The Effectiveness and Efficacy of the Combination of the Integrated Psychological Therapy and Metacognitive Training.

Study Overview
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Brief Summary
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The combination of the Integrated Psychological Therapy and Metacognitive Training in individuals with schizophrenia and treatment resistant schizophrenia. Is it effective and efficacious?

Detailed Description
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Individuals with schizophrenia and treatment resistant schizophrenia will participate on a group cognitive behavioral therapy and rehabilitation, in which Integrated Psychological Therapy and Metacognitive Training are going to be implemented. The therapy will last 60 biweekly sessions. This is a non randomized trial. Speed of processing, working memory, verbal memory, visual memory, reasoning and problem solving, social cognition, symptoms, functional outcome and recovery will be evaluated before, after therapy and in a 6 months follow up. MCCB, Social Perception Scale, the Greek Test for verbal memory, PANSS, WHO DAS 2. 0 (Greek), PSYRAT and the Recovery Assessment Scale will be used ih this study.

Official Title
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The Effectiveness and Efficacy of the Combination of the Integrated Psychological Therapy and Metacognitive Training in Schizophrenia and Treatment Resistant Schizophrenia. This is a Non-randomized Trial. The Therapy Lasts 60 Sessions.

Conditions
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Schizophrenia

Intervention / Treatment
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* Combination Product: The combination of the Integrated Psychological Therapy and Metacognitive Training in individuals with schizophrenia and treatment resistant schizophrenia


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of schizophrenia No relapse and hospitalization Ambulant psychiatric treatment Exclusion Criteria: Other psychotic disorders Relapse and hospitalization Substance abuse

