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Improving Insight in Patients Diagnosed With Schizophrenia

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01282307
Acronym
GEBRCT
Enrollment
101
Registered
2011-01-24
Start date
2008-02-29
Completion date
2012-07-31
Last updated
2012-08-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia

Keywords

Guided Self-Determination, Improving insight, Autonomy-supportive problem solving intervention, Evaluate the effects of the method Guided Self-Determination, Improving insight in patients diagnosed with schizophrenia

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.

Interventions

BEHAVIORALGuided 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.

Sponsors

University of Aarhus
Lead SponsorOTHER
Aalborg Psychiatric Hospital
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
changes in cognitive insight over timebaseline, 3,6 and 12 monthCognitive insight is measured by the selvrating questionnaire Beck Cognitive Insight Scale (BCIS).

Secondary

MeasureTime frameDescription
Changes in Clinical insight over timebaseline, 3,6,12 monthClinical insight is measured by the self-rating questionnaire Birchwood Insight Scale
changes in various domains of recovery over timebaseline, 3,6,12 monthrecovery is measured by the self-rating questionnaire Recovery Assessment Scale
changes in self-esteem over timebaseline, 3,6,12 monthself-esteem is measured by the self-rating questionnaire Rosenberg self-esteem scale
changes of social function over timebaseline, 3,6,12 monthSocial function is measured by GAF - Global Assessment Scale
Therapeutic relationship12 monthTherapeutic relationship is measured by STAR - Scale to assess Therapeutic Relationship in Community Mental Health Care patient version
changes in psychopathology over timebaseline, 3,6,12 monthPsychopathology is measured by the PANSS - Positive and Negative Symptom Scale

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 5, 2026