Adults with depressive or anxiety disorders and clinically relevant social traumatization.
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Sufficient German language proficiency to participate in psychotherapy and complete study assessments. Current DSM-5 diagnosis of a depressive disorder or anxiety disorder established with the Diagnostic Interview for Mental Disorders (DIPS). Clinically relevant social traumatization defined by at least one of the following: Emotional abuse (CTQ Emotional Abuse = 10), ALEX Social Threat Score = 7, Peer victimization (FBS = 5). Clinical judgement indicating that social traumatization substantially contributes to the current psychopathology. Written informed consent.
Exclusion criteria
Exclusion criteria: Current posttraumatic stress disorder (PTSD) or complex PTSD. Current psychotic disorder or acute psychotic symptoms. Bipolar I disorder. Acute substance dependence requiring primary addiction treatment. Acute suicidal crisis requiring inpatient treatment. Severe cognitive impairment or insufficient German language proficiency. Any other clinical condition that, in the judgement of the study supervisor, precludes safe participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the feasibility of delivering the NASSIM intervention under routine conditions in an academic outpatient psychotherapy clinic. Feasibility is evaluated at the end of treatment using the following parameters: recruitment rate (screening log), treatment completion and treatment exposure (therapist documentation), treatment fidelity (standardized therapist documentation), patient acceptability (standardized patient treatment evaluation questionnaire), therapist-rated feasibility (standardized therapist evaluation form), and intervention safety based on the frequency and type of adverse events (AEs) and serious adverse events (SAEs), which are monitored continuously throughout the treatment period. | — |
Secondary
| Measure | Time frame |
|---|---|
| Explorative Veränderungen der diagnostischen Schwere, sozialtraumabedingter Symptomatik, allgemeinen psychischen Belastung, Funktionsfähigkeit sowie der Patientenzufriedenheit. | — |
Countries
Germany
Contacts
Universität Bielefeld