NCT00885716

Brief Summary

Patients suffering from schizophrenia who attend the communication skills program engage more deeply in therapeutic reasoning and treatment decisions. This results in stronger preferences to participate, greater perceived involvement and better long term adherence compared to patients who do not attend the training.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
61

participants targeted

Target at P25-P50 for not_applicable schizophrenia

Timeline
Completed

Started May 2009

Shorter than P25 for not_applicable schizophrenia

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 20, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 22, 2009

Completed
9 days until next milestone

Study Start

First participant enrolled

May 1, 2009

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
Last Updated

January 9, 2025

Status Verified

June 1, 2010

Enrollment Period

1.1 years

First QC Date

April 20, 2009

Last Update Submit

January 8, 2025

Conditions

SchizophreniaSchizoaffective Disorder

Outcome Measures

Primary Outcomes (1)

  • Decision Self Efficacy

    post intervention

Secondary Outcomes (3)

  • Adherence to medication

    6 months post intervention

  • Participation preferences

    post intervention

  • Treatment satisfaction

    post intervention

Study Arms (2)

communication skills training

EXPERIMENTAL

group training in shared decision making.

Behavioral: patient training in shared decision making

cognitive training

ACTIVE COMPARATOR

standard group training of cognitive skills (Konzentrationstraining)

Behavioral: cognitive training

Interventions

patient training in shared decision makingBEHAVIORAL
communication skills training
cognitive trainingBEHAVIORAL
cognitive training

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Male and female inpatients with a diagnosis of schizophrenia/schizoaffective disorder according to ICD 10
  • between 18 and 60 years of age are eligible for the study
  • informed consent
  • inpatients

You may not qualify if:

  • poor German language skills

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Klinik und Poliklinik für Psychiatrie und Psychotherapie, Technische Universität München

München, Germany

Location

Related Publications (1)

  • Hamann J, Mendel R, Meier A, Asani F, Pausch E, Leucht S, Kissling W. "How to speak to your psychiatrist": shared decision-making training for inpatients with schizophrenia. Psychiatr Serv. 2011 Oct;62(10):1218-21. doi: 10.1176/ps.62.10.pss6210_1218.

    PMID: 21969650DERIVED

MeSH Terms

Conditions

SchizophreniaPsychotic Disorders

Interventions

Cognitive Training

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Neurological RehabilitationRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 20, 2009

First Posted

April 22, 2009

Study Start

May 1, 2009

Primary Completion

June 1, 2010

Study Completion

June 1, 2010

Last Updated

January 9, 2025

Record last verified: 2010-06

Locations

DE(1)