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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| treatment group | Experimental |
| |
| delayed treatment control group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MERIT | Behavioral | Metacognitive Reflection and Insight Therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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:
| Prior to the begining of the therapy (baseline, pre-treatment), and again at the end of the therapy (six months later, post-treatment) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bar-Ilan University | Ramat Gan | Israel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32271073 | Derived | 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. |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment Group | MERIT: Metacognitive Reflection and Insight Therapy |
| FG001 | Delayed Treatment Control Group | MERIT: Metacognitive Reflection and Insight Therapy |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment Group | MERIT: Metacognitive Reflection and Insight Therapy |
| BG001 | Delayed Treatment Control Group | MERIT: Metacognitive Reflection and Insight Therapy |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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:
| The N in the "POST" row is following dropouts. Treatment Group Arm: Baseline/pre-treatment and post-treatment at 24 weeks; For Delayed Treatment Control Group Arm: Baseline/pre-waiting period and 6 months post-waiting period prior to starting treatment. | Posted | Mean | Standard Deviation | score on a scale | Prior to the begining of the therapy (baseline, pre-treatment), and again at the end of the therapy (six months later, post-treatment) |
2 years
The definition of adverse event and/or serious adverse event does not differ from the clinicaltrials.gov Definitions.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment Group | MERIT: Metacognitive Reflection and Insight Therapy | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof. Ilanit Hasson-Ohayon | Bar-Ilan University | +972-3-5317673 | ilanithasson@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 1, 2023 | Feb 8, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | The number analyzed in row differs from overall due to dropouts. | Number | participants |
|
| ID | Title | Description |
|---|---|---|
| OG000 | Delayed Treatment Control Group | MERIT: Metacognitive Reflection and Insight Therapy |
| OG001 | Treatment Group | MERIT: Metacognitive Reflection and Insight Therapy |
|
|
| 31 |
| 0 |
| 31 |
| 0 |
| 31 |
| EG001 | Delayed Treatment Control Group | MERIT: Metacognitive Reflection and Insight Therapy | 0 | 23 | 0 | 23 | 0 | 23 |
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