Development and neurobiological investigation of a social-cognitive intervention for patients with schizophrenia

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

DRKS

Registry ID

DRKS00025907

Enrollment

Registered

2021-08-12

Start date

2021-10-01

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

F20-F29

Interventions

Group 1: Patients with schizophrenia - computer-assisted social-cognitive intervention, 4 sessions Group 2: Healthy controls - computer-assisted social-cognitive intervention, 4 sessions

Eligibility

Sex/Gender

All

Age

18 Years to 55 Years

Inclusion criteria

Inclusion criteria: 1) Signed informed consent 2) For all patients, a diagnosis in the schizophrenia spectrum according to ICD-10 criteria (F20.-29.)

Exclusion criteria

Exclusion criteria: 1) Neurological pre-existing conditions 2) MRI incompatibility (detected by MRI screening) 3) Lack of ability to consent to study participation

Design outcomes

Primary

Measure	Time frame
Reduction of negative symptoms in patients with schizophrenia as measured by the Scale for the Assessment of Negative Symptoms (SANS, post vs. pre intervention).	—

Secondary

Measure	Time frame
1) It is expected that during the intervention, the patient group will approach the control group in the pre-post comparison in the following endpoints: i) Behavioral change in social-cognitive paradigms: a) Prisoner's Dilemma Game b) Probabilistic Decision Task c) Social Memory Task ii) fMRI - iomarkers identified from the above mentioned experimental paradigms iii) Clinical and cognitive scales 2) Both groups (patients and controls) are expected to benefit from the intervention in the above mentioned endpoints	—

Measure

Time frame

1) It is expected that during the intervention, the patient group will approach the control group in the pre-post comparison in the following endpoints: i) Behavioral change in social-cognitive paradigms: a) Prisoner's Dilemma Game b) Probabilistic Decision Task c) Social Memory Task ii) fMRI - iomarkers identified from the above mentioned experimental paradigms iii) Clinical and cognitive scales 2) Both groups (patients and controls) are expected to benefit from the intervention in the above mentioned endpoints

—

Countries

Germany

Contacts

Public ContactKatrin Leinweber

Universitätsklinikum Gießen und Marburg, Standort Marburg

katrin.leinweber@staff.uni-marburg.de06421 5865200

Outcome results

None listed

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