Improving Insight in Patients Diagnosed With Schizophrenia
GEBRCT
Meaningful Change With the Method Guided Self-Determination - a Randomised Controlled Study for Patients Diagnosed With Schizophrenia.
1 other identifier
interventional
101
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable schizophrenia
Started Feb 2008
Typical duration for not_applicable schizophrenia
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2008
CompletedFirst Submitted
Initial submission to the registry
November 19, 2010
CompletedFirst Posted
Study publicly available on registry
January 24, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2012
CompletedAugust 14, 2012
August 1, 2012
4.4 years
November 19, 2010
August 13, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
changes in cognitive insight over time
Cognitive insight is measured by the selvrating questionnaire Beck Cognitive Insight Scale (BCIS).
baseline, 3,6 and 12 month
Secondary Outcomes (7)
Changes in Clinical insight over time
baseline, 3,6,12 month
changes in various domains of recovery over time
baseline, 3,6,12 month
changes in self-esteem over time
baseline, 3,6,12 month
changes in psychopathology over time
baseline, 3,6,12 month
changes of social function over time
baseline, 3,6,12 month
- +2 more secondary outcomes
Study Arms (2)
Method Guided Self-Determination
EXPERIMENTALThe 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.
Treatment as usual
NO INTERVENTIONInterventions
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.
Eligibility Criteria
You may qualify if:
- 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
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Aarhuslead
- Aalborg Psychiatric Hospitalcollaborator
Study Sites (1)
Psychiatry in Region North Jutland
Aalborg, North Jutland, 9000, Denmark
Related Publications (1)
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.
PMID: 25601635DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rikke Jørgensen, MSN
Unit for Psychiatric Research, Aalborg Psychiatric Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MSN ResearchNurse, PhD.Student
Study Record Dates
First Submitted
November 19, 2010
First Posted
January 24, 2011
Study Start
February 1, 2008
Primary Completion
July 1, 2012
Study Completion
July 1, 2012
Last Updated
August 14, 2012
Record last verified: 2012-08