Improving Insight in Patients Diagnosed With Schizophrenia (GEBRCT)
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|ClinicalTrials.gov Identifier: NCT01282307|
Recruitment Status : Completed
First Posted : January 24, 2011
Last Update Posted : August 14, 2012
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).
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 or disease||Intervention/treatment||Phase|
|Schizophrenia||Behavioral: Guided Self-Determination GSD||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||101 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Meaningful Change With the Method Guided Self-Determination - a Randomised Controlled Study for Patients Diagnosed With Schizophrenia.|
|Study Start Date :||February 2008|
|Actual Primary Completion Date :||July 2012|
|Actual Study Completion Date :||July 2012|
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|
- changes in cognitive insight over time [ Time Frame: baseline, 3,6 and 12 month ]Cognitive insight is measured by the selvrating questionnaire Beck Cognitive Insight Scale (BCIS).
- Changes in Clinical insight over time [ Time Frame: baseline, 3,6,12 month ]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 ]recovery is measured by the self-rating questionnaire "Recovery Assessment Scale"
- changes in self-esteem over time [ Time Frame: baseline, 3,6,12 month ]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 ]Psychopathology is measured by the PANSS - "Positive and Negative Symptom Scale"
- changes of social function over time [ Time Frame: baseline, 3,6,12 month ]Social function is measured by GAF - "Global Assessment Scale"
- Therapeutic relationship [ Time Frame: 12 month ]Therapeutic relationship is measured by STAR - "Scale to assess Therapeutic Relationship in Community Mental Health Care" patient version
- Therapeutic relationship [ Time Frame: 12 month ]Therapeutic relationship is measured by HAS - "Helping Alliance Scale"
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01282307
|Psychiatry in Region North Jutland|
|Aalborg, North Jutland, Denmark, 9000|
|Principal Investigator:||Rikke Jørgensen, MSN||Unit for Psychiatric Research, Aalborg Psychiatric Hospital|