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Feasibility of Narrative Self-Simulation (NASSIM): A Transdiagnostic Single-Arm Feasibility Study

Feasibility of Narrative Self-Simulation (NASSIM): A Transdiagnostic Single-Arm Feasibility Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00040842
Enrollment
20
Registered
2026-07-22
Start date
2026-08-27
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Adults with depressive or anxiety disorders and clinically relevant social traumatization.

Interventions

Group 1: Narrative Self-Simulation (NASSIM) Manualized individual psychotherapy for adults with depressive or anxiety disorders and clinically relevant social traumatization. All participants receive
no control group is included. Before treatment, participants provide written informed consent and complete a baseline assessment including the Diagnostic Interview for Mental Disorders (DIPS), the So

Sponsors

Universität Bielefeld
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

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

MeasureTime 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

MeasureTime frame
Explorative Veränderungen der diagnostischen Schwere, sozialtraumabedingter Symptomatik, allgemeinen psychischen Belastung, Funktionsfähigkeit sowie der Patientenzufriedenheit.

Countries

Germany

Contacts

Public ContactFrank Neuner

Universität Bielefeld

frank.neuner@uni-bielefeld.de+49 521 1066871

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Aug 10, 2026