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

Schizophrenia Clinical Trial

— 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.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05623228
• Other study ID #: (2022-2024)
• Secondary ID: (ATH22-24)
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: November 1, 2022
• Est. completion date: December 20, 2024

Study information

• Verified date: April 2024
• Source: Rakitzi, Stavroula
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Is it effective and efficacious?

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 35
• Est. completion date: December 20, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 60 Years

Eligibility

Inclusion Criteria:

• Diagnosis of schizophrenia

• No relapse and hospitalization

• Ambulant psychiatric treatment

Exclusion Criteria:

• Other psychotic disorders

• Relapse and hospitalization

• Substance abuse

Related Conditions & MeSH terms

• Schizophrenia

Intervention

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.

Locations

Country	Name	City	State
Greece	Stavroula Rakitzi	Athens

Sponsors (1)

Lead Sponsor	Collaborator
Rakitzi, Stavroula

Country where clinical trial is conducted

Greece, 

References & Publications (4)

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: — View 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 — View 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. — View 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/10.1027/101

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Intelligent Quotient	WAIS: Aster Neubauer, Horn. 2006. Wechsler Intelligenz test fuer Erwachsense. Harcourt Test services	90 minutes
Primary	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
Primary	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
Primary	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
Primary	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

External Links

•   linkedin Stavroula Rakitzi
•   orcid: 0000-0002-5231-6619