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Status unknownNCT00161408Updated Sep 12, 2005

Psychological Intervention for Relapse Prevention in First Episode Schizophrenia

An interventional study of cognitive behavioural therapy and psychoeducation in Schizophrenic Disorders, sponsored by University Hospital Tuebingen. Status unknown at 5 sites in Germany. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2005-09-12.

Sponsored by University Hospital Tuebingen · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Sep 2005), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
106
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study summary

The study is a randomized clinical trial investigating the efficacy of a comprehensive psychological intervention for the treatment of first episode schizophrenia

Read the detailed description

Patients suffering from their first episode of schizophrenic disorders are randomly allocated to either a short "information centered psychoeducation" (ICP) of 8 sessions or a "cognitive behavioral treatment" (CBT). CBT includes 8 sessions of psychoeducation, 8 sessions of computer based cognitive training, 8 sessions with relatives and 20 sessions of focusing on stress management, relapse prevention and coping with persistent symptoms.

The primary endpoint is relapse at the one and two year follow up.

02

Conditions studied

  • Schizophrenic Disorders

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Keywords

  • schizophrenia, first episode, cognitive behavioural therapy, psychoeducation
03

In context

Schizophrenia

3,471 studies on the registry are indexed under Schizophrenia; 472 are open to participants now.

This study's enrollment of 106 is above the median of 70 across 2,872 interventional studies indexed under Schizophrenia.

Browse Schizophrenia studies →

Lead sponsor

University Hospital Tuebingen is the lead sponsor of 476 studies on the registry; 104 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • diagnosis of schizophrenic disorder according to ICD 10: F20
  • first episode
  • age between 18 and 55
  • willingness to give informed consent also to a double blind pharmacological treatment study

Exclusion criteria

Exclusion Criteria:

  • residence outside of the catchment area
  • insufficient knowledge of the German language
  • substance abuse or addiction as primary clinical problem
  • serious physical illness
  • organic brain disease
  • pregnancy
  • contraindications to neuroleptic treatment
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
106 participants

Interventions

  • Behavioralcognitive behavioural therapy
  • Behavioralpsychoeducation
06

What researchers measure

Primary outcomes

  1. relapse

Secondary outcomes

  1. quantitative measures of symptoms

  2. social functioning

  3. cognitive functioning

  4. quality of life

07

Study locations

5 sites
  • Department of Psychiatry and Psychotherapy, University of Bonn
    Bonn, 53105, Germany
  • Department of Psychiatry and Psychotherapy, University of Cologne
    Cologne, 50924, Germany
  • Department of Psychiatry and Psychotherapy, University of Duesseldorf
    Duesseldorf, 40629, Germany
  • Department of Psychiatry and Psychotheray, University of Muenchen
    Muenchen, 80336, Germany
  • Department of Psychiatry and Psychotherapy, University of Tuebingen
    Tuebingen, 72076, Germany
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 12, 2005, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00161408
Lead sponsor
University Hospital Tuebingen
First posted
Sep 12, 2005
Start date
Dec 2000
Completion
Sep 2005
Last update
Sep 12, 2005

Study contacts

Stefan Klingberg, PD Dr. phil. Dipl. Psych.
principal investigator · University Hospital Tuebingen
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2005. You cannot join it, but the record below documents what was studied.

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