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MOtivation and SociAl Interactive Competence in patients with negative symptoms: Innovative cognitive behavioral therapy and neurobiological correlates (MOSAIC)

MOtivation and SociAl Interactive Competence in patients with negative symptoms: Innovative cognitive behavioral therapy and neurobiological correlates (MOSAIC) - MOSAIC-II

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00012523
Enrollment
60
Registered
2018-01-31
Start date
2016-07-13
Completion date
Unknown
Last updated
2025-10-06

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

Conditions

F20 F21 F22 F23 F24 F25

Interventions

Group 1: intervention group (innovative therapy) cognitive behavioral therapy combinig 30h individual treatment (one per week for 30 weeks) and 30h group treatment (one per week for 30 weeks) Group 2:

Sponsors

University Hospital of Tuebingen
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1) diagnosis of a psychotic disorder (all F2-diagnoses according to ICD-10) that are diagnosed using the criteria of DSM-IV and SKID 2) relevant manifestation of negative symptoms: PANSS MNS = 10 (Items N1-4, N6, G7 and G16) 3) between 18 - 65 years old 4) outpatient treatment at the time of inclusion 5) sufficient German language skills 6) normal or corrected to normal vision and hearing 7) written informed consent 8) capability to give informed consent (confirmed by an independent psychiatrist in doubtful cases) 9) if there is a legal carer, infomed consent of the carer

Exclusion criteria

Exclusion criteria: 1) substance dependence as the leading clinical problem 2) severe depressive symptoms (PANNS, G6 > 5) 3) mental retardation (IQ 11) 5) structural brain lesion 6) current psychotherapeutic treatment (including studies) 7) Exclusion criteria for MRI examinations: non-removable metal objects (i.e. cardiac pacemaker, vascular clamps, etc.), 8) pregnancy, 9) claustrophobia, 10) no consent to be informed about incidental pathological MR-findings.

Design outcomes

Primary

MeasureTime frame
PANSS Modified Negativesyndrome (Items N1-4, N6, G7, G16) after 30 weeks of treatment

Secondary

MeasureTime frame
Following 30 weeks of treatment the following secundary endpoints will be assessed: Secondary endpoints - Clinical Assessment Interview for Negative Symptoms (CAINS) - Motivation and Pleasure Scale-Self-Report (MAP-SR) - Social Skills Performance Assessment (SSPA) - Personal and Social Performance Scale (PSP) - Global Assessments of Functioning (GAF) - Lebensqualität-Fragebogen (LRI-r) - Time Budget Measure - Calgary Depression Scale for Schizophrenia (CDSS) - Positive and Negative Syndrome Scale, total score (PANSS) - Positive and Negative Syndrome Scale, pos. symptoms (PANSS)

Countries

Germany

Contacts

Public ContactKlaus Hesse

Universitätsklinik für Psychiatrie und Psychotherapie, Universität Tübingen

klaus.hesse@med.uni-tuebingen.de07071/62408

Outcome results

None listed

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