Improving Insight in Patients Diagnosed With Schizophrenia

Schizophrenia Clinical Trial

— GEBRCT  

Official title:

Meaningful Change With the Method Guided Self-Determination - a Randomised Controlled Study for Patients Diagnosed With Schizophrenia.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01282307
• Other study ID #: N-20070070
• Status: Completed
• Phase: N/A
• First received: November 19, 2010
• Last updated: August 13, 2012
• Start date: February 2008
• Est. completion date: July 2012

Study information

• Verified date: August 2012
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection AgencyDenmark: The Regional Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Schizophrenia

Intervention

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.

Locations

Country	Name	City	State
Denmark	Psychiatry in Region North Jutland	Aalborg	North Jutland

Sponsors (2)

Lead Sponsor	Collaborator
University of Aarhus	Aalborg Psychiatric Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Changes in Clinical insight over time	Clinical insight is measured by the self-rating questionnaire "Birchwood Insight Scale"	baseline, 3,6,12 month	No
Secondary	changes in various domains of recovery over time	recovery is measured by the self-rating questionnaire "Recovery Assessment Scale"	baseline, 3,6,12 month	No
Secondary	changes in self-esteem over time	self-esteem is measured by the self-rating questionnaire "Rosenberg self-esteem scale"	baseline, 3,6,12 month	No
Secondary	changes in psychopathology over time	Psychopathology is measured by the PANSS - "Positive and Negative Symptom Scale"	baseline, 3,6,12 month	No
Secondary	changes of social function over time	Social function is measured by GAF - "Global Assessment Scale"	baseline, 3,6,12 month	No
Secondary	Therapeutic relationship	Therapeutic relationship is measured by STAR - "Scale to assess Therapeutic Relationship in Community Mental Health Care" patient version	12 month	No
Secondary	Therapeutic relationship	Therapeutic relationship is measured by HAS - "Helping Alliance Scale"	12 month	No