F90.0 F98.80
Conditions
Interventions
Group 1: Participants in the intervention group (IG) will receive care as usual (CAU) as well as access to hiFoon® (CE-marked Class I medical device software) for the 12-week intervention period. hiFo
Sponsors
Medigital GmbH
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - Physician- or therapist-confirmed diagnosis of attention-deficit/hyperactivity disorder (ADHD) according to ICD-10 (F90.0 or F98.80); In case of an external ADHD diagnosis: written proof of diagnosis by a healthcare professional and confirmation by diagnostic interview (IDA-R) conducted by the investigator - Impaired emotion regulation, defined as a below-average total score on the SEK-27 (= 56) - No ADHD medication or stable ADHD medication for at least 4 weeks prior to inclusion - Ownership of a suitable smartphone (Android or iOS) - Sufficient German language skills to understand study materials - Written electronic informed consent
Exclusion criteria
Exclusion criteria: - Acute suicidality - Schizophrenia spectrum disorders, bipolar disorder, severe depressive disorder, dissocial or borderline personality disorder - Psychotic, manic, or severe depressive symptoms or severe substance dependence - Neurological disorder - Ongoing, recent (= 3 months), or planned psychotherapy - Planned change of ADHD medication within 3 months - Treatment with hypnotics - Use of another emotion-regulation app within the past 3 months - Previous use of hiFoon® or predecessor apps - Current participation in another clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in emotion regulation skills from T0 (baseline) to T2 (12 weeks), measured by the change in total score of the SEK-27 self-assessment questionnaire (Emotion Regulation Skills Questionnaire; ERSQ). The SEK-27 is assessed at T0 (baseline), T1 (8 weeks), T2 (12 weeks), and T3 (follow-up, 24 weeks). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change in total score of the Adult ADHD Quality of Life (AAQoL) questionnaire from T0 (baseline) to T2 (after 12 weeks) (key secondary outcome), assessed at T0, T1, T2, and T3. 2. Change in total score of the Conners’ Adult ADHD Rating Scale – Self-Report: Long Version (CAARS-SB-66) from T0 to T2, assessed at T0, T1, T2, and T3. 3. Change in score of the impulsivity and emotional lability (I/EL) subscale of the CAARS-SB-66 from T0 to T2, assessed at T0, T1, T2, and T3. 4. Total score of the Adverse Childhood Experiences Questionnaire (ACE-D), assessed at T0. 5. Change in emotion regulation skills (ER), assessed by Patient Global Impression of Change (PGIC), assessed at T2 and T3. 6. Assessment of the severity of ER problems and associated psychological distress (Likert scale; investigator rated), assessed at baseline visit and final visit. 7. User feedback on the app, including user satisfaction (CSQ-I questionnaire), assessed after app use duration (IG: T2, CG: T3). 8. Objective user behavior (e.g. number of logins, total duration of use), assessed continuously. 9. Safety (adverse events and device deficiencies), assessed at T1, T2, final visit, and T3. 10. ADHD therapies and medication, assessed at baseline visit, final visit, and T3. 11. Health economic aspects, assessed at final visit and T3. | — |
Countries
Germany
Contacts
Public ContactNatalie Sahlender
Klinik und Poliklinik für Psychiatrie und Psychotherapie, Universitätsklinikum Bonn
Outcome results
None listed