SchizophreniaNCT00885716
A Shared Decision Making Training for Inpatients With Schizophrenia
A study testing patient training in shared decision making and cognitive training in people with Schizophrenia and Schizoaffective Disorder, run by Technical University of Munich at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Schizophrenia, Schizoaffective Disorder
- What is being tested?
- patient training in shared decision making and cognitive training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteGermany
- Study dates
- May 2009to Jun 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- poor German language skills
Trial locations and contacts
1 site in 1 country.
Germany1 site
Klinik und Poliklinik für Psychiatrie und Psychotherapie, Technische Universität München
München
About this study
Official title: Shared Decision Making: Ein Kommunikationstraining für Patienten Mit Schizophrenie
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.
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Being tested
- patient training in shared decision making, cognitive training
- Medical subject headings
- Schizophrenia, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
patient training in shared decision makingBehavioural
cognitive trainingBehavioural
| Study group | Role | What they receive |
|---|---|---|
| communication skills training | Experimental | group training in shared decision making. Receives: Behavioral: patient training in shared decision making |
| cognitive training | Active comparator | standard group training of cognitive skills (Konzentrationstraining) Receives: Behavioral: cognitive training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decision Self Efficacy
Measured: post intervention
Secondary outcomes (3)
Adherence to medication
Measured: 6 months post intervention
Participation preferences
Measured: post intervention
Treatment satisfaction
Measured: post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2009 (estimated)
- Study startMay 2009
- Primary completionJun 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Technical University of MunichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technical University of Munich
- Sponsor type
- University, hospital or other
- Collaborators
- The German-Israeli Foundation for Scientific Research and Development
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00885716
- Sponsor's protocol ID
- GIF2168-1764.1
- Status last verified
- Jun 2010
- First submitted
- 20 Apr 2009
- Last updated
- 9 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 21969650
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shared Decision Making: Ein Kommunikationstraining für Patienten Mit Schizophrenie
- ClinicalTrials.gov ID
- NCT00885716
- Acronym / sponsor ID
- GIF2168-1764.1
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Technical University of MunichUniversity, hospital or other
- Collaborators
- The German-Israeli Foundation for Scientific Research and Development
- Study start
- May 2009
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 22 Apr 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| communication skills training | Experimental | Behavioral: patient training in shared decision makinggroup training in shared decision making. |
| cognitive training | Active comparator | Behavioral: cognitive trainingstandard group training of cognitive skills (Konzentrationstraining) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- poor German language skills
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| patient training in shared decision making | Behavioural | communication skills training |
| cognitive training | Behavioural | cognitive training |
Primary outcome
Decision Self Efficacy
Time frame: post intervention
3 secondary outcomes
Adherence to medication
Time frame: 6 months post intervention
Participation preferences
Time frame: post intervention
Treatment satisfaction
Time frame: post intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2025.
- Derived from this study: PubMed 21969650Hamann 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing patient training in shared decision making and cognitive training in people with Schizophrenia and Schizoaffective Disorder, run by Technical University of Munich at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decision Self Efficacy (time frame: post intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00885716, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2025.