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

Primary Purpose

Schizophrenia

Status
Recruiting
Phase
Phase 2
Locations
Greece
Study Type
Interventional
Intervention
The combination of the Integrated Psychological Therapy and Metacognitive Training in individuals with schizophrenia and treatment resistant schizophrenia
Sponsored by
Rakitzi, Stavroula
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia, treatment resistant schizophrenia, recovery

Eligibility Criteria

19 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Stavroula RakitziRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Therapy Group A

Therapy Group B

Therapy Group C

Therapy Group D

Therapy Group E

Therapy Group F

Therapy Group G

Therapy Group H

Arm Description

Therapy Group A Intervention: Pharmacotherapy in combination with the Integrated Psychological Therapy and Metacognitive Training will be implemented. 5 individuals with schizophrenia

Therapy Group B Intervention: Pharmacotherapy in combination with the Integrated Psychological Therapy and Metacognitive Training will be implemented. 2 individuals with schizophrenia

Therapy Group C Intervention: Pharmacotherapy in combination with the Integrated Psychological Therapy and Metacognitive Training will be implemented.

Therapy Group D Intervention: Pharmacotherapy in combination with the Integrated Psychological Therapy and Metacognitive Training will be implemented.

Therapy Group E Intervention: Pharmacotherapy in combination with the Integrated Psychological Therapy and Metacognitive Training will be implemented.

Therapy Group F Intervention: Pharmacotherapy in combination with the Integrated Psychological Therapy and Metacognitive Training will be implemented.

Therapy Group G Intervention: Pharmacotherapy in combination with the Integrated Psychological Therapy and Metacognitive Training will be implemented.

Therapy Group H Intervention: Pharmacotherapy in combination with the Integrated Psychological Therapy and Metacognitive Training will be implemented.

Outcomes

Primary Outcome Measures

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
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.
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
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

Secondary Outcome Measures

Full Information

First Posted
November 4, 2022
Last Updated
March 10, 2023
Sponsor
Rakitzi, Stavroula
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1. Study Identification

Unique Protocol Identification Number
NCT05623228
Brief Title
The Effectiveness and Efficacy of the Combination of the Integrated Psychological Therapy and Metacognitive Training.
Acronym
ATHSCHIZ
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.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2022 (Actual)
Primary Completion Date
July 31, 2024 (Anticipated)
Study Completion Date
December 20, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rakitzi, Stavroula

4. Oversight

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
Data Monitoring Committee
No

5. 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?
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Schizophrenia, treatment resistant schizophrenia, recovery

