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

Study Overview
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Brief Summary
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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. **Till now (July 2019) 34 clients have been recruited: 7 clients completed the MERIT therapy; 12 clients are receiving MERIT therapy now days; 6 clients are on the waiting list; 9 dropouts.

Official Title
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Metacognitive and Insight Therapy (MERIT) for Persons With Schizophrenia: Assessment of Session by Session Progress and Outcome.

Conditions
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Diagnosis of Schizophrenia Spectrum Disorders

Intervention / Treatment
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* Behavioral: MERIT


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: treatment group<br> | Behavioral: MERIT<br>* Metacognitive Reflection and Insight Therapy<br>|
| Experimental: delayed treatment control group<br> | Behavioral: MERIT<br>* Metacognitive Reflection and Insight Therapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Indiana Psychiatric Illness Interview | Interview | 45 minutes | 
| Positive and Negative Syndrome Scale | Clinician-rated scale | 15 minutes | 
| Social Skill Performance Assessment | Verbal role-play assessment | 15 minutes | 
| Face Emotion Identification Task | Questionnaire | 5 minutes | 
| Faux-Pas task | questionnaire | 10 minutes | 
| Ambiguous Intentions Hostility Questionnaire | Questionnaire | 5 minutes | 
| Heinrichs-Carpenter Quality of Life scale | Clinician-rated scale | 30 minutes | 
| Beck Depression Inventory-II | Questionnaire | 5 minutes | 
| Outcome Questionnaire -45 | Questionnaire | 5 minutes | 
| The Life Regard Index | Questionnaire | 5 minutes | 
| The Internalized Stigma of Mental Illness scale | Questionnaire | 5 minutes | 
| Self-compassion Scale | Questionnaire | 5 minutes | 
| The Self-Concept Clarity scale | Questionnaire | 5 minutes | 
| Difficulties in Emotion Regulation Scale | Questionnaire | 5 minutes | 
| The Emotion Regulation Questionnaire | Questionnaire | 5 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Session by session assessment, Schizophrenia, Psychotherapy, Metacognitive abilities, Outcome