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Improving Insight in Patients Diagnosed With Schizophrenia (GEBRCT)

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University of Aarhus

Status

Completed

Conditions

Schizophrenia

Treatments

Behavioral: Guided Self-Determination GSD

Study type

Interventional

Funder types

Other

Identifiers

NCT01282307
N-20070070

Details and patient eligibility

About

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.

Enrollment

101 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

101 participants in 2 patient groups

Method Guided Self-Determination
Experimental group
Description:
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.
Treatment:
Behavioral: Guided Self-Determination GSD
Treatment as usual
No Intervention group

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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