SchizophreniaPhase 3NCT00204087
Psychological Intervention for Persons in the Early Initial Prodromal State
A Phase 3 study testing Cognitive behavioral therapy (CBT) and Supportive Counselling (SC) in people with Schizophrenia and Psychosis, run by University of Cologne at 1 site in Germany.
Trial summary
The purpose of this randomized controlled trial is to develop a cognitive behavioral therapy (CBT) for persons with at risk mental states in the early initial prodromal state and to evaluate CBT in comparison to supportive counselling (SC).It is hypothesized that CBT is more effective than SC on transition to… Read more about this study
- Who is it for?
- Ages 17 to 36 years
- Conditions the study is for
- Schizophrenia, Psychosis
- What is being tested?
- Cognitive behavioral therapy (CBT) and Supportive Counselling (SC)
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 126 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2001to Jun 2005
- Phase
- Phase 3
- 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 17 to 36 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- General criteria
- Age between 17 and 36 years
- male or female, in- or outpatients
- written informed consent, for patients below 18 years also signed by their parents
- Special criteria (presented within the last three months prior to the study)
- Self-experienced neuropsychological deficits (basic symptoms)
Show all 20Show fewer
- Thought interferences
- Compulsory like perseverance of thoughts
- Thought pressure
- Thought blockages
- Disturbances of receptive language, either heard or read
- Decreased ability to discriminate between ideas and perception, fantasy and true memories
- Unstable ideas of reference (subject-centrism)
- Derealisation
- Visual perceptual disturbances (blurred vision, transitory blindness, partial seeing, hypersensitivity of light, etc..)
- Acoustic perceptual disturbances (hypersensitivity to sounds or noise (hypersensitivity to sounds or noise, acoasms, etc.) AND/OR
- Reduction in the Global Assessment of Functioning Score (DSM IV) of at least 30 points (within the past year) and at least one of the following risk factors:
- First-degree relative with a lifetime-diagnosis of schizophrenia or
- a schizophrenia spectrum disorder
- Pre-or perinatal complications
Who cannot join
- Attenuated or transient positive symptomes
- Present or past diagnosis of a schizophrenic, schizophreniform, schizoaffective, delusional or bipolar according to DSM IV
- Present or past diagnosis a brief psychotic disorder according to DSM IV with a duration of more than one week or within the last 4 weeks regardless of its duration
- Diagnosis of delirium, dementia, amnestic or other cognitive disorder, mental retardation psychiatric disorder due to a somatic factor or related to the consumption of psychotropic substances according DSM IV
- Alcohol- or drug abuse within the last three months prior to inclusion according to DSM IV
- Deases of the central nervous system (inflammatory, traumatic, epilepsy etc.)
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Psychiatry and Psychotherapy, University of Cologne
Cologne, North Rhine-Westphalia, 50924
About this study
Official title: Psychological Intervention for Persons at Risk of Psychosis in the Early Initial Prodromal State
The purpose of this randomized controlled trial is to develop a cognitive behavioral therapy (CBT) for persons with at risk mental states in the early initial prodromal state and to evaluate CBT in comparison to supportive counselling (SC).It is hypothesized that CBT is more effective than SC on transition to subthreshold psychosis, psychosis and schizophrenia as well as on prodromal symptoms and social adjustment.
Read the detailed description
Several studies indicated that self-perceived cognitive thought and perception deficits (basic symptoms), negative symptoms, anxiety, depressive symptoms and social stagnation or social decline are usually present years before the first episode of schizophrenia appears. It is also known that delayed treatment of schizophrenia correlates with a poor prognosis, low compliance and high family burden. As consequence of these findings, for the first time we developed a cognitive behavioral therapy (CBT) for persons at risk for psychosis in the early initial prodromal state. The early initial prodromal state was defined by the presence of self-perseived neuropsychological deficits, which were found to be predictive for transition to psychosis and by the presence of clinical relevant decline of functioning in combination with that of clinical management (CM). Is CBT more effective than CM with regard to the three aims of intervention 1. transition to psychosis, 2. improvement of prodromal symptoms, 3. prevention of social decline/stagnation, ? A randomized controlled trail is used to compare the efficacy of CBT with that of supportive counselling (SC). Patients are randomized to receive either CBT or SC over a 12 months period. CBT comprises of individual and group therapy as well as cognitive remediation and psychoeducation for key persons. SC should provide regular supportive contacts for the patient. No CBT strategies are allowed to be systematically applied in SC.
