NCT03427580

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 4, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 9, 2018

Completed
20 days until next milestone

Study Start

First participant enrolled

March 1, 2018

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2021

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2021

Completed
3.6 years until next milestone

Results Posted

Study results publicly available

March 6, 2025

Completed
Last Updated

March 6, 2025

Status Verified

March 1, 2025

Enrollment Period

3 years

First QC Date

February 4, 2018

Results QC Date

May 7, 2022

Last Update Submit

March 2, 2025

Conditions

Keywords

SchizophreniaPsychotherapyMetacognitive abilitiesSession by session assessmentOutcome

Outcome Measures

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.

    Prior to the begining of the therapy (baseline, pre-treatment), and again at the end of the therapy (six months later, post-treatment)

Study Arms (2)

treatment group

EXPERIMENTAL
Behavioral: MERIT

delayed treatment control group

EXPERIMENTAL
Behavioral: MERIT

Interventions

MERITBEHAVIORAL

Metacognitive Reflection and Insight Therapy

delayed treatment control grouptreatment group

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bar-Ilan University

Ramat Gan, Israel

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Results Point of Contact

Title
Prof. Ilanit Hasson-Ohayon
Organization
Bar-Ilan University

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Ilanit Hasson-Ohayon, Principal Investigator

Study Record Dates

First Submitted

February 4, 2018

First Posted

February 9, 2018

Study Start

March 1, 2018

Primary Completion

March 1, 2021

Study Completion

August 1, 2021

Last Updated

March 6, 2025

Results First Posted

March 6, 2025

Record last verified: 2025-03

Locations