NCT00300651

Brief Summary

The following study addresses the hypothesis that cognitive-behavioral interventions will be effective in reducing positive and negative symptoms of schizophrenia under the conditions of the German health care system. It is also hypothesized that interventions designed to reduce delusions will reduce cognitive biases and dysfunctional self-concepts.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at below P25 for phase_3 schizophrenia

Timeline
Completed

Started Mar 2006

Longer than P75 for phase_3 schizophrenia

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2006

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

March 8, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 9, 2006

Completed
3.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
Last Updated

March 9, 2006

Status Verified

March 1, 2006

First QC Date

March 8, 2006

Last Update Submit

March 8, 2006

Conditions

Keywords

Cognitive Behavioral TherapySchizophreniaCognitive BiasesEfficacy

Outcome Measures

Primary Outcomes (1)

  • Positive and Negative Syndrome Scale (PANSS)before and after treatment and at 1-year-follow-up

Secondary Outcomes (3)

  • Depression before and after treatment and at 1-year-follow-up

  • Dysfunctional Attitudes before and after treatment and at 1-year-follow-up

  • Cognitive biases (jumping to conclusions, attribution, theory of mind) before and after treatment

Interventions

Eligibility Criteria

Age16 Years - 69 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • persons with a primary diagnosis of schizophrenia, schizoaffective disorder, delusional disorder acute or in incomplete remission a value of at least 3 on delusions, P1, P3 or G9 in Positive and Negative Syndrome Scale
  • fluent in German language

You may not qualify if:

  • severe organic brain disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Philipps-Universität

Marburg, 35032, Germany

RECRUITING

Related Links

MeSH Terms

Conditions

SchizophreniaPsychotic DisordersSchizophrenia, Paranoid

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Tania M Lincoln, PhD

    Philipps-Universität Marburg, Faculty of Psychology, Section for Clinical Psychology and Psychotherapy

    PRINCIPAL INVESTIGATOR
  • Tania M Lincoln, PhD

    Philipps-Universität Marburg, Faculty of Psychology, Section for Clinical Psychology and Psychotherapy

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 8, 2006

First Posted

March 9, 2006

Study Start

March 1, 2006

Study Completion

August 1, 2009

Last Updated

March 9, 2006

Record last verified: 2006-03

Locations