MedPath

Improving Insight in Patients Diagnosed With Schizophrenia

Not Applicable
Completed
Conditions
Schizophrenia
Interventions
Behavioral: Guided Self-Determination GSD
Registration Number
NCT01282307
Lead Sponsor
University of Aarhus
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
101
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

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Method Guided Self-DeterminationGuided Self-Determination GSDThe 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.
Primary Outcome Measures
NameTimeMethod
changes in cognitive insight over timebaseline, 3,6 and 12 month

Cognitive insight is measured by the selvrating questionnaire Beck Cognitive Insight Scale (BCIS).

Secondary Outcome Measures
NameTimeMethod
Changes in Clinical insight over timebaseline, 3,6,12 month

Clinical insight is measured by the self-rating questionnaire "Birchwood Insight Scale"

changes in various domains of recovery over timebaseline, 3,6,12 month

recovery is measured by the self-rating questionnaire "Recovery Assessment Scale"

changes in self-esteem over timebaseline, 3,6,12 month

self-esteem is measured by the self-rating questionnaire "Rosenberg self-esteem scale"

changes in psychopathology over timebaseline, 3,6,12 month

Psychopathology is measured by the PANSS - "Positive and Negative Symptom Scale"

changes of social function over timebaseline, 3,6,12 month

Social function is measured by GAF - "Global Assessment Scale"

Therapeutic relationship12 month

Therapeutic relationship is measured by HAS - "Helping Alliance Scale"

Trial Locations

Locations (1)

Psychiatry in Region North Jutland

🇩🇰

Aalborg, North Jutland, Denmark

© Copyright 2025. All Rights Reserved by MedPath