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21 March 2013
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| [ Print-friendly version ] |
| Metacognitive Reflection & Insight Therapy (MERIT) |
| ISRCTN | ISRCTN16659871 |
| DOI | 10.1186/ISRCTN16659871 |
| ClinicalTrials.gov identifier | |
| EudraCT number | |
| Public title | Metacognitive Reflection & Insight Therapy (MERIT) |
| Scientific title | Metacognitive Reflection & Insight Therapy (MERIT): a randomized controlled trial |
| Acronym | N/A |
| Serial number at source | ABR 41317 |
| Study hypothesis |
The primary objective of this study is to investigate if the Metacognitive Reflection and Insight Therapy (MERIT) improves metacognitive abilities in people with schizophrenia.
The secondary objective is to investigate if improvement in metacognitive abilities leads to enhanced quality of life, better course of illness, insight, and social functioning and less depression, stigma and symptoms. |
| Lay summary |
Background and study aims
The lifetime risk of schizophrenia is generally estimated to be around 1%. 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 one’s own thoughts and emotions - The ability to think about the thoughts and emotions of others - Decentration which is the ability to understand that you are not the center of the world and people’s lives continue when you are 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 experience of symptoms. It also seems to improve the therapeutic relationship and quality of life. Dr. P.H. Lysaker has developed the Metacognitive Reflection and Insight Therapy (MERIT) which aims to improve metacognitive functioning. Initial studies show promising results. We now want to investigate this therapy in a larger study. The aims are to assess how well MERIT works and whether an improvement in metacognitive abilities leads to a better enhanced quality of life for people with psychotic disorders. Who can participate? 96 participants diagnosed with psychotic disorders and with metacognitive deficits What does the study involve? Participants will be randomly allocated to one of two groups; the intervention group (MERIT) or treatment as usual (TAU). 48 participants with psychotic disorders without metacognitive deficits will be added to the first assessment, so we can compare this group with patients with metacognitive deficits on several aspects (for example empathy and quality of life). The treatment group will receive the MERIT therapy which consists of 35-40 hours of individual therapy. In this therapy, the life story (narrative) of the patient is emphasized. Using episodes from his or her narrative, the patient is gradually challenged to perform ever more complex metacognitive acts. The control group will receive treatment as usual (TAU) and will receive the therapy when the trial is completed. What are the possible benefits and risks of participating? Assessments, each lasting 2 hours, will take place before and after treatment, with a follow-up assessment after 6 months. 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. No risks are involved for the participants. Where is the study run from? The study is run from the University in Groningen and will take place at clinical sites in the Netherlands: GGZ Friesland, GGZ Drenthe, Parnassia Den Haag, Lentis Groningen en Universitair Medisch Centrum Groningen. When is the study starting and how long is it expected to run for? The study will start in June 2013 and will run for three years. Who is funding the study? GGZ Friesland, GGZ Drenthe, Postmaster Opleidingen Psychologie (PPO) Groningen and NutsOhra Who is the main contact? Ms Marieke Pijnenborg mariekepijnenborg@hotmail.com |
| Ethics approval | Not provided at time of registration |
| Study design | Multicenter randomized controlled trial |
| Countries of recruitment | Netherlands |
| Disease/condition/study domain | Schizophrenia, metacognitive deficits |
| Participants - inclusion criteria |
1. A diagnosis of schizophrenia according to Diagnostic and Statistical Manual of Mental Disorders, 4th edition text revision (DSM-IV-TR) criteria
2. Impaired metacognitive skills 3. Being able to give informed consent 4. Men and women,18- 65 years old 5. No change in medication in the past thirty days |
| Participants - exclusion criteria |
1. Florid psychosis (mean positive symptoms <4 measured by PANSS)
2. Co-morbid neurological disorder 3. Substance dependence (not substance abuse) 4. IQ <70 |
| Anticipated start date | 01/05/2013 |
| Anticipated end date | 01/05/2015 |
| Status of trial | Ongoing |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | 96 |
| Interventions |
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.H. Lysaker. The therapy will consist of 35-40 hours of individual therapy. In this therapy, the life story (narrative) of the patient is emphasized. Using episodes from his or her narrative, the client is gradually challenged to perform ever more complex metacognitive acts. To monitor metacognitive improvement in a fashion similar to Routine Outcome Monitoring, the transcripts of psychotherapy sessions will be assessed with the Metacognitive Assessment Scale (MAS-NL).
The people in the control group will receive treatment as usual (TAU) and will receive the therapy when the trial is completed. |
| Primary outcome measure(s) |
Metacognitive functioning, which will be assessed using the Metacognitive Assessment Scale (MAS-NL)
The post-treatment assessment is ten months after the baseline assessment; the follow-up assessment is six months after the post-treatment assessment. |
| Secondary outcome measure(s) |
1. Beck Depression Inventory (BDI-II)
2. Manchester Short Assessment of Quality of Life (MANSA) 3. Internalized Stigma of Mental Illness scale (ISMI) 4. Time Use 5. PSP and SF-12 (social functioning) 6. Positive and Negative Symptom Scale (PANSS) 7. Schedule for Assessment of Insight (SAI-E) Trailmaking Test A en B 8. Digit Symbol Task (WAIS I subtest) 9. Interpersonal Reactivity Index (IRI) 10. Faux Pas test 11. Empathic Accuracy Test 12. Work Readiness Questionnaire (WORQ) 13. Clinical Impression (CGI) 14. Care consumption list (zorgconsumptielijst) The post-treatment assessment is ten months after the baseline assessment; the follow-up assessment is six months after the post-treatment assessment. |
| Sources of funding |
1. NutsOhra (Netherlands)
2. GGZ Drenthe (Netherlands) 3. Geestelijke Gezondheidszorg (GGZ), Friesland (Netherlands) 4. Postmaster Opleidingen Psychologie (PPO), Groningen (Netherlands) |
| Trial website | http://www.meritonderzoek.nl |
| Publications | |
| Contact name | Ms Marieke Pijnenborg |
| Address | Grote Kruisstraat 2/1 |
| City/town | Groningen |
| Zip/Postcode | 9712 TS |
| Country | Netherlands |
| Sponsor | University of Groningen (Netherlands) |
| Address |
Rijksuniversiteit Groningen
Faculteit GMW Grote Kruisstraat 2/1 9712 TS |
| City/town | Groningen |
| Zip/Postcode | 9712 TS |
| Country | Netherlands |
| Sponsor website: | http://www.rug.nl/ |
| Date applied | 08/01/2013 |
| Last edited | 20/03/2013 |
| Date ISRCTN assigned | 20/03/2013 |
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