/Alcohol Use Disorder (allow
endorsement of substance or alcohol use that does not meet moderate-severe use
disorder criterion, if clean at visit).

- History of severe sleep disorder, narcolepsy, epilepsy/seizure disorder, brain tumor,
stroke, TBI, severe concussion resulting in loss of consciousness and hospitalization,
serious oxygen deprivation (such as following heart attack, carbon monoxide poisoning,
near drowning or near suffocation), encephalitis, meningitis, or other major
neurological disorder.

- History of chronic fatigue syndrome, Long-COVID.

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

- Current ongoing treatment, deemed by the participant and their PCP as indicated for
continued use during the study, with psychotropics suspected to alter attentional
functioning such as antipsychotic medications, sedative hypnotics, mood stabilizers,
benzodiazepines, atypical antidepressants, or anticonvulsants (listed in the Excluded
Medications List, or in the opinion of the investigator are likely to interfere with
study cognitive assessments).

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

- Current treatment with guanfacine (due to the unacceptable risks of rapid withdrawal)
and other medications for focus and attention problems such as Strattera, 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 prescription
medications that are on the Excluded Medications List.

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