F32 F33 F34 F38 F39 F40 F41 F42 F43 F45 F48
Conditions
Interventions
Group 1: Patients with an emotional disorder (diagnoses from the sections F32 - F39 or F4 according to ICD-10, exceptions see exclusion criteria) who receive cognitive-behavioral therapy in the outpat
Sponsors
Justus-Liebig-Universität Gießen
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Patients who are at the beginning of a psychotherapy (probatory phase) and have psychological problems in the domain of ??emotional disorders (anxiety (associated) or depressive disorder; diagnosis from the sections F32 - F39/F4, ICD-10), age = 18 years, indication for outpatient CBT treatment, willingness to participate in the study, minimum therapy duration of 12 sessions or regular end of therapy before 12 therapy sessions Healthy participants who do not currently meet the diagnostic criteria for a mental disorder.
Exclusion criteria
Exclusion criteria: Exclusion criteria for all participants: - Presence of certain diagnoses, namely: diagnoses from section F2 (according to ICD-10; e.g. schizophrenia), acute manic/hypomanic episode (diagnosis from the ranges F30 and F31, ICD-10). - acute suicidal tendencies - Presence of psychotic symptoms (e.g. in the context of a major depressive episode) - organic mental disorders and neurological diseases (e.g. dementia, epilepsy, stroke, multiple sclerosis) - Age < 18 years - Insufficient knowledge of German - Noncorrectable significant impairments in hearing and vision Additional exclusion criteria study part 2: - Cardiovascular or respiratory disease (e.g., condition following myocardial infarction, hypertension or hypertension requiring treatment, asthma, chronic obstructive pulmonary disease) - neurodermatitis on the palms of the hands - current severe hearing loss - difficulty breathing during simple physical activities (e.g. walking) - Pregnancy Additional exclusion criteria study part 3 (MRI): standard MRI exclusion criteria Additional exclusion criteria for healthy control participants: - Presence of mental disorder
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome is defined as the change score in the GSI (Global Severity Index of the Brief Symptom Inventory; Franke, 2000), measured during the routine diagnostics between therapy sessions 20-24. | — |
Secondary
| Measure | Time frame |
|---|---|
| External ratings (Clinical Global Impression (CGI); Social and Occupational Functional Assessessment Scale (SOFAS)), transdiagnostic symptom dimensions (Multidimensional Emotional Disorder Inventory (MEDI)), depression (BDI-II), subjective well-being (WHO-5) and impairments (Disability Index), as well as disorder-specific questionnaires (carried out during routine diagnostics) are used as secondary outcomes. In addition, transdiagnostically relevant constructs are assessed, which are emotion regulation (ASQ, IERQ, ERQ, HFERST), personality (BFI-10), worrying (PSWQ) and rumination (RSQ-K, PTQ), fear/anxiety (STAI-T, PROMIS-Level 2), anxiety sensitivity (ASI-3), social anxiety (SANB-5), intolerance of uncertainty (IUS), interpersonal problems (IIP-32) and interpersonal trust (KUSIV-3, Social Trust Scale), inhibition and avoidance (BIS/BAS), anticipatory and temporal pleasure (TEPS), flexibility (PBAT), gestures (BAG), and therapy expectancy (GEEE). Besides data collection at the beginning of therapy (probatory phase), primary and secondary outcomes will again be collected at T20 - 24 and at the individual end of therapy. In addition, for basic research questions, traumatic childhood experiences (CTQ) as well as traumatic experiences and trauma-associated symptoms in adulthood (LEC-5, PCL-5) will be assessed at the beginning of therapy. To investigate long-term treatment success, additional follow-up surveys were added. For this purpose, participants will be asked to complete the aforementioned questionnaires on transdiagnostic symptoms and mechanisms (as they did during the course of treatment) one, two, and three years after the end of therapy. In addition to the predictive questions, the project will also address other individual research questions of the involved working groups based only on pretherapy data (e.g., main effects of experiments and paradigms investigating transdiagnostic mechanisms and factors and their association with psychopathology and | — |
Countries
Germany
Contacts
Public ContactRudolf Stark
Justus-Liebig-Universität Gießen
Outcome results
None listed