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

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.

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

Is it effective and efficacious?

Study Overview

• Status: Completed
• Conditions: Schizophrenia
• Intervention / Treatment: Combination product: The combination of the Integrated Psychological Therapy and Metacognitive Training in individuals with schizophrenia and treatment resistant schizophrenia

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 Type: Interventional
• Enrollment (Actual): 35
• Phase: Phase 2

Contacts and Locations

Study Locations

• Greece
  • Athens, Greece, 15771
    • Stavroula Rakitzi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 60 years (Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Diagnosis of schizophrenia
• No relapse and hospitalization
• Ambulant psychiatric treatment

Exclusion Criteria:

• Other psychotic disorders
• Relapse and hospitalization
• Substance abuse

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

8

Arms and Interventions

Participant Group / 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. 2 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 C; Therapy Group C Intervention: Pharmacotherapy in combination with the Integrated Psychological Therapy and Metacognitive Training will be implemented. 8	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. 8	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. 3	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. 3	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 3	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. 3	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cognitive Functions: Matrics Consensus Cognitive Battery (MCCB), Greek Verbal Test	Greek verbal memory test: (verbal memory semantic condition (average) (minimum 0-maximum 40) (high scores better outcomes) MCCB: (Neuropsychological Assessment Battery) (NAB) (reasoning and problem solving): (minimum 0 maximum 26) (high scores better outcomes) Data is analyzed through SPS 13.	Baseline T1 (preintervention)-follow-up T3 (after 6 months, up to 55 weeks)
Symptoms, PANSS Greek Version	(PANSS) Greek Version Positive symptoms (minimum 8 maximum 49) low scores better outcomes Negative symptoms: (minimum 8 maximum 49) low scores better outcomes General Psychopathology: (minimum 17 maximum 112) low scores better outcomes Total: Sum of positive, negative and general symptoms (minimum 31, maximum 210), low scores better outcomes The total score is used in the statistical analysis (PSYRAT) Auditory hallucinations (minimum 0 maximum 44) low scores better Delusion (minimum 0 maximum 24) low scores better Data is analyzed with SPSS 13	Baseline T1 (preintervention)-follow-up T3 (after 6 months, up to 55 weeks)
Functional Outcome	WHO DAS 2.0 WHODAS total: (functional outcome) (minimum 0-maximum 100) low scores better outcomes Data are analyzed with SPSS 13	Baseline T1 (preintervention)-follow-up T3 (after 6 months, up to 55 weeks)
Recovery	RAS-DS scale Total score (sum of the scores) (0-152) high scores are better outcomes Data is analyzed through SPSS 13	Baseline T1 (preintervention)-follow-up T3 (after 6 months, up to 55 weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intelligent Quotient	Intelligence, high scores are better Data is analyzed through SPSS 13.	Baseline T1 (preintervention)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intelligent Quotient	WAIS: Aster Neubauer, Horn. 2006. Wechsler Intelligenz test fuer Erwachsense. Harcourt Test services	90 minutes

Collaborators and Investigators

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

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• Nuecterlein, K. H., & Green, M. F. (2006). MCCB. MATRICS Consensus Cognitive Battery. LA: MATRICS Assessment Inc.
• Fuentes, I., Garcia, S., Ruiz, J.C., Soler, J., & Roder, V. (2007). Social perception scale in Schizophrenia. A pilot study. International Journal of Psychology and Psychological therapy, 7 (1), 1-12.
• Kosmidou, M., & Vlahou, C. (2010). Greek verbal memory test. Athens: Parisianos.
• Lykouras, L., Botsis, A., & Oulis, P. (2005). Greek version of PANSS. Athens: Scientific publications.
• Haddock G, McCarron J, Tarrier N, Faragher EB. Scales to measure dimensions of hallucinations and delusions: the psychotic symptom rating scales (PSYRATS). Psychol Med. 1999 Jul;29(4):879-89. doi: 10.1017/s0033291799008661.
• Hancock, N., Scanlan, J.N., Bundy, A.C., & Honey A. (2019). Recovery Assessment Scale -Domains & Stages (RAS-DS) Manual- Version 3. Sydney: University of Sydney.
• Koumpouros, Y., Papageorgiou, E., Sakellari, E. et al. (2018). 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,18(1), 63-74. https://doi.org/10.1007/s10742-017-0176-x.
• Aster, M., Neubauer, M., & Horn, R. (2006). Wechsler-Intelligenztest für Erwachsene WIE. Frankfurt: Harcourt Test Services

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2022
• Primary Completion (Actual): March 26, 2024
• Study Completion (Actual): March 26, 2024

Study Registration Dates

• First Submitted: November 4, 2022
• First Submitted That Met QC Criteria: November 14, 2022
• First Posted (Actual): November 21, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 11, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Schizophrenia, treatment resistant schizophrenia, recovery
• Additional Relevant MeSH Terms: Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Schizophrenia, Treatment-Resistant; Schizophrenia
• Other Study ID Numbers: (2022-2024); (ATH22-24) (Other Identifier: Dr. Stavroula Rakitzi private practice)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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