Psychiatry in Region North Jutland
Aalborg, North Jutland, 9000, Denmark
NCT Number: NCT01282307
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.
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Notify Me18 year–70 year
All sexes
Interventional
Not applicable
Aalborg, North Jutland, 9000, Denmark
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: baseline, 3,6 and 12 month
Cognitive insight is measured by the selvrating questionnaire Beck Cognitive Insight Scale (BCIS).
Time frame: baseline, 3,6,12 month
Clinical insight is measured by the self-rating questionnaire "Birchwood Insight Scale"
Time frame: baseline, 3,6,12 month
recovery is measured by the self-rating questionnaire "Recovery Assessment Scale"
Time frame: baseline, 3,6,12 month
self-esteem is measured by the self-rating questionnaire "Rosenberg self-esteem scale"
Time frame: baseline, 3,6,12 month
Psychopathology is measured by the PANSS - "Positive and Negative Symptom Scale"
Time frame: baseline, 3,6,12 month
Social function is measured by GAF - "Global Assessment Scale"
Time frame: 12 month
Therapeutic relationship is measured by STAR - "Scale to assess Therapeutic Relationship in Community Mental Health Care" patient version
Time frame: 12 month
Therapeutic relationship is measured by HAS - "Helping Alliance Scale"
University of Aarhus
Other
Meaningful Change With the Method Guided Self-Determination - a Randomised Controlled Study for Patients Diagnosed With Schizophrenia.
Acronym: GEBRCT
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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