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
  Purpose

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.


Condition Intervention
Schizophrenia
Behavioral: Guided Self-Determination GSD

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Meaningful Change With the Method Guided Self-Determination - a Randomised Controlled Study for Patients Diagnosed With Schizophrenia.

Resource links provided by NLM:


Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • 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"


Enrollment: 101
Study Start Date: February 2008
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
No Intervention: Treatment as usual

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01282307

Locations
Denmark
Psychiatry in Region North Jutland
Aalborg, North Jutland, Denmark, 9000
Sponsors and Collaborators
University of Aarhus
Aalborg Psychiatric Hospital
Investigators
Principal Investigator: Rikke Jørgensen, MSN Unit for Psychiatric Research, Aalborg Psychiatric Hospital
  More Information

No publications provided

Responsible Party: Rikke Jørgensen, MSN ResearchNurse, PhD.Student, University of Aarhus
ClinicalTrials.gov Identifier: NCT01282307     History of Changes
Other Study ID Numbers: N-20070070
Study First Received: November 19, 2010
Last Updated: August 13, 2012
Health Authority: Denmark: Danish Dataprotection Agency
Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by University of Aarhus:
Guided Self-Determination
Improving insight
Autonomy-supportive problem solving intervention
Evaluate the effects of the method Guided Self-Determination
Improving insight in patients diagnosed with schizophrenia

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders

ClinicalTrials.gov processed this record on August 28, 2014