Adult Attention Deficit Hyperactivity Disorder
Conditions
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.
Interventions
BEHAVIORALattexis
Participants will receive access to the digital health intervention attexis in addition to TAU.
Sponsors
Zentrum für Integrative Psychiatrie Kiel
University Hospital, Saarland
Gaia AG
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ADHD Symptom Severity | 3 months | ASRS v1.1. Total score ranging from 0-72; higher scores mean more ADHD symptoms (worse outcome). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Depressive Symptomatology | 3 months, 6 months | PHQ-9. Total score ranging from 0-27; higher scores mean more depressive symptomatology (worse outcome). |
| Self Esteem | 3 months, 6 months | Rosenberg Self Esteem Scale (RSES). Total score ranging from 0-30; higher scores mean higher self-esteem (better outcome). |
| Functioning | 3 months, 6 months | Work and Social Adjustment Scale (WSAS). Total score ranging from 0-40; higher scores mean higher impairment (worse outcome). |
| Health-Related Quality of Life | 3 months, 6 months | AQoL-8D. Total score ranging from 0-100; higher scores mean higher quality of life (better outcome). |
| ADHD Symptom Severity | 6 months | ASRS v1.1. Total score ranging from 0-72; higher scores mean more ADHD symptoms (worse outcome). |
Countries
Germany
Outcome results
None listed