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

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

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

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.

Detailed Summary:
Sponsor: University of Cologne

Current 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

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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)


Original Secondary Outcome: Same as current

Information By: University of Cologne

Dates:
Date Received: April 25, 2007
Date Started: May 2007
Date Completion: April 2010
Last Updated: February 19, 2009
Last Verified: February 2009