- Conditions
- Schizophrenia, Psychosis
- Being tested
- Cognitive behavioral therapy (CBT), Supportive Counselling (SC)
- Keywords
- Schizophrenia, Psychosis, Prodrome, Early Initial Prodromal State, Early Intervention, Cognitive Behavioral Therapy
- 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.
Cognitive behavioral therapy (CBT)Behavioural
Supportive Counselling (SC)Behavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
transition to subthreshold psychosis (and psychosis or schizophrenia)
Secondary outcomes (2)
improvement of prodromal symptoms (basic symptoms, depression, anxiety)
social adjustment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startJan 2001
- Study completionJun 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 126 participants
Sponsor and investigators
- Lead sponsor
- University of Cologne
- Sponsor type
- University, hospital or other
- Collaborators
- German Federal Ministry of Education and Research, German Research Network On Schizophrenia, Department of Psychiatry University of Bonn, Heinrich-Heine University, Duesseldorf, Ludwig-Maximilians - University of Munich
- Investigators
- Andreas Bechdolf, Dr., Study chair, Department of Psychiatry and Psychotherapy, University of Cologne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00204087
- Sponsor's protocol ID
- 01 GI 9935 - P 1.1.2
- Status last verified
- Jun 1999
- First submitted
- 12 Sep 2005
- Last updated
- 12 Jan 2006
- Results posted
- No
Publications
Wessels H, Wagner M, Kuhr K, Berning J, Putzfeld V, Janssen B, Bottlender R, Maurer K, Moller HJ, Gaebel W, Hafner H, Maier W, Klosterkotter J, Bechdolf A. Predictors of treatment response to psychological interventions in people at clinical high risk of first-episode psychosis. Early Interv Psychiatry. 2019 Feb;13(1):120-127. doi: 10.1111/eip.12460. Epub 2017 Jul 4.
PubMed 28675695Bechdolf A, Wagner M, Ruhrmann S, Harrigan S, Putzfeld V, Pukrop R, Brockhaus-Dumke A, Berning J, Janssen B, Decker P, Bottlender R, Maurer K, Moller HJ, Gaebel W, Hafner H, Maier W, Klosterkotter J. Preventing progression to first-episode psychosis in early initial prodromal states. Br J Psychiatry. 2012 Jan;200(1):22-9. doi: 10.1192/bjp.bp.109.066357. Epub 2011 Nov 10.
PubMed 22075649
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychological Intervention for Persons at Risk of Psychosis in the Early Initial Prodromal State
- ClinicalTrials.gov ID
- NCT00204087
- Acronym / sponsor ID
- 01 GI 9935 - P 1.1.2
- Conditions
- Schizophrenia, Psychosis
- Keywords
- Schizophrenia, Psychosis, Prodrome, Early Initial Prodromal State, Early Intervention, Cognitive Behavioral Therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 126 participants
- Lead sponsor
- University of CologneUniversity, hospital or other
- Collaborators
- German Federal Ministry of Education and Research, German Research Network On Schizophrenia, Department of Psychiatry University of Bonn, Heinrich-Heine University, Duesseldorf, Ludwig-Maximilians - University of Munich
- Study start
- Jan 2001
- Study completion
- Jun 2005
- First posted
- 20 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 purpose of this randomized controlled trial is to develop a cognitive behavioral therapy (CBT) for persons with at risk mental states in the early initial prodromal state and to evaluate CBT in comparison to supportive counselling (SC).It is hypothesized that CBT is more effective than SC on transition to subthreshold psychosis, psychosis and schizophrenia as well as on prodromal symptoms and social adjustment.
