Diagnosis of Schizophrenia Spectrum DisordersNCT03427580
Metacognitive and Insight Therapy for Persons With Schizophrenia (RCT MERIT)
A study testing MERIT in people with Diagnosis of Schizophrenia Spectrum Disorders, run by Bar-Ilan University, Israel at 1 site in Israel.
Trial summary
People with schizophrenia spectrum disorders are faced with significant metacognitive impairments that include difficulties in their ability to form complex representations of the self and others. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Diagnosis of Schizophrenia Spectrum Disorders
- What is being tested?
- MERIT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Mar 2018to 1 Aug 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosis of schizophrenia spectrum disorders
- Ability to provide informed consent
- Ability to read and write in Hebrew
Who cannot join
- No co-morbid nuerological condition
- No hospitalization in the last 6 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Metacognitive and Insight Therapy (MERIT) for Persons With Schizophrenia: Assessment of Session by Session Progress and Outcome.
People with schizophrenia spectrum disorders are faced with significant metacognitive impairments that include difficulties in their ability to form complex representations of the self and others. These impairments are associated with increased symptoms, impaired subjective self-experiences, and lower social functioning. As a result, interventions that enhance metacognitive capacity have been recently developed and explored. One of these interventions is Metacognitive Reflection and Insight Therapy (MERIT; Lysaker et al., 2014). MERIT is an integrative model of psychotherapy that seeks to promote holistic metacognitive capacity and consequently increase a positive sense of agency and sense of meaning in life among clients with schizophrenia. Several case studies (including in Bar-Ilan's community clinic), as well as a recent pilot study, showed increased metacognitive abilities and a decrease in symptoms following MERIT. The current study will explore both the effectiveness and the change mechanisms that underlie MERIT interventon among clients diagnosed with schizophrenia spectrum disorders, via both pre- and post-measures of the intervention's outcome and session-by-session estimations of the therapeutic process.
- Being tested
- MERIT
- Keywords
- Schizophrenia, Psychotherapy, Metacognitive abilities, Session by session assessment, Outcome
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MERITBehavioural
Metacognitive Reflection and Insight Therapy
| Study group | Role | What they receive |
|---|---|---|
| treatment group | Experimental | Not described Receives: Behavioral: MERIT |
| delayed treatment control group | Experimental | Not described Receives: Behavioral: MERIT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metacognition Assessment Scale-Abbreviated (MAS-A)
The Metacognition Assessment Scale-Abbreviated (MAS-A) is a rating scale used to assess metacognitive abilities in individuals, particularly those with psychiatric conditions. The scale consists of four domains that reflect one's ability to understand different mental phenomena and use this understanding in order to cope with psychological challenges.
Higher scores indicate a higher complexity of functions and ideas in each domain, i.e. higher values represent a better outcome. The four scales/domains:
- self-reflectivity (min 1 to max 9) ;
- understanding of the other's mind (min 1 to max 7) ;
- decentration (min 1 to max 3) ;
- mastery (min 1 to max 9). The total score is the sum of the ratings in each subscale. Thus, the total score can be ranged from 4 (min) to 28 (max), when higher values represent a better outcome.
Measured: Prior to the begining of the therapy (baseline, pre-treatment), and again at the end of the therapy (six months later, post-treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2018
- Study start1 Mar 2018
- Primary completion1 Mar 2021
- Study completion1 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diagnosis of Schizophrenia Spectrum DisordersStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bar-Ilan University, Israel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ilanit Hasson-Ohayon, Bar-Ilan University, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03427580
- Sponsor's protocol ID
- MERIT
- Status last verified
- Mar 2025
- First submitted
- 4 Feb 2018
- Last updated
- 6 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lavi-Rotenberg A, Bar-Kalifa E, de Jong S, Igra L, Lysaker PH, Hasson-Ohayon I. Elements that enhance therapeutic alliance and short-term outcomes in metacognitive reflection and insight therapy: A session-by-session assessment. Psychiatr Rehabil J. 2020 Dec;43(4):318-326. doi: 10.1037/prj0000415. Epub 2020 Apr 9.
PubMed 32271073
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metacognitive and Insight Therapy (MERIT) for Persons With Schizophrenia: Assessment of Session by Session Progress and Outcome.
- ClinicalTrials.gov ID
- NCT03427580
- Acronym / sponsor ID
- MERIT
- Keywords
- Schizophrenia, Psychotherapy, Metacognitive abilities, Session by session assessment, Outcome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Bar-Ilan University, IsraelUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 1 Mar 2021 (actual)
- Study completion
- 1 Aug 2021 (actual)
- First posted
- 9 Feb 2018 (actual)
- Results
- Posted 6 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
People with schizophrenia spectrum disorders are faced with significant metacognitive impairments that include difficulties in their ability to form complex representations of the self and others. These impairments are associated with increased symptoms, impaired subjective self-experiences, and lower social functioning. As a result, interventions that enhance metacognitive capacity have been recently developed and explored. One of these interventions is Metacognitive Reflection and Insight Therapy (MERIT; Lysaker et al., 2014). MERIT is an integrative model of psychotherapy that seeks to promote holistic metacognitive capacity and consequently increase a positive sense of agency and sense of meaning in life among clients with schizophrenia. Several case studies (including in Bar-Ilan's community clinic), as well as a recent pilot study, showed increased metacognitive abilities and a decrease in symptoms following MERIT. The current study will explore both the effectiveness and the change mechanisms that underlie MERIT interventon among clients diagnosed with schizophrenia spectrum disorders, via both pre- and post-measures of the intervention's outcome and session-by-session estimations of the therapeutic process.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| treatment group | Experimental | Behavioral: MERIT |
| delayed treatment control group | Experimental | Behavioral: MERIT |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Diagnosis of schizophrenia spectrum disorders
- Ability to provide informed consent
- Ability to read and write in Hebrew
Key exclusion criteria (2 listed)
- No co-morbid nuerological condition
- No hospitalization in the last 6 months
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 |
|---|---|---|
| MERITMetacognitive Reflection and Insight Therapy | Behavioural | delayed treatment control group, treatment group |
Primary outcome
Metacognition Assessment Scale-Abbreviated (MAS-A)
Time frame: Prior to the begining of the therapy (baseline, pre-treatment), and again at the end of the therapy (six months later, post-treatment)
The Metacognition Assessment Scale-Abbreviated (MAS-A) is a rating scale used to assess metacognitive abilities in individuals, particularly those with psychiatric conditions. The scale consists of four domains that reflect one's ability to understand different mental phenomena and use this understanding in order to cope with psychological challenges. Higher scores indicate a higher complexity of functions and ideas in each domain, i.e. higher values represent a better outcome. The four scales/domains: 1. self-reflectivity (min 1 to max 9) ; 2. understanding of the other's mind (min 1 to max 7) ; 3. decentration (min 1 to max 3) ; 4. mastery (min 1 to max 9). The total score is the sum of the ratings in each subscale. Thus, the total score can be ranged from 4 (min) to 28 (max), when higher values represent a better outcome.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32271073Lavi-Rotenberg A, Bar-Kalifa E, de Jong S, Igra L, Lysaker PH, Hasson-Ohayon I. Elements that enhance therapeutic alliance and short-term outcomes in metacognitive reflection and insight therapy: A session-by-session assessment. Psychiatr Rehabil J. 2020 Dec;43(4):318-326. doi: 10.1037/prj0000415. Epub 2020 Apr 9.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MERIT in people with Diagnosis of Schizophrenia Spectrum Disorders, run by Bar-Ilan University, Israel at 1 site in Israel.
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 3 inclusion and 2 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 6 Mar 2025. 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 Israel. 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?
Yes. Results are posted in the registry (first posted 6 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Metacognition Assessment Scale-Abbreviated (MAS-A) (time frame: Prior to the begining of the therapy (baseline, pre-treatment), and again at the end of the therapy (six months later, post-treatment)). 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 NCT03427580, 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 6 Mar 2025.