ClinicalTrials.gg
CompletedNCT03427580Updated Mar 6, 2025Results posted

Metacognitive and Insight Therapy for Persons With Schizophrenia (RCT MERIT)

An interventional study of MERIT in Diagnosis of Schizophrenia Spectrum Disorders, sponsored by Bar-Ilan University, Israel. Completed at 1 site in Israel. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2025-03-06.

Sponsored by Bar-Ilan University, Israel · Not applicable, Interventional, and Supportive care

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Phase
Not applicable
Study type
Interventional
Enrollment
54
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 112 studies in Schizophrenia with a site in Israel — 3 open to participants now, 4 under way, none of them phase 3. Schizophrenia · Israel.

Enrollment
43rd of 88
54 · median 53
Started
2018
with 1 other
No phase
30 of 112
none open now
Registered
95th of 112
by date
Lead sponsor
2 of 112
Bar-Ilan University, Israel

Among the 112 studies in Schizophrenia with a site in Israel, this one is the 43rd largest by enrollment of the 88 interventional ones that give a count, is one of 2 that started in 2018, is one of 30 with no phase, and was the 95th registered.

Schizophrenia

3,567 studies on the registry are indexed under Schizophrenia; 492 are open to participants now.

Browse Schizophrenia studies →

Open to participants now

3 of the 112 studies in Schizophrenia with a site in Israel are open now. Recruiting first, the newest first:

All 3 open studies →

A study can be open while its sites in Israel have not opened yet or have stopped. Only those recruiting at a site in Israel →

Who these studies take

Of the 332 Schizophrenia studies recruiting now, 63 (19%) set no upper age limit and 258 (78%) stop at 75 or younger; 42 take children under 18; 83 take healthy volunteers.

This study: 18 Years to 50 Years · all sexes · no healthy volunteers.

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02

Study 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. 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.

03

Conditions studied

  • Diagnosis of Schizophrenia Spectrum Disorders

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Keywords

  • Schizophrenia
  • Psychotherapy
  • Metacognitive abilities
  • Session by session assessment
  • Outcome
04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Diagnosis of schizophrenia spectrum disorders
  • Ability to provide
  • Ability to read and write in Hebrew

Exclusion criteria

Exclusion Criteria:

  • No co-morbid nuerological condition
  • No hospitalization in the last 6 months
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
54 participants (actual)

Study arms

  • Experimental
    treatment group

    Behavioral: MERIT

  • Experimental
    delayed treatment control group

    Behavioral: MERIT

Interventions

  • BehavioralMERIT

    Metacognitive Reflection and Insight Therapy

06

What researchers measure

Primary outcomes

  1. 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: 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.

    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)

07

Results

Posted Mar 6, 2025

Participant flow

Participants were 35 adults diagnosed with of schizophrenia /schizoaffective disorder. Exclusion criteria: intellectual disability, neurological disorders, substance use problems, acute psychosis, and risk for suicidal behavior, based on the intake interview. The study used a delayed randomized controlled trial design to examine the therapeutic benefits of MERIT delivered in a community clinic at Bar-Ilan University.

Participant flow — Overall Study
MilestoneTreatment GroupDelayed Treatment Control Group
Started3123
Completed2114
Not completed109

Outcome measures

PrimaryMetacognition 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: 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.

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)
Reported as:
Mean · score on a scale
Metacognition Assessment Scale-Abbreviated (MAS-A)
score on a scaleDelayed Treatment Control GroupTreatment Group
Pre (treatment/waiting period)11.53 ± 3.714.22 ± 2.75
Post (treatment/waiting period)14.22 ± 3.414.25 ± 4.2

Adverse events

Collected over 2 years. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Treatment Group0/31 (0%)0/31 (0%)0/31 (0%)
Delayed Treatment Control Group0/23 (0%)0/23 (0%)0/23 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)Treatment GroupDelayed Treatment Control GroupTotal
Mean39 ± 10.6340.5 ± 8.7139.6 ± 9.74
Sex: Female, Male
Sex: Female, Male(Participants)Treatment GroupDelayed Treatment Control GroupTotal
Female181432
Male13922
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)Treatment GroupDelayed Treatment Control GroupTotal
Count of participants——0
Region of Enrollment
Region of Enrollment(participants)Treatment GroupDelayed Treatment Control GroupTotal
Israel211435
08

Study locations

1 site
  • Bar-Ilan University
    Ramat Gan, Israel
09

References and documents

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 documents

PDFs hosted by the registry, ClinicalTrials.gov.

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Mar 2018 to primary completion in Mar 2021, 36 months.

Results were first posted in Mar 2025, 4 years after primary completion.

Of 755 non-industry interventional studies with no phase under Schizophrenia, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 56. This study's 36 months is close to that.

Counting every sponsor, half of 768 studies reached it within 33 months; a quarter within 16 and three quarters within 56.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 4, 2018
First posted
Feb 9, 2018
StartActual
Mar 1, 2018
Primary completionActual
Mar 1, 2021
CompletionActual
Aug 1, 2021
Results first posted
Mar 6, 2025
Last update
Mar 6, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 6, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03427580
Lead sponsor
Bar-Ilan University, Israel
Responsible party
Ilanit Hasson-Ohayon (Prof. Ilanit Hasson-Ohayon, Principal Investigator, Bar-Ilan University, Israel) — Principal investigator
First posted
Feb 9, 2018
Start date
Mar 1, 2018
Primary completion
Mar 1, 2021
Completion
Aug 1, 2021
Results posted
Mar 6, 2025
Last update
Mar 6, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.

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