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Completed

NCT Number: NCT06221930

Researching the Effectiveness of Attexis, a Digital Health Application for Adults With Attention Deficit Hyperactivity Disorder

In this randomized controlled clinical trial, 326 patients with ADHD will be investigated regarding the effectiveness of a digital therapeutic for improved ADHD symptomatology, the unguided online intervention attexis. Inclusion criteria are: male, female or non-binary, age 18-65, diagnosis of ADHD, elevated levels of ADHD symptoms (score of ≥17 either on the inattention subscale or on the impulsivity/hyperactivity subscale of the ASRS v1.1), stable treatment for at least 30 days at time of inclusion, sufficient German skills, and consent to participation. Exclusion criteria are: Diagnosis of any other severe psychiatric disorder and plans to change treatment in the upcoming three months. Patients will be randomized and allocated to either an intervention group, receiving access to attexis in addition to TAU, or a control group, receiving access to TAU only. Primary endpoint will be self-rated ADHD symptomatology, assessed via the ASRS v1.1, with three months post-allocation being the primary time point for assessment of effectiveness. Six months post allocation will be used as a timepoint for follow-up assessment of endpoints. Secondary endpoints will be depressive symptoms, self-esteem, work and social functioning, and health-related quality of life.

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Key information

Conditions

Adult Attention Deficit Hyperactivity Disorder Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Mental Disorders Neurodevelopmental Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

GAIA AG

Hamburg, 22085, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • women, men, non-binary
  • age 18-65 years
  • diagnosis of ADHD (assessed via DIVA)
  • ADHD severity score (cut-off): score of ≥17 either on the inattention subscale or on the impulsivity/hyperactivity subscale of the ASRS v1.1
  • stable treatment (psychotherapy, medication, no treatment, …) for at least 30 days at the time of inclusion
  • consent to participation
  • sufficient knowledge of the German language

Exclusion criteria

  • diagnosis of another severe psychiatric disorder (severe affective disorder, autism spectrum disorder, psychotic disorder, Borderline personality disorder, antisocial personality disorder, substance use disorder, suicidality)
  • plans to change treatment (psychotherapy, medication, …) in the upcoming three months after inclusion

Treatment and study plan

attexis

Behavioral

Participants will receive access to the digital health intervention attexis in addition to TAU.

Primary outcomes

  1. ADHD Symptom Severity

    Time frame: 3 months

    ASRS v1.1. Total score ranging from 0-72; higher scores mean more ADHD symptoms (worse outcome).

Secondary outcomes

  1. Depressive Symptomatology

    Time frame: 3 months, 6 months

    PHQ-9. Total score ranging from 0-27; higher scores mean more depressive symptomatology (worse outcome).

  2. Self Esteem

    Time frame: 3 months, 6 months

    Rosenberg Self Esteem Scale (RSES). Total score ranging from 0-30; higher scores mean higher self-esteem (better outcome).

  3. Functioning

    Time frame: 3 months, 6 months

    Work and Social Adjustment Scale (WSAS). Total score ranging from 0-40; higher scores mean higher impairment (worse outcome).

  4. Health-Related Quality of Life

    Time frame: 3 months, 6 months

    AQoL-8D. Total score ranging from 0-100; higher scores mean higher quality of life (better outcome).

  5. ADHD Symptom Severity

    Time frame: 6 months

    ASRS v1.1. Total score ranging from 0-72; higher scores mean more ADHD symptoms (worse outcome).

Sponsors and collaborators

Lead sponsor

Gaia AG

Industry

Collaborators

  • University Hospital, Saarland
  • Zentrum für Integrative Psychiatrie Kiel

Registry information

Official study title

Researching the Effectiveness of Attexis, a Digital Health Application for Adults With Attention Deficit Hyperactivity Disorder - a Randomized Controlled Trial

Acronym: READ-ADHD

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jan 24, 2024
Registry last updated
Jan 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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