Clinical trial NCT06221930: Researching the Effectiveness of Attexis, a Digital Health Application for Adults With Attention Deficit Hyperactivity Disorder
Official title: Researching the Effectiveness of Attexis, a Digital Health Application for Adults With Attention Deficit Hyperactivity Disorder - a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adult Attention Deficit Hyperactivity Disorder
Lead sponsor: Gaia AG
Sponsor class: INDUSTRY
Collaborators: name: Zentrum für Integrative Psychiatrie Kiel
name: University Hospital, Saarland
First posted: 2024-01-24
Enrollment: 337
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: ADHD Symptom Severity
timeFrame: 3 months
Secondary outcomes:
measure: Depressive Symptomatology
timeFrame: 3 months, 6 months
measure: Self Esteem
timeFrame: 3 months, 6 months
measure: Functioning
timeFrame: 3 months, 6 months
measure: Health-Related Quality of Life
timeFrame: 3 months, 6 months
measure: ADHD Symptom Severity
timeFrame: 6 months
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: GAIA AG
Study officials:
affiliation: Zentrum für Integrative Psychiatrie Kiel
name: Eva Fassbinder, MD
role: PRINCIPAL_INVESTIGATOR
References: