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

Sponsor
Rakitzi, Stavroula (Other)
Overall Status
Recruiting
CT.gov ID
NCT05623228
Collaborator
(none)
50
Enrollment
1
Location
8
Arms
25.6
Anticipated Duration (Months)
2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The combination of the Integrated Psychological Therapy and Metacognitive Training in individuals with schizophrenia and treatment resistant schizophrenia.

Is it effective and efficacious?

Condition or Disease Intervention/Treatment Phase
  • Combination Product: The combination of the Integrated Psychological Therapy and Metacognitive Training in individuals with schizophrenia and treatment resistant schizophrenia
 Phase 2

Detailed Description

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Intervention Model Description:
Pharmacotherapy in combination with the Integrated Psychological Therapy and Metacognitive Training will be implementedPharmacotherapy in combination with the Integrated Psychological Therapy and Metacognitive Training will be implemented
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
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.
Actual Study Start Date :
Nov 1, 2022
Anticipated Primary Completion Date :
Jul 31, 2024
Anticipated Study Completion Date :
Dec 20, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Therapy Group A

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
The combination of pharmacotherapy and psychotherapy in individuals with schizophrenia and treatment resistant schizophrenia.
Other Names:
  • Pharmacotherapy, rehabilitation

    		•
    Experimental: Therapy Group B

    Therapy Group B 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
    The combination of pharmacotherapy and psychotherapy in individuals with schizophrenia and treatment resistant schizophrenia.
    Other Names:
  • Pharmacotherapy, rehabilitation

    		•
    Experimental: Therapy Group C

    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
    The combination of pharmacotherapy and psychotherapy in individuals with schizophrenia and treatment resistant schizophrenia.
    Other Names:
  • Pharmacotherapy, rehabilitation

    		•
    Experimental: Therapy Group D

    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
    The combination of pharmacotherapy and psychotherapy in individuals with schizophrenia and treatment resistant schizophrenia.
    Other Names:
  • Pharmacotherapy, rehabilitation

    		•
    Experimental: Therapy Group E

    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
    The combination of pharmacotherapy and psychotherapy in individuals with schizophrenia and treatment resistant schizophrenia.
    Other Names:
  • Pharmacotherapy, rehabilitation

    		•
    Experimental: Therapy Group F

    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
    The combination of pharmacotherapy and psychotherapy in individuals with schizophrenia and treatment resistant schizophrenia.
    Other Names:
  • Pharmacotherapy, rehabilitation

    		•
    Experimental: Therapy Group G

    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
    The combination of pharmacotherapy and psychotherapy in individuals with schizophrenia and treatment resistant schizophrenia.
    Other Names:
  • Pharmacotherapy, rehabilitation

    		•
    Experimental: Therapy Group H

    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
    The combination of pharmacotherapy and psychotherapy in individuals with schizophrenia and treatment resistant schizophrenia.
    Other Names:
  • Pharmacotherapy, rehabilitation

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Cognitive functions: Matrics Consensus Cognitive Battery (MCCB), SPS, Greek Verbal Test [45 minutes]

      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

    2. Symptoms [40 minutes]

      (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.

    3. Functional outcome [20 minutes]

      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

    4. Recovery [10 minutes]

      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

    Other Outcome Measures

    1. Intelligent Quotient [90 minutes]

      WAIS: Aster Neubauer, Horn. 2006. Wechsler Intelligenz test fuer Erwachsense. Harcourt Test services

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Diagnosis of schizophrenia

    • No relapse and hospitalization

    • Ambulant psychiatric treatment

    Exclusion Criteria:

    • Other psychotic disorders

    • Relapse and hospitalization

    • Substance abuse

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Stavroula Rakitzi Athens Greece 15771

    Sponsors and Collaborators

    • Rakitzi, Stavroula

    Investigators

    • Study Director: Stavroula Rakitzi, Dr., Private Practice

    Study Documents (Full-Text)

    More Information

    Additional Information:

    Publications

    Responsible Party:
    Rakitzi, Stavroula
    ClinicalTrials.gov Identifier:
    NCT05623228
    Other Study ID Numbers:
    • (2022-2024)
    • (ATH22-24)
    First Posted:
    Nov 21, 2022
    Last Update Posted:
    Dec 20, 2022
    Last Verified:
    Nov 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    Yes
    Keywords provided by Rakitzi, Stavroula
    Schizophrenia, treatment resistant schizophrenia, recovery
    Additional relevant MeSH terms:
    Schizophrenia

    Study Results

    No Results Posted as of Dec 20, 2022