F40.0 F40.00 F40.01 F40.1 F41.0 F41.1 F93.0 F93.2 F93.8
Conditions
Interventions
Group 1: Cortisol and oxytocin release under stress conditions in children and adolescents with anxiety disorder
Group 2: Cortisol and oxytocin release under stress conditions in healthy children and
Sponsors
Klinik und Poliklinik für Kinder- und Jugendpsychiatrie, Psychosomatik und Psychotherapie der Universität Regensburg am Bezirksklinikum Regensburg
Eligibility
Sex/Gender
All
Age
11 Years to 18 Years
Inclusion criteria
Inclusion criteria: General inclusion criteria of the index and control group • Sufficient understanding of the German language • Informed consent of study participants and their legal guardians • Age at baseline: 11-18 years • School education: middle school, junior high school, high school • Good connection to in- and outpatient diagnostic/medical consultation/ treatment at the Clinic for Child and Adolescent Psychiatry Regensburg. Inclusion criteria index group • Anxiety disorder according to the diagnostic criteria of the DSM-5 classification and ICD-10 Agoraphobia (ICD-10 F40.0) with/without a panic disorder (F40.00, F40.01), social phobias (F40.1), panic disorder (F41.0), generalized anxiety disorder (F41.1), separation anxiety disorder of childhood (F93.0), social (F93.2) and generalized (F93.80) anxiety disorder of childhood. • No further psychiatric comorbidities (except for mild depressive disorder, moderate depressive disorder (ICD-10 F32.0. F32.1)) Inclusion criteria control group • No history of psychiatric and neurological diseases • No current and history of in- and outpatient psychiatric and psychotherapeutic treatment and any psychiatric disorder
Exclusion criteria
Exclusion criteria: General exclusion criteria of the index group and control group • History of traumatic brain injury, history of endocrinological disorder, any other chronic neurological or other disorder, which influences the brain development and physiology • Current glucocorticoid-containing medication • Pregnancy • Early pubertal development (Pubertas präcox vera) due to an abnormal hormone status (Brämswig & Dübbers, 2009) • Intellectual impairment (IQ <85) • School education: special school • Acute psychotic disorder or acute psychiatric condition, which may affect the capacity to consent • Acute suicidality • Lack of consent Exclusion criteria control group • Anxiety score after answering the test questionnaires above the reference values defined by the respective test criteria and guidelines for evaluation • Diagnosed anxiety disorder according to DSM-5 and ICD-10 criteria • Any current or history of psychiatric and neurological disorder, which requires medical treatment • Current and history of in- and outpatient psychiatric and psychotherapeutic treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Basal saliva-oxytocin and cortisol levels of the test group (children and adolescents (11-18 years) with a diagnosed anxiety disorder) compared to a healthy control group (children and adolescents without clinical psychiatric diagnosis) 2. Change in oxytocin and cortisol levels under stress conditions (TSST) over time (time points: + 1, 5, 10, 20, 40 and 60 min after completion the TSST) 3. Change in cortisol levels under stress conditions in relation to oxytocin levels Methods: Taking saliva samples to determine the hormone concentrations at 8 different points of time. Induced stressful situation by the Trier Social Stress Test (Kirschbaum et al., 1993) The endpoint is recorded when 60 study participants are enrolled. | — |
Secondary
| Measure | Time frame |
|---|---|
| Physiological stress parameters: Recording the heart rate with pulse sensor Psychological stress parameters: Anxiety, insecurity and subjective stress with the Visual Analogue Scales (VAS, Hellhammer & Schubert, 2012) Dimensional psychiatric diagnosis regarding general psychopathology and anxiety disorder; Survey of the severity of mental illnesses: - SCARED-D: Screen for Child Anxiety Related Emotional Disorders (SCARED) - German Version (Birmaher et al., 1997) - SPAIK: Social phobia and fear inventory for children (Melfsen et al., 2001) - BAI: Beck Anxiety Inventory (Margraf et al., 2007) - BDI-II: Beck's Depression Inventory -II (Hautzinger et al., 2006) - ECR-RC: Short version of the Experiences in Close Relationships Scale-Revised Child version (Brenning et al., 2014) - STAI: State-Trait Anxiety Inventory for Adults (Spielberger 1970, 1973) - M.I.N.I-KID: Mini-International Neuropsychiatric Interviews for Children and Adolescents (M.I.N.I.-KID) (Sheehan et al., 1998) - PDS: Pubertal Development Scale (Petersen et al., 1988) - WISC-V: Wechsler Intelligence Scale for Children-V or WAIS-IV: Wechsler Adult Intelligence Scale-Fourth Edition; 4 subtests (Similarities, Vocabulary, Matrix Reasoning, Block Design) (Wechsler, 2017; by Aster et al., 2006) The endpoint is recorded when 60 study participants are enrolled. | — |
Countries
Germany
Contacts
Public ContactRomuald Brunner
Klinik und Poliklinik für Kinder- und Jugendpsychiatrie, Psychosomatik und Psychotherapie der Universität Regensburg am Bezirksklinikum Regensburg
Outcome results
None listed