Improving Insight in Patients Diagnosed With Schizophrenia (GEBRCT)

August 13, 2012 updated by: Rikke Jørgensen, University of Aarhus

Meaningful Change With the Method Guided Self-Determination - a Randomised Controlled Study for Patients Diagnosed With Schizophrenia.

Background:

Rehospitalisation and discontinued treatment are common among patients with schizophrenia and is often associated with lack of insight into the illness. Improving patients' insight has been attempted through psychoeducation and standard treatment but without any considerable change. A newly developed method, Guided Self-Determination (GSD), originally developed and proved effective in difficult diabetes care has been adjusted to patients with schizophrenia. A qualitative evaluation of GSD has shown a positive influence on patients' insight into the illness.

Aim and hypotheses: The aim of the study is to evaluate the effects of the method GSD in the care of patients with schizophrenia compared to treatment as usual. The following hypotheses will be tested:

The method GSD will improve: Cognitive and clinical insight in patients, various domains of recovery, patients' self-esteem, psychopathology and social functioning.

Material and method:

The study design is a randomised controlled trial. The participants are diagnosed with schizophrenia and schizoaffective disorder, receiving treatment in 3 Assertive Outreach Teams and 3 Psychosis Teams in Region North. Participants complete four self-rating questionnaires, a demographic data sheet, an interview concerning psychopathology and an assessment of social functioning at baseline, and after 3, 6, and 12 month. All assessments will be conducted by the investigator, except for the assessment of social functioning, that will be measures by community nurses. Intervention with the method GSD will also be conducted by the community nurses but under supervision from the investigator. Fifty patients are randomly assigned to immediate receipt of individual training with the method GSD (intervention group) and 50 to a 12-month waiting list for individual training with the method GSD (control group).

Perspectives:

In mental health nursing practice in Denmark there is no tradition for empirical research as the basis of psychiatric nursing - unverified theories or general empirical consensus of good clinical practice are often the foundation of psychiatric nursing. If the method GSD proves effective in the care of patients with schizophrenia, this study contributes to an evidence based nursing intervention, which is ready for further research on implementation in mental health nursing practice.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

101

Phase

  • Not Applicable

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

  • Denmark
    • North Jutland
      • Aalborg, North Jutland, Denmark, 9000
        • Psychiatry in Region North Jutland

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 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patient's hospital record meeting the criteria for schizophrenia according to ICD-10 F.20.0-9 or schizoaffective disorder according to ICD-10 F.25.0-9
  • Age 18 - 70 years at the time of inclusion
  • Ability to understand, speak and write Danish - assessed by the community nurse
  • Informed written consent
  • receiving treatment in an assertive outreach team or psychosis team in region north in Denmark

Exclusion Criteria:

  • Previous participation with the method GSD
  • Patients who are mentally handicapped or diagnosed with any kind of dementia or an organic brain disease according to their hospital record
  • In need of an interpreter to understand, speak and write Danish
  • Withdrawal of informed consent

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Treatment as usual
Experimental: Method Guided Self-Determination
The Method Guided Self-Determination consists of 21 worksheets designed to guide patient and mental health professionals through autonomy-supportive problem solving. The worksheets are filled in by the patient before and between conversations with their community nurse over 10 sessions, approximately 1 hour a session.
Behavioral: Guided Self-Determination GSD
The method GSD consists of 21 worksheets designed to guide patient and mental health professionals through autonomy-supportive problem solving. The worksheets are filled in by the patient before and between conversations with their community nurse over 10 sessions, approximately 1 hour a session.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
changes in cognitive insight over time
Time Frame: baseline, 3,6 and 12 month
Cognitive insight is measured by the selvrating questionnaire Beck Cognitive Insight Scale (BCIS).
baseline, 3,6 and 12 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Clinical insight over time
Time Frame: baseline, 3,6,12 month
Clinical insight is measured by the self-rating questionnaire "Birchwood Insight Scale"
baseline, 3,6,12 month
changes in various domains of recovery over time
Time Frame: baseline, 3,6,12 month
recovery is measured by the self-rating questionnaire "Recovery Assessment Scale"
baseline, 3,6,12 month
changes in self-esteem over time
Time Frame: baseline, 3,6,12 month
self-esteem is measured by the self-rating questionnaire "Rosenberg self-esteem scale"
baseline, 3,6,12 month
changes in psychopathology over time
Time Frame: baseline, 3,6,12 month
Psychopathology is measured by the PANSS - "Positive and Negative Symptom Scale"
baseline, 3,6,12 month
changes of social function over time
Time Frame: baseline, 3,6,12 month
Social function is measured by GAF - "Global Assessment Scale"
baseline, 3,6,12 month
Therapeutic relationship
Time Frame: 12 month
Therapeutic relationship is measured by STAR - "Scale to assess Therapeutic Relationship in Community Mental Health Care" patient version
12 month
Therapeutic relationship
Time Frame: 12 month
Therapeutic relationship is measured by HAS - "Helping Alliance Scale"
12 month

Collaborators and Investigators

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

Sponsor

University of Aarhus

Collaborators

Aalborg Psychiatric Hospital

Investigators

  • Principal Investigator: Rikke Jørgensen, MSN, Unit for Psychiatric Research, Aalborg Psychiatric Hospital

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.

General Publications

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, 2008

Primary Completion (Actual)

July 1, 2012

Study Completion (Actual)

July 1, 2012

Study Registration Dates

First Submitted

November 19, 2010

First Submitted That Met QC Criteria

January 21, 2011

First Posted (Estimate)

January 24, 2011

Study Record Updates

Last Update Posted (Estimate)

August 14, 2012

Last Update Submitted That Met QC Criteria

August 13, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • N-20070070

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.

Clinical Trials on Schizophrenia

Clinical Trials on Guided Self-Determination GSD

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Zimbabwe

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe