DSM-5 diagnoses from the areas of anxiety disorders, depressive disorders, obsessive-compulsive disorders and related disorders, trauma and stress-related disorders, somatic symptom disorders and related disorders
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Patients: A DSM-5 diagnosis from the areas of anxiety disorders, depressive disorders, obsessive-compulsive disorder and related disorders, trauma- and stress-related disorders, somatic symptom disorder and related disorders; indication for group therapy (Unified Protocol) All participants: Sufficient German language skills and the ability to give informed consent
Exclusion criteria
Exclusion criteria: Patients: acute suicidality or acute self-harming behavior, bipolar disorder, psychotic symptoms/disorders, substance use disorders (current moderate or severe, past severe; excluding tobacco), borderline personality disorder, organic mental disorders and neurological diseases (e.g., dementia, epilepsy, stroke, multiple sclerosis), serious physical illnesses, significant, uncorrectable hearing and vision impairments; Psychotropic drugs/medications affecting the CNS if the dose has not been stable for 4 weeks Healthy control subjects: current or past mental disorder (assessed with Mini-DIPS), organic mental disorders and neurological diseases (e.g., dementia, epilepsy, stroke, multiple sclerosis), use of psychotropic drugs or other medications/substances affecting the central nervous system, serious physical illness, significant, uncorrectable hearing and vision impairments
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in the GSI (Global Severity Index des Brief Symptom Inventory; Franke, 2000) from before the start of therapy to after the end of therapy. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints include external ratings (Clinical Global Impression (CGI); Social and Occupational Functional Assessment Scale (SOFAS)), change score on the Multidimensional Emotional Disorder Inventory (MEDI; Rossellini et al., 2018) , depression (BDI-II), subjective well-being (WHO-5), and impairment (Disability Index), as well as disorder-specific questionnaire measures (routine diagnostics). Furthermore, other transdiagnostically relevant constructs will be assessed, namely emotion regulation (ASQ, IERQ, ERQ, HFERST), personality (BFI-10), worrying tendency (PSWQ) and rumination (RSQ-K, PTQ), 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 temporary pleasure (TEPS), flexibility (PBAT), and therapy expectations (GEEE). In addition to the assessment at the start of therapy (probationary phase), the aforementioned measures of the primary and secondary endpoints will be assessed at the end of group therapy and 6 months after the end of therapy (follow-up). Furthermore, for basic research purposes, trauma-associated symptoms (LEC-5, PCL-5), are recorded at the start of therapy. In addition to questions regarding prediction and treatment effect, further individual questions based solely on pre-therapy data (e.g., main effects of the emotion regulation experiment and their relationship to psychopathology and transdiagnostic symptoms) are also investigated. Furthermore, group differences between patients and healthy controls with respect to the recorded characteristics are examined. | — |
Countries
Germany
Contacts
Justus-Liebig-Universität Gießen