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Neural correlates of Emotion Regulation and the Unified Protocol for the Treatment of Emotional Disorders

Neural correlates of Emotion Regulation and the Unified Protocol for the Treatment of Emotional Disorders - EmoReg-UP

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00038770
Enrollment
160
Registered
2026-01-06
Start date
2026-01-19
Completion date
Unknown
Last updated
2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Group 1: Patients with emotional disorders are enrolled and treated using the Unified Protocol in a group psychotherapy setting (minimum 12 sessions of 100 minutes each). Additional preparatory and ac

Sponsors

Justus-Liebig-Universität Gießen
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

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

MeasureTime 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

MeasureTime 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

Public ContactAndrea Hermann

Justus-Liebig-Universität Gießen

andrea.hermann@psychol.uni-giessen.de+496419926334

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Apr 4, 2026