Anomalous Self-Experience in First Episode Psychosis - A Six-Year Follow-Up Study

April 26, 2017 updated by: Sykehuset Innlandet HF
The objective of this study is to explore the longitudinal course of self-disturbances (SD) in schizophrenia. The main aim of the study is to investigate, in a 6-7-year follow-up of a representative sample of patients with first-episode schizophrenia, bipolar disorder and other psychoses. The overall aim is to expand our knowledge about the role of SDs in psychotic disorders. Increased knowledge here will aid diagnosis and treatment. The current study is a seven year follow-up of this representative cohort, with baseline measures of SDs and a comprehensive clinical and neurocognitive assessment battery.

Study Overview

Study Type

Observational

Enrollment (Actual)

56

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Brumunddal, Norway, 2380
        • Sykehuset Innlandet HF

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients reffered to their first adequate treatment for broadly defines psychotic disorders (inkluding both schizophrenia - and bipolar Spectrum disorders) in Oppland and Hedmark counties in Norway, in 2008 - 2009 participated the base-line part of the study(E. Haug, 2012).

Description

Inclusion Criteria:

  • Patients who participated and completed base-line part of the study,
  • Patients with concurrent substance use disorder are included, but have to demonstrate at least one month without substance use, or clear signs that the psychotic disorder had started before the onset of significant substance use.

Exclusion Criteria:

  • Patients with brain injury,
  • Patients with on going substance use,
  • Unable to provide informed consent statement.
  • Not able to be interviewed.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Follow-Up Group
An earlier investigated cohort with first episode psychosis patients from two Norwegian counties. Being between 18 - 65 years old and being consecutive in- or outpatient referred to first adequate treatment for a DSM-IV diagnosis of schizophrenia, bipolar disorder, or "other psychosis".

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change From Baseline in EASE (Examination of Anomalous Self-Experience)Total Score and Subscales of EASE
Time Frame: 6 year
6 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from Baseline for Structured Clinical Interview for the DSM ( SCID-I)(DSM-IV)
Time Frame: 6 year
6 year

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Positive and negative syndrome
Time Frame: 6 year
Positive and Negative Syndrome Scale (PANSS) Total Score and Subscales of PANSS
6 year
Change From Baseline in Calgary Depression Scale Score for Schizophrenia (CDSS)
Time Frame: 6 year
6 year
Change from Baseline for Alcohol and Drug Use Disorder Identification Test (AUDIT and DUDIT)
Time Frame: 6 year
6 year
Change from Baseline for neurocognitive tests battery
Time Frame: 6 year
6 year
Change from Baseline for Global Assessment of Functioning - split Version(GAF)
Time Frame: 6 year
6 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2015

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

December 17, 2014

First Submitted That Met QC Criteria

December 19, 2014

First Posted (Estimate)

December 22, 2014

Study Record Updates

Last Update Posted (Actual)

April 27, 2017

Last Update Submitted That Met QC Criteria

April 26, 2017

Last Verified

April 1, 2017

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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