F90.0
Conditions
Interventions
Group 1: Interventional = 12-week app-based therapy to improve the quality of life in attention deficit hyperactivity disorder (ADHD) in adults
Group 2: Control group: Waiting control with delayed acc
Sponsors
MiNDNET E-Health AG
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: -ADHD diagnosis in adulthood according to ICD-10 (proof by physician's letter, certificate or other valid document) -Current impairments due to ADHD measured with the ASRS Screener (Adult ADHD Self-Report Scale) with a value of = 4 points -Access to a smartphone/tablet -Availability for the study period (12 weeks) -Ability to comply with the study protocol and complete the assessment measures (sufficient knowledge of the German language, including speaking, writing and reading) -Stability of prescribed ADHD medication for at least four weeks prior to the study, with no change in type or dosage of medication
Exclusion criteria
Exclusion criteria: -Diagnosis of severe unipolar depression, personality disorder (ICD-10: F60.3), bipolar affective disorder (ICD-10: F31) or schizophrenia, schizotypal and psychotic disorder (ICD-10: F2). -Alcohol and/or drug abuse (ICD-10: F1) -Acute suicidal tendencies (recorded by the 12th item of the QIDS-SR16 with = 2 points) -Current participation in ADHD-specific psychotherapy. -Running (re)adjustment to an approved ADHD-specific medication (incl. methylphenidate, lisdexamphetamine, atomoxetine) -Changes in the oral and maxillofacial region / larynx (ICD-10: Q31) and neurological disorders associated with severe speech and language impairments: Aphasia (ICD-10: F80.3 or R47.0), Apraxia (ICD-10: R48.2), Ataxia (ICD-10: G11)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome measures the quality of life in ADHD (Adult ADHD Quality of Life, AAQoL; Brod et al., 2006) after 12 weeks. The scale assesses the quality of life of adults with ADHD during therapy and has 29 items, which are rated on a five-point Likert scale from 1 ("Not at all/never") to 5 ("Extremely/very often"). | — |
Secondary
| Measure | Time frame |
|---|---|
| -Adult ADHD Self-Report Scale (ASRS; Kessler et al., 2005): The scale assesses the core symptoms of ADHD and consists of 18 items rated on a five-point scale from 0 ("Never") to 4 ("Very often") (T0, T1, T2). -Perceived Health Competence Scale (PHCS; Smith et al., 1995): The scale measures self-efficacy and competence in coping with one's own illness and health behavior. It includes 8 items which are rated on a five-point scale from 1 ("strongly disagree") to 5 ("strongly agree") (T0, T1, T2). -Medication Adherence Report Scale (MARS-D; Mahler et al., 2010): The questionnaire comprises 5 items answered on a 5-point Likert scale from never = 5 to always = 1 (T0, T1, T2). -Perceived Stress Scale 4 (PSS-4; Schäfer et al., 2023): The scale measures the extent of perceived stress during the last month and comprises 4 items rated on a five-point scale from "Never" (0) to "Very often" (4) (T0, T1, T2). -Patient Health Questionnaire (PHQ-9). The PHQ-9 (Gilbody et al., 2007; Kroenke et al., 2001) assesses depressive symptoms on a four-point scale from "not at all" (1) to "very good" (3) (T0, T1, T2). -Generalized Anxiety Disorder Scale 7 (GAD-7; Spitzer et al., 2006): The scale uses 7 items to measure anxiety symptoms during the last two weeks on a four-point scale from 0 ("Not at all") to 3 ("Almost every day") (T0, T1, T2). -Questionnaire for measuring patient satisfaction (ZUF-8; Schmidt et al., 1989): The ZUF-8 is a self-report questionnaire for measuring satisfaction with treatment (T2). | — |
Countries
Germany
Contacts
Public ContactSteffen Moritz
Universitätsklinikum Hamburg-Eppendorf
Outcome results
None listed