Psychological Intervention for Relapse Prevention in First Episode Schizophrenia

• Sponsor: University Hospital Tuebingen (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT00161408
• Collaborator: (none)
• Enrollment: 106
• Locations: 5
• Duration (Months): 57
• Patients Per Site: 21.2
• Patients Per Site Per Month: 0.4

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Schizophrenic Disorders	Behavioral: cognitive behavioural therapy; Behavioral: psychoeducation	N/A

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.

Study Design

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Psychological Intervention for Relapse Prevention in First Episode Schizophrenia
• Study Start Date: Dec 1, 2000
• Study Completion Date: Sep 1, 2005

Outcome Measures

Primary Outcome Measures

1. relapse []

Secondary Outcome Measures

1. quantitative measures of symptoms []

2. social functioning []

3. cognitive functioning []

4. quality of life []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: 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:

• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Psychiatry and Psychotherapy, University of Bonn	Bonn		Germany	53105
2	Department of Psychiatry and Psychotherapy, University of Cologne	Cologne		Germany	50924
3	Department of Psychiatry and Psychotherapy, University of Duesseldorf	Duesseldorf		Germany	40629
4	Department of Psychiatry and Psychotheray, University of Muenchen	Muenchen		Germany	80336
5	Department of Psychiatry and Psychotherapy, University of Tuebingen	Tuebingen		Germany	72076

Sponsors and Collaborators

• University Hospital Tuebingen

Investigators

• Principal Investigator: Stefan Klingberg, PD Dr. phil. Dipl. Psych., University Hospital Tuebingen

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00161408
• Other Study ID Numbers: 01GI9932-P2223
• First Posted: Sep 12, 2005
• Last Update Posted: Sep 12, 2005
• Last Verified: Sep 1, 2005

• Keywords provided by , ,: schizophrenia, first episode, cognitive behavioural therapy, psychoeducation
• Additional relevant MeSH terms: Schizophrenia

Study Results

No Results Posted as of Sep 12, 2005