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

March 2, 2025 updated by: Ilanit Hasson-Ohayon, Bar-Ilan University, Israel

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

54

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Ramat Gan, Israel
        • Bar-Ilan University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • No co-morbid nuerological condition
  • No hospitalization in the last 6 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: treatment group
Behavioral: MERIT
Metacognitive Reflection and Insight Therapy
Experimental: delayed treatment control group
Behavioral: MERIT
Metacognitive Reflection and Insight Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Prior to the begining of the therapy (baseline, pre-treatment), and again at the end of the therapy (six months later, post-treatment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bar-Ilan University, Israel

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2018

Primary Completion (Actual)

March 1, 2021

Study Completion (Actual)

August 1, 2021

Study Registration Dates

First Submitted

February 4, 2018

First Submitted That Met QC Criteria

February 4, 2018

First Posted (Actual)

February 9, 2018

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 2, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MERIT

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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