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Completed

NCT Number: NCT01282307

Improving Insight in Patients Diagnosed With Schizophrenia

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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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Psychiatry in Region North Jutland

Aalborg, North Jutland, 9000, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Guided Self-Determination GSD

Behavioral

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.

Primary outcomes

  1. changes in cognitive insight over time

    Time frame: baseline, 3,6 and 12 month

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

Secondary outcomes

  1. Changes in Clinical insight over time

    Time frame: baseline, 3,6,12 month

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

  2. changes in various domains of recovery over time

    Time frame: baseline, 3,6,12 month

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

  3. changes in self-esteem over time

    Time frame: baseline, 3,6,12 month

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

  4. changes in psychopathology over time

    Time frame: baseline, 3,6,12 month

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

  5. changes of social function over time

    Time frame: baseline, 3,6,12 month

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

  6. Therapeutic relationship

    Time frame: 12 month

    Therapeutic relationship is measured by STAR - "Scale to assess Therapeutic Relationship in Community Mental Health Care" patient version

  7. Therapeutic relationship

    Time frame: 12 month

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

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • Aalborg Psychiatric Hospital

Registry information

Official study title

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

Acronym: GEBRCT

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
Jan 24, 2011
Registry last updated
Aug 14, 2012

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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