NCT00204087

Brief Summary

The purpose of this randomized controlled trial is to develop a cognitive behavioral therapy (CBT) for persons with at risk mental states in the early initial prodromal state and to evaluate CBT in comparison to supportive counselling (SC).It is hypothesized that CBT is more effective than SC on transition to subthreshold psychosis, psychosis and schizophrenia as well as on prodromal symptoms and social adjustment.

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
126

participants targeted

Target at P25-P50 for phase_3 schizophrenia

Timeline
Completed

Started Jan 2001

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

January 1, 2001

Completed
4.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
Last Updated

January 12, 2006

Status Verified

June 1, 1999

First QC Date

September 12, 2005

Last Update Submit

January 10, 2006

Conditions

SchizophreniaPsychosis

Keywords

SchizophreniaPsychosisProdromeEarly Initial Prodromal StateEarly InterventionCognitive Behavioral Therapy

Outcome Measures

Primary Outcomes (1)

  • transition to subthreshold psychosis (and psychosis or schizophrenia)

Secondary Outcomes (2)

  • improvement of prodromal symptoms (basic symptoms, depression, anxiety)

  • social adjustment

Interventions

Cognitive behavioral therapy (CBT)BEHAVIORAL
Supportive Counselling (SC)BEHAVIORAL

Eligibility Criteria

Age17 Years - 36 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • General criteria
  • Age between 17 and 36 years
  • male or female, in- or outpatients
  • written informed consent, for patients below 18 years also signed by their parents
  • Special criteria (presented within the last three months prior to the study)
  • Self-experienced neuropsychological deficits (basic symptoms)
  • Thought interferences
  • Compulsory like perseverance of thoughts
  • Thought pressure
  • Thought blockages
  • Disturbances of receptive language, either heard or read
  • Decreased ability to discriminate between ideas and perception, fantasy and true memories
  • Unstable ideas of reference (subject-centrism)
  • Derealisation
  • Visual perceptual disturbances (blurred vision, transitory blindness, partial seeing, hypersensitivity of light, etc..)
  • +5 more criteria

You may not qualify if:

  • Attenuated or transient positive symptomes
  • Present or past diagnosis of a schizophrenic, schizophreniform, schizoaffective, delusional or bipolar according to DSM IV
  • Present or past diagnosis a brief psychotic disorder according to DSM IV with a duration of more than one week or within the last 4 weeks regardless of its duration
  • Diagnosis of delirium, dementia, amnestic or other cognitive disorder, mental retardation psychiatric disorder due to a somatic factor or related to the consumption of psychotropic substances according DSM IV
  • Deases of the central nervous system (inflammatory, traumatic, epilepsy etc.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Psychiatry and Psychotherapy, University of Cologne

Cologne, North Rhine-Westphalia, 50924, Germany

Location

Related Publications (2)

  • Wessels H, Wagner M, Kuhr K, Berning J, Putzfeld V, Janssen B, Bottlender R, Maurer K, Moller HJ, Gaebel W, Hafner H, Maier W, Klosterkotter J, Bechdolf A. Predictors of treatment response to psychological interventions in people at clinical high risk of first-episode psychosis. Early Interv Psychiatry. 2019 Feb;13(1):120-127. doi: 10.1111/eip.12460. Epub 2017 Jul 4.

    PMID: 28675695DERIVED

  • Bechdolf A, Wagner M, Ruhrmann S, Harrigan S, Putzfeld V, Pukrop R, Brockhaus-Dumke A, Berning J, Janssen B, Decker P, Bottlender R, Maurer K, Moller HJ, Gaebel W, Hafner H, Maier W, Klosterkotter J. Preventing progression to first-episode psychosis in early initial prodromal states. Br J Psychiatry. 2012 Jan;200(1):22-9. doi: 10.1192/bjp.bp.109.066357. Epub 2011 Nov 10.

    PMID: 22075649DERIVED

Related Links

MeSH Terms

Conditions

SchizophreniaPsychotic Disorders

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Andreas Bechdolf, Dr.

    Department of Psychiatry and Psychotherapy, University of Cologne

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 20, 2005

Study Start

January 1, 2001

Study Completion

June 1, 2005

Last Updated

January 12, 2006

Record last verified: 1999-06

Locations

DE(1)