Clinical trial NCT01282307: Improving Insight in Patients Diagnosed With Schizophrenia
Official title: Meaningful Change With the Method Guided Self-Determination - a Randomised Controlled Study for Patients Diagnosed With Schizophrenia.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Aalborg Psychiatric Hospital
First posted: 2011-01-24
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: changes in cognitive insight over time
timeFrame: baseline, 3,6 and 12 month
Secondary outcomes:
measure: Changes in Clinical insight over time
timeFrame: baseline, 3,6,12 month
measure: changes in various domains of recovery over time
timeFrame: baseline, 3,6,12 month
measure: changes in self-esteem over time
timeFrame: baseline, 3,6,12 month
measure: changes in psychopathology over time
timeFrame: baseline, 3,6,12 month
measure: changes of social function over time
timeFrame: baseline, 3,6,12 month
measure: Therapeutic relationship
timeFrame: 12 month
measure: Therapeutic relationship
timeFrame: 12 month
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Psychiatry in Region North Jutland
state: North Jutland
Study officials:
affiliation: Unit for Psychiatric Research, Aalborg Psychiatric Hospital
name: Rikke Jørgensen, MSN
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.