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Transdiagnostic mechanisms in maltreatment-associated psychopathology in adolescents: Investigating inflammatory and regulatory flexibility

Transdiagnostic mechanisms in maltreatment-associated psychopathology in adolescents: Investigating inflammatory and regulatory flexibility

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00036449
Enrollment
150
Registered
2025-05-14
Start date
2025-06-04
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

Emotion regulation and inflammation in the link between child maltreatment and mental disorders in inpatients and outpatients undergoing psychiatric or psychotherapeutic treatment

Interventions

Group 1: Adolescents with a history of child maltreatment and adolescents without a history of child maltreatment who are undergoing treatment for psychiatric/psychological symptoms. In this study ar
KERF-40-I) - International Trauma Questionnaire (ITQ) including the Complex PTSD Scale (German Adolescents' Version) - Youth Self Report (YSR11–18R) - Visual analogue scales for life satisfaction - Co

Sponsors

Klinik für Kinder- und Jungendlichenpsychiatrie, Psychosomatik und Psychotherapie; Universitätsklinikum Ulm
Lead Sponsor

Eligibility

Sex/Gender
All
Age
13 Years to 17 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria Patients with a history of child maltreatment: (1) In inpatient or outpatient treatment for various psychiatric or psychological symptoms (2) Experience of child maltreatment (3) Age between 13 and 17 years (4) Sufficient knowledge of the German language (5) Availability of the signed declaration of consent (patient, if necessary legal guardian) (6) Own smartphone Inclusion criteria Patients without a history of child maltreatment: (1) In inpatient or outpatient treatment for various psychiatric or psychological symptoms (2) No history of child maltreatment (but potentially other traumatic experiences) (3) Age between 13 and 17 years (4) Sufficient knowledge of the German language (5) No permanent medication with antidepressants or antipsychotics (6) No intake of systemic corticosteroids within the last 2 months (7) No acute physical illnesses (8) No fever in the last seven days (9) No other severe symptoms indicating activation or suppression of the immune system (example: purulent sputum, congenital or acquired immunodeficiency) (10) Availability of the signed declaration of consent (patient, if necessary legal guardian) (11) Own smartphone

Exclusion criteria

Exclusion criteria: Exclusion criteria Patients with a history of child maltreatment: (1) Fixed medication with antidepressants or antipsychotics (2) Intake of systemic corticosteroids within the last 2 months (3) Acute physical illnesses (e.g. injuries) (4) Fever in the last seven days (5) Other severe symptoms indicating activation or suppression of the immune system (e.g. purulent sputum, congenital or acquired immunodeficiency)

Design outcomes

Primary

MeasureTime frame
The primary endpoint comprises four dimensions: 1. Inflammatory Activation: Inflammatory activity will be assessed using immunological markers derived from a one-time blood sample (20 ml of whole blood). Blood samples will be collected at the first time point (baseline). Inflammatory activity will be measured via blood cells, with a specific focus on the impact of psychological trauma on immune system cells. Inflammatory reactivity will be analyzed ex vivo through inflammatory stimulation using lipopolysaccharides (LPS). To assess leukocyte response to potential physical trauma, whole blood will be stimulated with a mixture of damage-associated molecular patterns (DAMPs), including mitochondrial DNA, free histones, HMGB1, and complement activation products (C3a and C5a) at trauma-relevant concentrations. Parameters of the innate immune system (e.g., CRP, IL-1beta/IL1-RA, IL-6, IL-8, MIP-1Alpha, TNF-alpha) and the adaptive immune system (e.g., IL-2, IL-4, IL-5, IL-7, IL-9, IL-10, IL-13, IL-17, IFN-gamma) will be measured using multiplex and ELISA assays, as well as conventional cell counting methods. Blood samples will be kept on ice and transported to the laboratory within a maximum of 1.5 hours. Measurements will include baseline values and responses to LPS and DAMP stimulation. 2. Flexible Self-Regulation: Aspects of flexible self-regulation — context sensitivity, strategy repertoire, and feedback responsiveness — will be assessed over a 10-day period using ecological momentary assessment (EMA). Data collection will begin immediately after the baseline assessment. Participating adolescents will receive smartphone notifications twice daily via the samply app (https://samply.uni-konstanz.de/). At midday, the survey captures the day’s most emotional situation with specific questions: “What happened? When? Where? Who was involved? What did you and others do?” The three components of emotion regulation will then be assessed: 1) Context Sensitivity: Participants evalu

Secondary

MeasureTime frame
- Trauma- and stress-related symptoms - Life satisfaction - Social desirability

Countries

Germany

Contacts

Public ContactVera Clemens

Klinik für Kinder- und Jungendlichenpsychiatrie, Psychosomatik und Psychotherapie

vera.clemens@uniklinik-ulm.de+49 731 500-61611

Outcome results

None listed

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