SchizophreniaGEBRCTNCT01282307
Improving Insight in Patients Diagnosed With Schizophrenia
A study testing Guided Self-Determination GSD in people with Schizophrenia, run by University of Aarhus at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Guided Self-Determination GSD
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 1 siteDenmark
- Study dates
- Feb 2008to Jul 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Meaningful Change With the Method Guided Self-Determination - a Randomised Controlled Study for 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.
Read more
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.
- Conditions
- Schizophrenia
- Being tested
- Guided Self-Determination GSD
- 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
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guided Self-Determination GSDBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Method Guided Self-Determination | Experimental | 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. Receives: Behavioral: Guided Self-Determination GSD |
| Treatment as usual | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in cognitive insight over time
Cognitive insight is measured by the selvrating questionnaire Beck Cognitive Insight Scale (BCIS).
Measured: baseline, 3,6 and 12 month
Secondary outcomes (7)
Changes in Clinical insight over time
Clinical insight is measured by the self-rating questionnaire "Birchwood Insight Scale"
Measured: baseline, 3,6,12 month
changes in various domains of recovery over time
recovery is measured by the self-rating questionnaire "Recovery Assessment Scale"
Measured: baseline, 3,6,12 month
changes in self-esteem over time
self-esteem is measured by the self-rating questionnaire "Rosenberg self-esteem scale"
Measured: baseline, 3,6,12 month
changes in psychopathology over time
Psychopathology is measured by the PANSS - "Positive and Negative Symptom Scale"
Measured: baseline, 3,6,12 month
changes of social function over time
Social function is measured by GAF - "Global Assessment Scale"
Measured: baseline, 3,6,12 month
Therapeutic relationship
Therapeutic relationship is measured by STAR - "Scale to assess Therapeutic Relationship in Community Mental Health Care" patient version
Measured: 12 month
Therapeutic relationship
Therapeutic relationship is measured by HAS - "Helping Alliance Scale"
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2011 (estimated)
- Study startFeb 2008
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Aalborg Psychiatric Hospital
- Responsible party
- Principal investigator, Rikke Jørgensen, University of Aarhus
- Investigators
- Rikke Jørgensen, MSN, Principal investigator, Unit for Psychiatric Research, Aalborg Psychiatric Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01282307
- Sponsor's protocol ID
- N-20070070
- Acronym
- GEBRCT
- Status last verified
- Aug 2012
- First submitted
- 19 Nov 2010
- Last updated
- 14 Aug 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Jorgensen R, Licht RW, Lysaker PH, Munk-Jorgensen P, Buck KD, Jensen SO, Hansson L, Zoffmann V. Effects on cognitive and clinical insight with the use of Guided Self-Determination in outpatients with schizophrenia: A randomized open trial. Eur Psychiatry. 2015 Jul;30(5):655-63. doi: 10.1016/j.eurpsy.2014.12.007. Epub 2015 Jan 16.
PubMed 25601635
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Meaningful Change With the Method Guided Self-Determination - a Randomised Controlled Study for Patients Diagnosed With Schizophrenia.
- ClinicalTrials.gov ID
- NCT01282307
- Acronym / sponsor ID
- GEBRCT / N-20070070
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Aalborg Psychiatric Hospital
- Study start
- Feb 2008
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 24 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Method Guided Self-Determination | Experimental | Behavioral: Guided 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. |
| Treatment as usual | No intervention | – |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Guided Self-Determination GSDThe 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. | Behavioural | Method Guided Self-Determination |
Primary outcome
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).
7 secondary outcomes
Changes in Clinical insight over time
Time frame: baseline, 3,6,12 month
changes in various domains of recovery over time
Time frame: baseline, 3,6,12 month
changes in self-esteem over time
Time frame: baseline, 3,6,12 month
changes in psychopathology over time
Time frame: baseline, 3,6,12 month
changes of social function over time
Time frame: baseline, 3,6,12 month
Therapeutic relationship
Time frame: 12 month
Therapeutic relationship
Time frame: 12 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2012.
- Derived from this study: PubMed 25601635Jorgensen R, Licht RW, Lysaker PH, Munk-Jorgensen P, Buck KD, Jensen SO, Hansson L, Zoffmann V. Effects on cognitive and clinical insight with the use of Guided Self-Determination in outpatients with schizophrenia: A randomized open trial. Eur Psychiatry. 2015 Jul;30(5):655-63. doi: 10.1016/j.eurpsy.2014.12.007. Epub 2015 Jan 16.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rikke Jørgensen, MSN principal investigator
Unit for Psychiatric Research, Aalborg Psychiatric Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Guided Self-Determination GSD in people with Schizophrenia, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes in cognitive insight over time (time frame: baseline, 3,6 and 12 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01282307, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2012.