Improving Insight in Patients Diagnosed With Schizophrenia
NCT ID: NCT01282307
Last Updated: 2012-08-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
101 participants
INTERVENTIONAL
2008-02-29
2012-07-31
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
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.
Treatment as usual
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
70 Years
ALL
No
Sponsors
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Aalborg Psychiatric Hospital
OTHER
University of Aarhus
OTHER
Responsible Party
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Rikke Jørgensen
MSN ResearchNurse, PhD.Student
Principal Investigators
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Rikke Jørgensen, MSN
Role: PRINCIPAL_INVESTIGATOR
Unit for Psychiatric Research, Aalborg Psychiatric Hospital
Locations
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Psychiatry in Region North Jutland
Aalborg, North Jutland, Denmark
Countries
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References
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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.
Other Identifiers
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N-20070070
Identifier Type: -
Identifier Source: org_study_id