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 60 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: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: Pharmacotherapy in combination with the Integrated Psychological Therapy and Metacognitive Training will be implemented
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Therapy Group A<br>Therapy Group A Intervention: Pharmacotherapy in combination with the Integrated Psychological Therapy and Metacognitive Training will be implemented. 5 individuals with schizophrenia | Combination Product: The combination of the Integrated Psychological Therapy and Metacognitive Training in individuals with schizophrenia and treatment resistant schizophrenia<br>* The combination of pharmacotherapy and psychotherapy in individuals with schizophrenia and treatment resistant schizophrenia.<br>* Other names: Pharmacotherapy, rehabilitation;|
| Experimental: Therapy Group B<br>Therapy Group B Intervention: Pharmacotherapy in combination with the Integrated Psychological Therapy and Metacognitive Training will be implemented. 2 individuals with schizophrenia | Combination Product: The combination of the Integrated Psychological Therapy and Metacognitive Training in individuals with schizophrenia and treatment resistant schizophrenia<br>* The combination of pharmacotherapy and psychotherapy in individuals with schizophrenia and treatment resistant schizophrenia.<br>* Other names: Pharmacotherapy, rehabilitation;|
| Experimental: Therapy Group C<br>Therapy Group C Intervention: Pharmacotherapy in combination with the Integrated Psychological Therapy and Metacognitive Training will be implemented. | Combination Product: The combination of the Integrated Psychological Therapy and Metacognitive Training in individuals with schizophrenia and treatment resistant schizophrenia<br>* The combination of pharmacotherapy and psychotherapy in individuals with schizophrenia and treatment resistant schizophrenia.<br>* Other names: Pharmacotherapy, rehabilitation;|
| Experimental: Therapy Group D<br>Therapy Group D Intervention: Pharmacotherapy in combination with the Integrated Psychological Therapy and Metacognitive Training will be implemented. | Combination Product: The combination of the Integrated Psychological Therapy and Metacognitive Training in individuals with schizophrenia and treatment resistant schizophrenia<br>* The combination of pharmacotherapy and psychotherapy in individuals with schizophrenia and treatment resistant schizophrenia.<br>* Other names: Pharmacotherapy, rehabilitation;|
| Experimental: Therapy Group E<br>Therapy Group E Intervention: Pharmacotherapy in combination with the Integrated Psychological Therapy and Metacognitive Training will be implemented. | Combination Product: The combination of the Integrated Psychological Therapy and Metacognitive Training in individuals with schizophrenia and treatment resistant schizophrenia<br>* The combination of pharmacotherapy and psychotherapy in individuals with schizophrenia and treatment resistant schizophrenia.<br>* Other names: Pharmacotherapy, rehabilitation;|
| Experimental: Therapy Group F<br>Therapy Group F Intervention: Pharmacotherapy in combination with the Integrated Psychological Therapy and Metacognitive Training will be implemented. | Combination Product: The combination of the Integrated Psychological Therapy and Metacognitive Training in individuals with schizophrenia and treatment resistant schizophrenia<br>* The combination of pharmacotherapy and psychotherapy in individuals with schizophrenia and treatment resistant schizophrenia.<br>* Other names: Pharmacotherapy, rehabilitation;|
| Experimental: Therapy Group G<br>Therapy Group G Intervention: Pharmacotherapy in combination with the Integrated Psychological Therapy and Metacognitive Training will be implemented. | Combination Product: The combination of the Integrated Psychological Therapy and Metacognitive Training in individuals with schizophrenia and treatment resistant schizophrenia<br>* The combination of pharmacotherapy and psychotherapy in individuals with schizophrenia and treatment resistant schizophrenia.<br>* Other names: Pharmacotherapy, rehabilitation;|
| Experimental: Therapy Group H<br>Therapy Group H Intervention: Pharmacotherapy in combination with the Integrated Psychological Therapy and Metacognitive Training will be implemented. | Combination Product: The combination of the Integrated Psychological Therapy and Metacognitive Training in individuals with schizophrenia and treatment resistant schizophrenia<br>* The combination of pharmacotherapy and psychotherapy in individuals with schizophrenia and treatment resistant schizophrenia.<br>* Other names: Pharmacotherapy, rehabilitation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cognitive functions: Matrics Consensus Cognitive Battery (MCCB), SPS, Greek Verbal Test | Speed of processing Trail making Test Part A: BACS Symbol coding: Working memory: Letter number span, Greek Verbal memory: Visual learning: Brief Visuospatial Memory, Reasoning and problem solving: NAB Mazes, Social Cognition: Managing emotions (MSCEIT) (MCCB), Social Cognition: Social Perception Scale BACS Symbol coding: the number of the correct symbol coding in 90 seconds. (0-110). The increased score is associated with improvement Working memory: Letter number span: 0-24, the increased score is associated with improvement Rakitzi, S., 2007. The Letter Number Span in Greek. Translation. Unpublished. The LNS was translated in Greek fr | 45 minutes | 
| Symptoms | (PANSS): Lykouras, L., Botsis, A., & Ulis, P. (2005). PANSS. The Greek manual. Athens: Scientific publications. Positive symptoms 8-49, the decreased score is associated with improvement Negative symptoms: 8-49, the decreased score is associated with improvement General Psychopathology: 17-112, the decreased score is associated with improvement (PSYRAT): Haddock, G. , McCarron, J., Tarrier, N. and Faragher, E.B. (1999) Scales to measure dimensions of hallucinations and delusions: the psychotic symptom rating scales (PSYRATS). Psychological Medicine, 29, 879-889 Dr. Stavroula Rakitzi has the permission to use this scale Each category has a score 1-4, the decreased score is associated with improvement. To generate a total score for the rating scale overall, calculate the total of all auditory hallucination items. To generate a total score for the rating scale overall, calculate the total of all delusions items. | 40 minutes | 
| Functional outcome | WHO DAS 2.0: Koumpouros, I., Sakellari, E., Papageorgiou, E., & Lagiou, A. (2017). WHODAS 2. 0. Greek Manual Koumpouros, I., Papageorgiou, E., Sakellari, E. et al. Adaptation and psychometric properties evaluation of the Greek version of WHODAS 2.0. pilot application in Greek elderly population. Health Services and Outcomes Research Methodology, 2018, 18(1): 63-74. https://doi.org/10.1007/s10742-017-0176-x Calculation 0-100 The decreased score is associated with better functional outcome | 20 minutes | 
| Recovery | Recovery Assessment Scale: Hancock, N., Scanlan, J.N., Bundy, A.C., & Honey, A. (2016). Recovery Assessment Scale - Domains & Stages (RAS-DS) Manual- Version 2. Sydney; University of Sydney. The scale is translated in Greek from Dr. Stavroula Rakitzi in cooperation with Prof. Hancock. The increased score is associated with improvement Total score 0-152 | 10 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Schizophrenia, treatment resistant schizophrenia, recovery