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Improving Insight in Patients Diagnosed With Schizophrenia (GEBRCT)

This study has been completed.
Sponsor:
Collaborator:
Aalborg Psychiatric Hospital
Information provided by (Responsible Party):
Rikke Jørgensen, University of Aarhus
ClinicalTrials.gov Identifier:
NCT01282307
First received: November 19, 2010
Last updated: August 13, 2012
Last verified: August 2012

November 19, 2010
August 13, 2012
February 2008
July 2012   (final data collection date for primary outcome measure)
changes in cognitive insight over time [ Time Frame: baseline, 3,6 and 12 month ] [ Designated as safety issue: No ]
Cognitive insight is measured by the selvrating questionnaire Beck Cognitive Insight Scale (BCIS).
Same as current
Complete list of historical versions of study NCT01282307 on ClinicalTrials.gov Archive Site
  • Changes in Clinical insight over time [ Time Frame: baseline, 3,6,12 month ] [ Designated as safety issue: No ]
    Clinical insight is measured by the self-rating questionnaire "Birchwood Insight Scale"
  • changes in various domains of recovery over time [ Time Frame: baseline, 3,6,12 month ] [ Designated as safety issue: No ]
    recovery is measured by the self-rating questionnaire "Recovery Assessment Scale"
  • changes in self-esteem over time [ Time Frame: baseline, 3,6,12 month ] [ Designated as safety issue: No ]
    self-esteem is measured by the self-rating questionnaire "Rosenberg self-esteem scale"
  • changes in psychopathology over time [ Time Frame: baseline, 3,6,12 month ] [ Designated as safety issue: No ]
    Psychopathology is measured by the PANSS - "Positive and Negative Symptom Scale"
  • changes of social function over time [ Time Frame: baseline, 3,6,12 month ] [ Designated as safety issue: No ]
    Social function is measured by GAF - "Global Assessment Scale"
  • Therapeutic relationship [ Time Frame: 12 month ] [ Designated as safety issue: No ]
    Therapeutic relationship is measured by STAR - "Scale to assess Therapeutic Relationship in Community Mental Health Care" patient version
  • Therapeutic relationship [ Time Frame: 12 month ] [ Designated as safety issue: No ]
    Therapeutic relationship is measured by HAS - "Helping Alliance Scale"
Same as current
Not Provided
Not Provided
 
Improving Insight in Patients Diagnosed With Schizophrenia
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Schizophrenia
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.
  • 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.
    Intervention: Behavioral: Guided Self-Determination GSD
  • No Intervention: Treatment as usual
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
101
July 2012
July 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT01282307
N-20070070
Yes
Rikke Jørgensen, University of Aarhus
University of Aarhus
Aalborg Psychiatric Hospital
Principal Investigator: Rikke Jørgensen, MSN Unit for Psychiatric Research, Aalborg Psychiatric Hospital
University of Aarhus
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP