Shared Decision Making PLUS – a cluster-randomized trial with inpatients suffering from schizophrenia

Not Applicable

• Conditions: F20; F25; Schizophrenia; Schizoaffective disorders

• Registration Number: DRKS00010880
• Lead Sponsor: Klinikum rechts der Isar der TU München

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-08-09
• Study Completion: 2019-06-20
• Results First Posted: 2020-06-26
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 322

Inclusion Criteria

• age 18-65 years
• male and female patients
• inpatients of participating hospitals
• diagnosis of schizophrenia or schizoaffective disease (ICD 10: F20/F25)
• capable of participating in 60 min. group intervention
• being able to provide written informed consent

Exclusion Criteria

• mental retardation
• insufficient proficiency in German language to discuss treatment decisions

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
perceived inclusion in decision making (SDM-Q-9) three weeks after study entry (or at discharge if earlier)

Secondary Outcome Measures

Name	Time	Method
Therapeutic Alliance (HAS-P, three weeks after study entry)<br>Treatment satisfaction (ZUF8, three weeks after study entry)<br>Quality of life (WHO-5, EUROHIS-QOL, 0,5 and 1 year after study inclusion)<br>Unmet needs (CANSAS-P, 0,5 and 1 year after study inclusion)<br>adherence (MARS, 0,5 and 1 year after study inclusion)<br>rehospitalizations (1 year after study inclusion)