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Model Description
Pharmacotherapy in combination with the Integrated Psychological Therapy and Metacognitive Training will be implemented
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Therapy Group A
Arm Type
Experimental
Arm Description
Therapy Group A Intervention: Pharmacotherapy in combination with the Integrated Psychological Therapy and Metacognitive Training will be implemented. 5 individuals with schizophrenia
Arm Title
Therapy Group B
Arm Type
Experimental
Arm Description
Therapy Group B Intervention: Pharmacotherapy in combination with the Integrated Psychological Therapy and Metacognitive Training will be implemented. 2 individuals with schizophrenia
Arm Title
Therapy Group C
Arm Type
Experimental
Arm Description
Therapy Group C Intervention: Pharmacotherapy in combination with the Integrated Psychological Therapy and Metacognitive Training will be implemented.
Arm Title
Therapy Group D
Arm Type
Experimental
Arm Description
Therapy Group D Intervention: Pharmacotherapy in combination with the Integrated Psychological Therapy and Metacognitive Training will be implemented.
Arm Title
Therapy Group E
Arm Type
Experimental
Arm Description
Therapy Group E Intervention: Pharmacotherapy in combination with the Integrated Psychological Therapy and Metacognitive Training will be implemented.
Arm Title
Therapy Group F
Arm Type
Experimental
Arm Description
Therapy Group F Intervention: Pharmacotherapy in combination with the Integrated Psychological Therapy and Metacognitive Training will be implemented.
Arm Title
Therapy Group G
Arm Type
Experimental
Arm Description
Therapy Group G Intervention: Pharmacotherapy in combination with the Integrated Psychological Therapy and Metacognitive Training will be implemented.
Arm Title
Therapy Group H
Arm Type
Experimental
Arm Description
Therapy Group H Intervention: Pharmacotherapy in combination with the Integrated Psychological Therapy and Metacognitive Training will be implemented.
Intervention Type
Combination Product
Intervention Name(s)
The combination of the Integrated Psychological Therapy and Metacognitive Training in individuals with schizophrenia and treatment resistant schizophrenia
Other Intervention Name(s)
Pharmacotherapy, rehabilitation
Intervention Description
The combination of pharmacotherapy and psychotherapy in individuals with schizophrenia and treatment resistant schizophrenia.
Primary Outcome Measure Information:
Title
Cognitive functions: Matrics Consensus Cognitive Battery (MCCB), SPS, Greek Verbal Test
Description
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
Time Frame
45 minutes
Title
Symptoms
Description
(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.
Time Frame
40 minutes
Title
Functional outcome
Description
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
Time Frame
20 minutes
Title
Recovery
Description
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
Time Frame
10 minutes
Other Pre-specified Outcome Measures:
Title
Intelligent Quotient
Description
WAIS: Aster Neubauer, Horn. 2006. Wechsler Intelligenz test fuer Erwachsense. Harcourt Test services
Time Frame
90 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of schizophrenia No relapse and hospitalization Ambulant psychiatric treatment Exclusion Criteria: Other psychotic disorders Relapse and hospitalization Substance abuse
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stavroula Rakitzi, Dr
Phone
+302111180571
Email
srakitzi@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Polyxeni Georgila, M. D.
Phone
+306932905259
Email
polyxenigeorgila@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stavroula Rakitzi, Dr.
Organizational Affiliation
Private Practice
Official's Role
Study Director
Facility Information:
Facility Name
Stavroula Rakitzi
City
Athens
ZIP/Postal Code
15771
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stavroula Rakitzi, Dr.
Phone
+2111180571
Email
srakitzi@gmail.com
First Name & Middle Initial & Last Name & Degree
Polyxeni Georgila, M. D.
Phone
+6932905259
Email
polyxenigeorgila@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31385737
Citation
Rakitzi S, Georgila P. Integrated Psychological Therapy and Treatment-Resistant Schizophrenia: Initial Findings. Psychiatry. 2019 Winter;82(4):354-367. doi: 10.1080/00332747.2019.1616658. Epub 2019 Aug 6.
Results Reference
background
PubMed Identifier
35320347
Citation
Penney D, Sauve G, Mendelson D, Thibaudeau E, Moritz S, Lepage M. Immediate and Sustained Outcomes and Moderators Associated With Metacognitive Training for Psychosis: A Systematic Review and Meta-analysis. JAMA Psychiatry. 2022 May 1;79(5):417-429. doi: 10.1001/jamapsychiatry.2022.0277.
Results Reference
result
PubMed Identifier
27280523
Citation
Rakitzi S, Georgila P, Efthimiou K, Mueller DR. Efficacy and feasibility of the Integrated Psychological Therapy for outpatients with schizophrenia in Greece: Final results of a RCT. Psychiatry Res. 2016 Aug 30;242:137-143. doi: 10.1016/j.psychres.2016.05.039. Epub 2016 May 30.
Results Reference
result
Citation
Rakitzi, S., Georgila, P., Becker-Woitag, A.P. (2021). The recovery process for individuals with schizophrenia in the context of evidence based psychotherapy and rehabilitation. A systematic review. European Psychologist, 26(2), 96-111 doi/pdf/10.1027/1016-9040/a000400.
Results Reference
result
Links:
URL
https://www.linkedin.com/
Description
linkedin Stavroula Rakitzi
URL
http://orcid.org
Description
orcid: 0000-0002-5231-6619

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

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