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Improving Insight in Patients Diagnosed With Schizophrenia (GEBRCT)

Primary Purpose

Schizophrenia

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Guided Self-Determination GSD
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring 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

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Psychiatry in Region North Jutland

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Method Guided Self-Determination

Treatment as usual

Arm Description

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.

Outcomes

Primary Outcome Measures

changes in cognitive insight over time
Cognitive insight is measured by the selvrating questionnaire Beck Cognitive Insight Scale (BCIS).

Secondary Outcome Measures

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

Full Information

First Posted
November 19, 2010
Last Updated
August 13, 2012
Sponsor
University of Aarhus
Collaborators
Aalborg Psychiatric Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01282307
Brief Title
Improving Insight in Patients Diagnosed With Schizophrenia
Acronym
GEBRCT
Official Title
Meaningful Change With the Method Guided Self-Determination - a Randomised Controlled Study for Patients Diagnosed With Schizophrenia.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
July 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Aarhus
Collaborators
Aalborg Psychiatric Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
101 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Method Guided Self-Determination
Arm Type
Experimental
Arm Description
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.
Arm Title
Treatment as usual
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Guided Self-Determination GSD
Intervention Description
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.
Primary Outcome Measure Information:
Title
changes in cognitive insight over time
Description
Cognitive insight is measured by the selvrating questionnaire Beck Cognitive Insight Scale (BCIS).
Time Frame
baseline, 3,6 and 12 month
Secondary Outcome Measure Information:
Title
Changes in Clinical insight over time
Description
Clinical insight is measured by the self-rating questionnaire "Birchwood Insight Scale"
Time Frame
baseline, 3,6,12 month
Title
changes in various domains of recovery over time
Description
recovery is measured by the self-rating questionnaire "Recovery Assessment Scale"
Time Frame
baseline, 3,6,12 month
Title
changes in self-esteem over time
Description
self-esteem is measured by the self-rating questionnaire "Rosenberg self-esteem scale"
Time Frame
baseline, 3,6,12 month
Title
changes in psychopathology over time
Description
Psychopathology is measured by the PANSS - "Positive and Negative Symptom Scale"
Time Frame
baseline, 3,6,12 month
Title
changes of social function over time
Description
Social function is measured by GAF - "Global Assessment Scale"
Time Frame
baseline, 3,6,12 month
Title
Therapeutic relationship
Description
Therapeutic relationship is measured by STAR - "Scale to assess Therapeutic Relationship in Community Mental Health Care" patient version
Time Frame
12 month
Title
Therapeutic relationship
Description
Therapeutic relationship is measured by HAS - "Helping Alliance Scale"
Time Frame
12 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rikke Jørgensen, MSN
Organizational Affiliation
Unit for Psychiatric Research, Aalborg Psychiatric Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Psychiatry in Region North Jutland
City
Aalborg
State/Province
North Jutland
ZIP/Postal Code
9000
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
25601635
Citation
Jorgensen R, Licht RW, Lysaker PH, Munk-Jorgensen P, Buck KD, Jensen SO, Hansson L, Zoffmann V. Effects on cognitive and clinical insight with the use of Guided Self-Determination in outpatients with schizophrenia: A randomized open trial. Eur Psychiatry. 2015 Jul;30(5):655-63. doi: 10.1016/j.eurpsy.2014.12.007. Epub 2015 Jan 16.
Results Reference
derived

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Improving Insight in Patients Diagnosed With Schizophrenia

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