Development and Pilot Evaluation of Modified Cognitive Behavioural Therapy for Adolescents With Early Onset Psychosis (mCBT)
Primary Purpose
Psychotic Disorders, Schizophrenia, Schizoaffective Disorder
Status
Unknown status
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
modified cognitive behavioural therapy (mCBT)
Sponsored by
About this trial
This is an interventional treatment trial for Psychotic Disorders focused on measuring schizophrenia, cognitive behavioural therapy, early onset psychosis, Psychotic disorders (schizophrenia, schizoaffective disorder, delusional disorder, schizophreniform disorder according to DSM IV) in adolescents
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Department of Psychiatry University CologneRecruiting
Outcomes
Primary Outcome Measures
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 Outcome Measures
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)
Full Information
NCT ID
NCT00465920
First Posted
April 25, 2007
Last Updated
February 19, 2009
Sponsor
University of Cologne
Collaborators
Goethe University, University Hospital Tuebingen
1. Study Identification
Unique Protocol Identification Number
NCT00465920
Brief Title
Development and Pilot Evaluation of Modified Cognitive Behavioural Therapy for Adolescents With Early Onset Psychosis
Acronym
mCBT
Official Title
Development and Pilot Evaluation of Modified Cognitive Behavioural Therapy for Adolescents With Early Onset Psychosis
Study Type
Interventional
2. Study Status
Record Verification Date
February 2009
Overall Recruitment Status
Unknown status
Study Start Date
May 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2010 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
University of Cologne
Collaborators
Goethe University, University Hospital Tuebingen
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
42 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
modified cognitive behavioural therapy (mCBT)
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
additional symptom ratings (PSYRATS)
Title
social functioning (GAF)
Title
illness related events (suicide, suicide attempts, rehospitalisation, severe depressive symptom exacerbation)
Title
quality of life (MSLQ)assessed monthly during the treatment phase (9 months) and every 6 months during the follow-up phase (2 years)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Andreas Bechdolf, PD Dr.
Phone
+49 221 478 4825
Email
andreas.bechdolf@uk-koeln.de
First Name & Middle Initial & Last Name or Official Title & Degree
Bettina Pohlmann, Dr.
Phone
+ 49 221 478 3870
Email
bettina.pohlmann@uk-koeln.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andreas Bechdolf, PD Dr.
Organizational Affiliation
University of Cologne
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Psychiatry University Cologne
City
Cologne
State/Province
North Rhine-Westphalia
ZIP/Postal Code
50937
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andreas Bechdolf, PD Dr.
Phone
+49 221 478 4825
Email
andreas.bechdolf@uk-koeln.de
First Name & Middle Initial & Last Name & Degree
Bettina Pohlmann, Dr.
Phone
+49 221 478 3870
Email
bettina.pohlmann@uk-koeln.de
First Name & Middle Initial & Last Name & Degree
Andreas Bechdolf, PD Dr.
12. IPD Sharing Statement
Learn more about this trial
Development and Pilot Evaluation of Modified Cognitive Behavioural Therapy for Adolescents With Early Onset Psychosis
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