Detailed description
Several studies indicated that self-perceived cognitive thought and perception deficits (basic symptoms), negative symptoms, anxiety, depressive symptoms and social stagnation or social decline are usually present years before the first episode of schizophrenia appears. It is also known that delayed treatment of schizophrenia correlates with a poor prognosis, low compliance and high family burden. As consequence of these findings, for the first time we developed a cognitive behavioral therapy (CBT) for persons at risk for psychosis in the early initial prodromal state. The early initial prodromal state was defined by the presence of self-perseived neuropsychological deficits, which were found to be predictive for transition to psychosis and by the presence of clinical relevant decline of functioning in combination with that of clinical management (CM). Is CBT more effective than CM with regard to the three aims of intervention 1. transition to psychosis, 2. improvement of prodromal symptoms, 3. prevention of social decline/stagnation, ? A randomized controlled trail is used to compare the efficacy of CBT with that of supportive counselling (SC). Patients are randomized to receive either CBT or SC over a 12 months period. CBT comprises of individual and group therapy as well as cognitive remediation and psychoeducation for key persons. SC should provide regular supportive contacts for the patient. No CBT strategies are allowed to be systematically applied in SC.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 17 to 36 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (20 listed)
- General criteria
- Special criteria (presented within the last three months prior to the study)
Key exclusion criteria (6 listed)
- Attenuated or transient positive symptomes
- Present or past diagnosis of a schizophrenic, schizophreniform, schizoaffective, delusional or bipolar according to DSM IV
- Present or past diagnosis a brief psychotic disorder according to DSM IV with a duration of more than one week or within the last 4 weeks regardless of its duration
- Diagnosis of delirium, dementia, amnestic or other cognitive disorder, mental retardation psychiatric disorder due to a somatic factor or related to the consumption of psychotropic substances according DSM IV
- Alcohol- or drug abuse within the last three months prior to inclusion according to DSM IV
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 behavioral therapy (CBT) | Behavioural | – |
| Supportive Counselling (SC) | Behavioural | – |
Primary outcome
transition to subthreshold psychosis (and psychosis or schizophrenia)
2 secondary outcomes
improvement of prodromal symptoms (basic symptoms, depression, anxiety)
social adjustment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2006.
- Derived from this study: PubMed 28675695Wessels H, Wagner M, Kuhr K, Berning J, Putzfeld V, Janssen B, Bottlender R, Maurer K, Moller HJ, Gaebel W, Hafner H, Maier W, Klosterkotter J, Bechdolf A. Predictors of treatment response to psychological interventions in people at clinical high risk of first-episode psychosis. Early Interv Psychiatry. 2019 Feb;13(1):120-127. doi: 10.1111/eip.12460. Epub 2017 Jul 4.
- Derived from this study: PubMed 22075649Bechdolf A, Wagner M, Ruhrmann S, Harrigan S, Putzfeld V, Pukrop R, Brockhaus-Dumke A, Berning J, Janssen B, Decker P, Bottlender R, Maurer K, Moller HJ, Gaebel W, Hafner H, Maier W, Klosterkotter J. Preventing progression to first-episode psychosis in early initial prodromal states. Br J Psychiatry. 2012 Jan;200(1):22-9. doi: 10.1192/bjp.bp.109.066357. Epub 2011 Nov 10.
- Click here for more information about this study: Psychological intervention for persons at risk of psychosis in the early initial prodromal stateLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
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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.
Andreas Bechdolf, Dr. study chair
Department of Psychiatry and Psychotherapy, University of Cologne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cognitive behavioral therapy (CBT) and Supportive Counselling (SC) in people with Schizophrenia and Psychosis, run by University of Cologne 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 20 inclusion and 6 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 Jan 2006. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
transition to subthreshold psychosis (and psychosis or schizophrenia). 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 NCT00204087, which also lists 2 linked publications.
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 Jan 2006.