Psychotic DisordersPhase 2mCBTNCT00465920
Development and Pilot Evaluation of Modified Cognitive Behavioural Therapy for Adolescents With Early Onset Psychosis
A Phase 2 study testing modified cognitive behavioural therapy (mCBT) in people with Psychotic Disorders and Schizophrenia, run by University of Cologne at 1 site in Germany.
Trial summary
In the last decade cognitive behavioural therapy (CBT) approaches for patients with schizophrenia have been developed, which where especially designed to reduce severity of positive symptoms, readmission rates, treatment non-compliance and disability. Read more about this study
- Who is it for?
- Ages 14 to 18 years
- Conditions the study is for
- Psychotic Disorders, Schizophrenia, Schizoaffective Disorder
- What is being tested?
- modified cognitive behavioural therapy (mCBT)
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 42 participants
- Where
- 1 siteGermany
- Study dates
- May 2007to Apr 2010
- Phase
- Phase 2
- 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 14 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Schizophrenia, schizophreniform or schizoaffective disorder (DSM IV 295.1- .9), delusional disorder (DSM IV 297.1)
- Score of 4 or more on one of the PANSS-items P1, P3, G9
- Positive psychotic symptoms for 3 months or more
- Age between 14 and 18
- Fluently German speaking
Who cannot join
- Diagnosis of delirium, dementia, amnestic or other cognitive disorder, psychiatric disorders due to a somatic factor or related to psychotropic substances according to DSM IV; diseases of the central nervous system
- Alcohol- or drug dependence according to DSM IV
- Verbal IQ < 80
- Travel time to the study centre of more than 1 hour
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Department of Psychiatry University Cologne
Cologne, North Rhine-Westphalia, 50937
Andreas Bechdolf, PD Dr., +49 221 478 4825, andreas.bechdolf@uk-koeln.de
Bettina Pohlmann, Dr., +49 221 478 3870, bettina.pohlmann@uk-koeln.de
About this study
In the last decade cognitive behavioural therapy (CBT) approaches for patients with schizophrenia have been developed, which where especially designed to reduce severity of positive symptoms, readmission rates, treatment non-compliance and disability. Although CBT addresses the key problems of early onset psychoses (EOP)treatment and first evaluations of CBT in adults with schizophrenia are promising, no experience with CBT in adolescents with EOP are available. Therefore the present study is conducted to develop a modified CBT (mCBT) for adolescents with EOP, to explore its acceptance and feasibility and to provide data for a realistic estimation of achievable effect size. Patients are randomized to receive either mCBT+TAU or TAU over a 9 month period. mCBT is an individual outpatient treatment of 20 session and 5 psychoeducational sessions with parents. Follow-ups for two years every 6 months are planned.
- Conditions
- Psychotic Disorders, Schizophrenia, Schizoaffective Disorder, Delusional Disorder, Schizophreniform Disorder
- Being tested
- modified cognitive behavioural therapy (mCBT)
- Keywords
- schizophrenia, cognitive behavioural therapy, early onset psychosis, Psychotic disorders (schizophrenia, schizoaffective disorder, delusional disorder, schizophreniform disorder according to DSM IV) in adolescents
- Medical subject headings
- Psychotic Disorders, Schizophrenia, Schizophrenia, Paranoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
modified cognitive behavioural therapy (mCBT)Behavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
PANSS positive syndrome (sum of items P1-P7), assessed during the treatment phase (9 month) monthly and during the follow-up phase (2 years) every 6 months
Secondary outcomes (4)
additional symptom ratings (PSYRATS)
social functioning (GAF)
illness related events (suicide, suicide attempts, rehospitalisation, severe depressive symptom exacerbation)
quality of life (MSLQ)assessed monthly during the treatment phase (9 months) and every 6 months during the follow-up phase (2 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2007 (estimated)
- Study startMay 2007
- Study completionApr 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychotic DisordersStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Cologne
- Sponsor type
- University, hospital or other
- Collaborators
- Goethe University, University Hospital Tuebingen
- Investigators
- Andreas Bechdolf, PD Dr., Principal investigator, University of Cologne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00465920
- Sponsor's protocol ID
- 01GV0619
- Acronym
- mCBT
- Status last verified
- Feb 2009
- First submitted
- 25 Apr 2007
- Last updated
- 20 Feb 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Pilot Evaluation of Modified Cognitive Behavioural Therapy for Adolescents With Early Onset Psychosis
- ClinicalTrials.gov ID
- NCT00465920
- Acronym / sponsor ID
- mCBT / 01GV0619
- Conditions
- Psychotic Disorders, Schizophrenia, Schizoaffective Disorder, Delusional Disorder, Schizophreniform Disorder
- Keywords
- schizophrenia, cognitive behavioural therapy, early onset psychosis, Psychotic disorders (schizophrenia, schizoaffective disorder, delusional disorder, schizophreniform disorder according to DSM IV) in adolescents
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- University of CologneUniversity, hospital or other
- Collaborators
- Goethe University, University Hospital Tuebingen
- Study start
- May 2007
- Study completion
- Apr 2010 (estimated)
- First posted
- 27 Apr 2007 (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.
In the last decade cognitive behavioural therapy (CBT) approaches for patients with schizophrenia have been developed, which where especially designed to reduce severity of positive symptoms, readmission rates, treatment non-compliance and disability. Although CBT addresses the key problems of early onset psychoses (EOP)treatment and first evaluations of CBT in adults with schizophrenia are promising, no experience with CBT in adolescents with EOP are available. Therefore the present study is conducted to develop a modified CBT (mCBT) for adolescents with EOP, to explore its acceptance and feasibility and to provide data for a realistic estimation of achievable effect size. Patients are randomized to receive either mCBT+TAU or TAU over a 9 month period. mCBT is an individual outpatient treatment of 20 session and 5 psychoeducational sessions with parents. Follow-ups for two years every 6 months are planned.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 14 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Schizophrenia, schizophreniform or schizoaffective disorder (DSM IV 295.1- .9), delusional disorder (DSM IV 297.1)
- Score of 4 or more on one of the PANSS-items P1, P3, G9
- Positive psychotic symptoms for 3 months or more
- Age between 14 and 18
- Fluently German speaking
Key exclusion criteria (4 listed)
- Diagnosis of delirium, dementia, amnestic or other cognitive disorder, psychiatric disorders due to a somatic factor or related to psychotropic substances according to DSM IV; diseases of the central nervous system
- Alcohol- or drug dependence according to DSM IV
- Verbal IQ < 80
- Travel time to the study centre of more than 1 hour
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 |
|---|---|---|
| modified cognitive behavioural therapy (mCBT) | Behavioural | – |
Primary outcome
PANSS positive syndrome (sum of items P1-P7), assessed during the treatment phase (9 month) monthly and during the follow-up phase (2 years) every 6 months
4 secondary outcomes
additional symptom ratings (PSYRATS)
social functioning (GAF)
illness related events (suicide, suicide attempts, rehospitalisation, severe depressive symptom exacerbation)
quality of life (MSLQ)assessed monthly during the treatment phase (9 months) and every 6 months during the follow-up phase (2 years)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2009.
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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, PD Dr. principal investigator
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 2 study testing modified cognitive behavioural therapy (mCBT) in people with Psychotic Disorders and Schizophrenia, 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 5 inclusion and 4 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 20 Feb 2009. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Contact Andreas Bechdolf, PD Dr. (+49 221 478 4825, andreas.bechdolf@uk-koeln.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PANSS positive syndrome (sum of items P1-P7), assessed during the treatment phase (9 month) monthly and during the follow-up phase (2 years) every 6 months. 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 20 Feb 2009.