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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
University of Cologne
About
Eligibility
Locations
Outcomes
Full info

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

14 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

First Posted
April 25, 2007
Last Updated
February 19, 2009
Sponsor
University of Cologne
Collaborators
Goethe University, University Hospital Tuebingen
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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

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Development and Pilot Evaluation of Modified Cognitive Behavioural Therapy for Adolescents With Early Onset Psychosis

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