E10 E84 M08 F41 F32 F33 F34
Conditions
Interventions
Group 1: intervention group: guided internet and mobile-based intervention youthCOACHcd with 7 modules
meanwhile, standard medical care (treatment as usual = TAU) can (continue to) be used.
Group 2: control group: standard medical care (treatment as usual = TAU) can (continue to) be used (TAU) and addi
Sponsors
Universität Ulm, Fakultät Ingenieurwissenschaften, Informatik und Psychologie, Institut für Psychologie und Pädagogik, Abteilung für Klinische Psychologie und Psychotherapie
Eligibility
Sex/Gender
All
Age
12 Years to 21 Years
Inclusion criteria
Inclusion criteria: Symptoms of depression and/ or anxiety (PHQ-9 and/or GAD-7 >=7); Chronic disease (type 1 diabetes, cystic fibrosis or juvenile idiopathic arthritis); internet access; basic knowledge of the German language; participants informed consent (participants younger than 16 years require also the informed consent of parents/ person with custody)
Exclusion criteria
Exclusion criteria: Possible acute suicidality as indicated with PHQ-9 Item 9 > 1 at screening in clinical centres or medical practices
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome is the combined depressive and anxiety symptom severity at t2 (3 months post-randomisation), assessed with the Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS). | — |
Secondary
| Measure | Time frame |
|---|---|
| All primary and secondary outcome measurement instruments are online provided questionnaires (self-report or caregiver report). There are five assessment points: baseline (t0), 6 weeks (t1), 3 months (t2), 6 months (t3) and 12 months (t4) post-randomisation. Additionally, medical variables will be measured in clinical routine. Self-report: Sociodemographic variables (date of birth, gender, relationship status, type of school, grade of school or vocational training, and occupation) Depression and anxiety symptom severity (PHQ-ADS) (t1, t3, t4) Coping (CODI) (t0, t1, t2, t3, t4) Social Support (BSSS) (t0, t2, t4) Stress-related growth (SRGS) (t0, t1, t2, t3, t4) Self-Efficacy (GSE) (t0, t1, t2, t4) Traumatic Experiences (CATS, items 7-17) (t0, t1, t2, t3, t4) Behavioural Activation (BADS) (t0, t1, t2, t3) Automatic thoughts (ATQ-R) (t0, t1, t2, t3) Quality of life (EQ-5D-Y) (t0, t3, t4) Recorded in intervention group only: Intervention Satisfaction (CSQ-I) (t1, t2) Therapeutic alliance (WAI-SR) (t1, t2, t3) Caregiver Report: Anxiety symptom severity (SCARED) (t0, t1, t2, t3, t4) Depression symptom severity (MFQ) (t0, t1, t2, t3, t4) Social Support (BSSS) (t0, t2, t4) Traumatic experience (CATS-C-D, items 7-17) (t0, t1, t2, t3, t4) Side effects: Internet usage behaviour (IUES) (t0, t2, t3) Suicidal ideations (PHQ-9 Item 9 > 1, Beck Depressions-Inventar Revision (BDI-II) Item 9) (t0, t1, t2, t3, t4) Symptom Deterioration (PHQ-ADS) (t0, t1, t2, t3, t4) Recorded in intervention group only: Subjective side effects (INEP-On) (t2, t3, t4) Health economics: Quality of life (EQ-5D-Y) (t0, t3, t4) Child and Adolescent Service Receipt (CAMSHRI-DE) (t0, t3, t4) Medical variables: Type 1 Diabetes HbA1c, number of severe hypoglycaemias (with and without coma), DKA, CSII/ICT, insulin dose per day, SMBG, CGM/FGM, training and celiac disease diabetes education and presence of celiac disease Cystic fibrosis FEV 1, diabetes | — |
Countries
Germany
Contacts
Public ContactAgnes;Frederike Mutter;Lunkenheimer
Universität UlmFakultät Ingenieurwissenschaften, Informatik und PsychologieInstitut für Psychologie und PädagogikAbteilung für Klinische Psychologie und Psychotherapie;Universität Ulm, Fakultät Ingenieurwissenschaften, Informatik und Psychologie, Institut für Psychologie und Pädagogik, Abteilung für Klinische Psychologie und Psychotherapie
Outcome results
None listed