Condition category
Mental and Behavioural Disorders
Date applied
08/01/2013
Date assigned
20/03/2013
Last edited
04/09/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English 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

Trial website

http://www.meritonderzoek.nl

Contact information

Type

Scientific

Primary contact

Ms Marieke Pijnenborg

ORCID ID

Contact details

Grote Kruisstraat 2/1
Groningen
9712 TS
Netherlands

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

ABR 41317

Study information

Scientific title

Metacognitive Reflection & Insight Therapy (MERIT): a randomized controlled trial

Acronym

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.

Ethics approval

Not provided at time of registration

Study design

Multicenter randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Schizophrenia, metacognitive deficits

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.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.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

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 measures

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.

Overall trial start date

01/05/2013

Overall trial end date

01/05/2015

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

96

Participant 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

Recruitment start date

01/05/2013

Recruitment end date

01/05/2015

Locations

Countries of recruitment

Netherlands

Trial participating centre

Grote Kruisstraat 2/1
Groningen
9712 TS
Netherlands

Sponsor information

Organisation

University of Groningen (Netherlands)

Sponsor details

Rijksuniversiteit Groningen
Faculteit GMW
Grote Kruisstraat 2/1 9712 TS
Groningen
9712 TS
Netherlands

Sponsor type

University/education

Website

http://www.rug.nl/

Funders

Funder type

Charity

Funder name

Fonds NutsOhra

Alternative name(s)

Stichting Nuts Ohra, NutsOhra Foundation, NutsOhra Fund

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

Netherlands

Funder name

GGZ Drenthe (Netherlands)

Alternative name(s)

Geestelijke Gezondheidszorg Drenthe

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

Netherlands

Funder name

Geestelijke Gezondheidszorg (GGZ), Friesland (Netherlands)

Alternative name(s)

Geestelijke Gezondheidszorg Friesland

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

Netherlands

Funder name

Postmaster Opleidingen Psychologie (PPO), Groningen (Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2014 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/24490942

Publication citations

Additional files

Editorial Notes