Primary objective of this study is to investigate if the Metacognitive Reflection and Insight Therapy (MERIT) improves metacognitive abilities in people with schizophrenia. Secondary objective is to examine whether improvement in metacognitive…
ID
Source
Brief title
Condition
- Schizophrenia and other psychotic disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is metacognitive functioning, which will be assessed
using the Metacognitive Assessment Scale (MAS-NL).
Secondary outcome
Depression Beck Depression Inventory-II (Beck et al., 1996)
Internalized Stigma ISMI (Ritsher et al., 2003)
Quality of Life MANSA (Priebe et al., 1999)
Social Functioning Time Use
Symptoms Positive and Negative Symptom Scale
Neurocognitive function Trailmaking test A&B
Neurocognitive function Digit Symbol Test (WAIS I)
Premorbid IQ Nederlandse Leestest voor Volwassenen (NLV)
Theory of Mind Faux Pas Task
Empathy Interpersonal Reactivity Index (IRI)
Empathy Emphatic Accuracy Test
Cost effectiveness SF-12
Cost effectiveness Zorg consumptie vragenlijst
Background summary
One percent of the total Dutch population has schizophrenia. Research has shown
deficits in Metacognitive abilities in more than half of people with
schizophrenia and association between deficits and poor course of illness.
Metacognition is the ability to think about thoughts and feelings of oneself
and others. It is a broad concept and involves several aspects:
- the ability to think about ones own thoughts and emotions;
- the ability to think about the thoughts and emotions of others;
- decentration; the ability to understand that you are not the center of the
world and peoples lives continue when your not around;
- the ability to use the three aspects above to adapt your behavior to the
circumstances.
Research has shown that improvement in Metacognitive abilities leads to
improvement in social functioning and less symptoms. It also seems to improve
the therapeutic relationship, insight and the experienced quality of life.
Dr. P. Lysaker has developed the Metacognitive Reflection and Insight Therapy
(MERIT) that aims to improve metacognitive functioning. Pilot studies show
promising results. We now want to investigate this therapy in a Randomized
Controlled Trial.
Study objective
Primary objective of this study is to investigate if the Metacognitive
Reflection and Insight Therapy (MERIT) improves metacognitive abilities in
people with schizophrenia. Secondary objective is to examine whether
improvement in metacognitive abilities leads to enhanced quality of life,
experience of symptoms, insight, social functioning, depression and work
readiness in people with psychotic disorders. We also want to investigate the
cost-effectiveness of the Metacognitive Reflection and Insight Therapy.
Study design
Multicenter randomized controlled trial.
Intervention
The treatment condition will receive the Metacognitive Reflection and Insight
Therapy (MERIT). This psychotherapy seeks to enhance the metacognitive
abilities of people with schizophrenia and is developed by dr. P. Lysaker. The
therapy is standardized with a treatment protocol. The therapy will consist of
a one hour individual therapy session per week, for ten months.
Study burden and risks
Assessments will take place before, after and six months after the therapy.
Assessment of each patient will take 2x 1,5 hours. The proposed intervention
consists of weekly individual therapy sessions of one hour. Our expectation is
that improved metacognitive skills will play an important role in the recovery
process of schizophrenia and will help patients to gain more control of their
lives.
Grote Kruisstraat 2/1
Groningen 9712 TS
NL
Grote Kruisstraat 2/1
Groningen 9712 TS
NL
Listed location countries
Age
Inclusion criteria
A diagnosis of schizophrenia or schizoaffective disorder, according to DSM-IV-TR criteria;
Impaired metacognitive skills, measured with 4 questions for the therapist and the MAS-A;
Being able to give informed consent;
18 years or older;
No change in medication in the past thirty days.
Exclusion criteria
Florid psychosis (positive symptoms <4 measured by PANSS);
co-morbid neurological disorder;
substance dependence (not substance abuse);
IQ <70.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL41317.042.13 |