Schizophrenic DisordersNCT00161408
Psychological Intervention for Relapse Prevention in First Episode Schizophrenia
A study testing cognitive behavioural therapy and psychoeducation in people with Schizophrenic Disorders, run by University Hospital Tuebingen at 5 sites in Germany.
Trial summary
The study is a randomized clinical trial investigating the efficacy of a comprehensive psychological intervention for the treatment of first episode schizophrenia Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Schizophrenic Disorders
- What is being tested?
- cognitive behavioural therapy and psychoeducation
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 106 participants
- Where
- 5 sitesGermany
- Study dates
- Dec 2000to Sep 2005
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- diagnosis of schizophrenic disorder according to ICD 10: F20
- first episode
- age between 18 and 55
- willingness to give informed consent also to a double blind pharmacological treatment study
Who cannot join
- residence outside of the catchment area
- insufficient knowledge of the German language
- substance abuse or addiction as primary clinical problem
- serious physical illness
- organic brain disease
- pregnancy
- contraindications to neuroleptic treatment
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Germany5 sites
Department of Psychiatry and Psychotherapy, University of Bonn
Bonn, 53105
Department of Psychiatry and Psychotherapy, University of Cologne
Cologne, 50924
Department of Psychiatry and Psychotherapy, University of Duesseldorf
Düsseldorf, 40629
Department of Psychiatry and Psychotheray, University of Muenchen
München, 80336
Department of Psychiatry and Psychotherapy, University of Tuebingen
Tübingen, 72076
About this study
The study is a randomized clinical trial investigating the efficacy of a comprehensive psychological intervention for the treatment of first episode schizophrenia
Read the detailed description
Patients suffering from their first episode of schizophrenic disorders are randomly allocated to either a short "information centered psychoeducation" (ICP) of 8 sessions or a "cognitive behavioral treatment" (CBT). CBT includes 8 sessions of psychoeducation, 8 sessions of computer based cognitive training, 8 sessions with relatives and 20 sessions of focusing on stress management, relapse prevention and coping with persistent symptoms.
The primary endpoint is relapse at the one and two year follow up.
- Conditions
- Schizophrenic Disorders
- Being tested
- cognitive behavioural therapy, psychoeducation
- Keywords
- schizophrenia, first episode, cognitive behavioural therapy, psychoeducation
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cognitive behavioural therapyBehavioural
psychoeducationBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
relapse
Secondary outcomes (4)
quantitative measures of symptoms
social functioning
cognitive functioning
quality of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startDec 2000
- Study completionSep 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Schizophrenic DisordersStudies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 106 participants
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Investigators
- Stefan Klingberg, PD Dr. phil. Dipl. Psych., Principal investigator, University Hospital Tuebingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00161408
- Sponsor's protocol ID
- 01GI9932-P2223
- Status last verified
- Sep 2005
- First submitted
- 8 Sep 2005
- Last updated
- 12 Sep 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychological Intervention for Relapse Prevention in First Episode Schizophrenia
- ClinicalTrials.gov ID
- NCT00161408
- Acronym / sponsor ID
- 01GI9932-P2223
- Conditions
- Schizophrenic Disorders
- Keywords
- schizophrenia, first episode, cognitive behavioural therapy, psychoeducation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 106 participants
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- Dec 2000
- Study completion
- Sep 2005
- First posted
- 12 Sep 2005 (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.
The study is a randomized clinical trial investigating the efficacy of a comprehensive psychological intervention for the treatment of first episode schizophrenia
Detailed description
Patients suffering from their first episode of schizophrenic disorders are randomly allocated to either a short "information centered psychoeducation" (ICP) of 8 sessions or a "cognitive behavioral treatment" (CBT). CBT includes 8 sessions of psychoeducation, 8 sessions of computer based cognitive training, 8 sessions with relatives and 20 sessions of focusing on stress management, relapse prevention and coping with persistent symptoms.
The primary endpoint is relapse at the one and two year follow up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- diagnosis of schizophrenic disorder according to ICD 10: F20
- first episode
- age between 18 and 55
- willingness to give informed consent also to a double blind pharmacological treatment study
Key exclusion criteria (7 listed)
- residence outside of the catchment area
- insufficient knowledge of the German language
- substance abuse or addiction as primary clinical problem
- serious physical illness
- organic brain disease
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 |
|---|---|---|
| cognitive behavioural therapy | Behavioural | – |
| psychoeducation | Behavioural | – |
Primary outcome
relapse
4 secondary outcomes
quantitative measures of symptoms
social functioning
cognitive functioning
quality of life
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2005.
Related trials for Schizophrenic Disorders
RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruiting
Deep Brain Stimulation for Treatment-Resistant Schizophrenia
Treatment Resistant Disorders
Not yet recruitingObservational study
Sleep Monitoring for Early Detection of Relapse in People With Schizophrenia or Bipolar Disorder Receiving Usual Treatment
Bipolar Disorder (BD), SCHIZOPHRENIA 1 (Disorder)
Not yet recruitingPhase 1
Pharmacokinetics and Relative Bioavailability of Intranasal vs Intramuscular Olanzapine in Healthy Adult Participants
Healthy Adult Participants
Active, not recruiting
Designing and Evaluating a Classroom-Based Mental Health Programme for Adolescents.
Mental Health Promotion
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.
Stefan Klingberg, PD Dr. phil. Dipl. Psych. principal investigator
University Hospital Tuebingen
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cognitive behavioural therapy and psychoeducation in people with Schizophrenic Disorders, run by University Hospital Tuebingen at 5 sites 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 7 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: status not confirmed, as of the sponsor's last update on 12 Sep 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
Results are not available in the source record.
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?
relapse. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Sep 2005.