MedDataX Logo

Psychological Intervention for Relapse Prevention in First Episode Schizophrenia

NCT ID: NCT00161408

Last Updated: 2005-09-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

106 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-12-31

Study Completion Date

2005-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Schizophrenic Disorders

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

schizophrenia, first episode, cognitive behavioural therapy, psychoeducation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

cognitive behavioural therapy

Intervention Type BEHAVIORAL

psychoeducation

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Hospital Tuebingen

OTHER

Sponsor Role lead

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Stefan Klingberg, PD Dr. phil. Dipl. Psych.

Role: PRINCIPAL_INVESTIGATOR

University Hospital Tuebingen

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Department of Psychiatry and Psychotherapy, University of Bonn

Bonn, , Germany

Site Status

Department of Psychiatry and Psychotherapy, University of Cologne

Cologne, , Germany

Site Status

Department of Psychiatry and Psychotherapy, University of Duesseldorf

Düsseldorf, , Germany

Site Status

Department of Psychiatry and Psychotheray, University of Muenchen

München, , Germany

Site Status

Department of Psychiatry and Psychotherapy, University of Tuebingen

Tübingen, , Germany

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Germany

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

01GI9932-P2223

Identifier Type: -

Identifier Source: org_study_id