F90.0
Conditions
Interventions
Group 1: Access to the digital health application ORIKO®
Group 2: Receives no additional treatment during the intervention period („care as usual“ only)
receives access to the intervention after 12 weeks (after the last follow-up)
Sponsors
MiNDNET E-Health AG
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: • At least 18 years old • ADHD diagnosis according to ICD-10 or DSM-5 with details of the date of diagnosis and the diagnosing doctor/therapist/institution (e.g., through a doctor's letter). • Access to a smartphone/tablet. • Availability for the study period (12 weeks). • Sufficient knowledge of the German language, including speaking, writing, and reading. • Current impairments due to ADHD measured with the ASRS screener with a score of = 14 points. • Stability of prescribed ADHD medication for at least four weeks prior to the study, without any change in the type or dosage of the medication.
Exclusion criteria
Exclusion criteria: • Current diagnosis of a severe mental disorder, including severe unipolar depression (ICD-10: F32.2), bipolar affective disorder (ICD-10: F31), emotionally unstable personality disorder (ICD-10: F60.3), or schizophrenia, schizotypal and delusional disorders (ICD-10: F2) • Ongoing alcohol and/or drug dependence (ICD-10: F1x.2) • Current suicidality • Ongoing participation in ADHD-specific psychotherapy • Ongoing (new) initiation or adjustment of an approved ADHD-specific medication (methylphenidate, amphetamine, atomoxetine) • Presence of a serious illness that, in the opinion of the principal investigator, excludes participation of the patient in the study until its completion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement in self-reported quality of life from T0 to T2, measured with the AAQoL (Brod et al., 2006; doi.org/10.1007/s11136-005-8325-z) | — |
Secondary
| Measure | Time frame |
|---|---|
| • Improvement in self-reported health status (ASRS; Kessler et al., 2005; doi.org/10.1017/s0033291704002892) • Improvement in functional impairment at T2 compared to T0, measured using an adapted item from the CGI-S (Busner & Targum, 2007; PMC2880930) • Reduction in depressive symptoms from T2 compared to T0, measured with the PHQ-9 (Gräfe et al., 2004; doi.org/10.1026/0012-1924.50.4.171; Kroenke et al., 2001; doi.org/10.1046/j.1525-1497.2001.016009606.x) • Reduction in anxiety symptoms from T2 compared to T0, measured with the GAD-7 (Mills et al., 2014, doi.org/10.1037/a0036523; Spitzer et al., 2014; 10.1001/archinte.166.10.1092) • Reduction in the severity of substance use disorders from T2 compared to T0, measured with the AUDIT-C (Bush et al., 1998; doi.org/10.1001/archinte.158.16.1789) and the DUDIT (Berman et al., 2005; doi.org/10.1159/000081413) • Improvement in self-efficacy and competence in managing one’s own condition, as well as in health behaviour, from T2 compared to T0, measured with the HLS-EU (Sørensen et al., 2013; doi.org/10.1186/1471-2458-13-948) • Reduction in functional impairments from T2 compared to T0, measured with the BFIS (Sasser et al., 2017, doi.org/10.1007/s40263-016-0400-1) • Increase in adherence to medication from T2 compared to T0, measured with the MARS-D (Mahler et al., 2010, doi.org/10.1111/j.1365-2753.2009.01169.x) | — |
Countries
Germany
Contacts
Public ContactSteffen Moritz
Universitätsklinikum Hamburg-Eppendorf Klinik und Poliklinik für Psychiatrie und Psychotherapie
Outcome results
None listed