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.
Phase: PHASE2
Conditions: Schizophrenia
Sponsor: Rakitzi, Stavroula

Athens Greece 15. 11. 2024 
ClinicalTrials.gov ID: NCT05623228 
 
Brief Title: The Effectiveness and Efficacy of the Combination of the Integrated 
Psychological Therapy and Metacognitive Training. ( ATHSCHIZ ) (ATH22-24) 
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. 
Dr. Stavroula Rakitzi 
Clinical psychologist and cognitive behavioral psychotherapist 
Private practice 
ILISION 34 
15771 Athens Greece 
Tel: +306989766935 
srakitzi@gmail.com 
Links: URL: https://www.linkedin.com/ 
Description linkedin Stavroula Rakitzi 
URL: http://orcid.org 
Description orcid: 0000-0002-5231-6619 
 
 
 
 
 
 
 
 
 
 
Dr. Polyxeni Georgila 

Psychiatrist and cognitive behavioral psychotherapist 
Private practice 
ILISION 34 
15771 Athens Greece 
Tel: +306932905259 
polyxenigeorgila@gmail.com 
Links: URL: https://www.linkedin.com/ 
Description linkedin Polyxeni Georgila 
URL: http://orcid.org 
Orcid:0000-0003-3137-506X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Abstract 

The aim of this study was to evaluate the effectiveness of the combination of Integrated 
psychological Therapy and the metacognitive training for psychosis. All the subprograms 
of IPT in 50 sessions and 10 sessions of MCT were offered in two biweekly one-hour 
sessions. 35 patients with schizophrenia took part in this study. Cognition, symptoms, 
functional outcome and recovery were assessed with a test battery before the therapy, 
after the therapy and in a follow-up after 6 months. General linear model and regression 
analysis were used. Significant effects were found in neurocognition, symptoms, 
functional outcomes and recovery. Effect sizes were also calculated. Significant effects 
were also found for the subgroup with treatment resistant schizophrenia in 
neurocognition, social cognition, symptoms, functional outcome and recovery. Effect 
sizes were also calculated. This study supports evidence for the effectiveness of the 
combination of IPT and MCT in Greece. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1. Introduction 
Schizophrenia presents a chronic mental health disorder with a high vulnerability and a 
huge emotional and social burden. Schizophrenia and especially treatment resistant 

schizophrenia (TRS) needs evidence-based and recovery-oriented pharmacotherapy 
and cognitive behavioral psychotherapy and rehabilitation. Pharmacotherapy presents 
the main therapy for patients with schizophrenia (Huhn et al., 2019; Leucht et al., 2013; 
Taipale et al., 2018; Wagner et al., 2021).The Integrated Psychological Therapy (IPT) 
presents an efficacious evidencebased rehabilitation program for patients with 
schizophrenia (Roder et al., 2008, 2010, 2011, 2013). It is also translated in Greek 
(Roder, 2007). Our research group has implemented Integrated Psychological Therapy 
(IPT) the last years in Greece (Rakitzi et al., 2016, 2019, 2020, 2021). There are also 
other research groups in Greece that implemented IPT (Poulou, 2024). In other words, 
IPT is well known and established in Greece.  
Metacognitive Training (MCT) for Psychosis presents also an efficacious and evidence-
based therapy for people with schizophrenia and other psychotic disorders (Moritz et al., 
2022; Penney et al., 2022; Veckenstedt & Scheunemann, 2023). MCT is implemented 
nowadays also in other mental health disorders, such as bipolar disorder and 
depression.MCT for psychosis is implemented for the first time in Greece in this research  
project. This is also the first study, as far as it is known, in which IPT will be combined 
with MCT.IPT and MCT present two therapy programs which are used in our private 
practice systematically.The main hypothesis is: The combination of IPT and MCT is 
effective and  
efficacious. The therapy shows improvement in cognition (neurocognition, social 
cognition), in psychopathology, in functional outcome and recovery. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1. Material and methods 
 
2.1. Compliance with ethical standards 

The patients have given written informed consent for their participation in this research 
project prior to the inclusion of the study. Details which might disclose the identity of 
the patients were omitted. The authors follow the APA ethical standards. 
The authorities in Greece does not prohibit the conducting of research protocols from 
scientists who treat patients in a private practice. There is no ethical commission which 
evaluates research projects from scientists in the private sector. 
2.2. Study population 
The outpatients with schizophrenia were recruited from Dr. P. Georgila psychiatrist 
and cognitive behavioral psychotherapist and Dr. S. Rakitzi clinical psychologist and 
cognitive behavioral psychotherapist from their own private practice. All participants 
were treated by both authors ambulant the last 15 years. All participants are treated 
monthly by Dr. P. Georgila and participated in individual cognitive behavioral 
psychotherapy of 30 sessions in the past by Dr. S. Rakitzi. 
A motivational interview was conducted with all the patients from Dr. Georgila and Dr. 
Rakitzi to enhance their motivation for participating in a group cognitive behavioral 
psychotherapy and rehabilitation. The patients have given written informed consent 
for their participation in this research project, and they were not paid for their 
participation. A total of 35 patients with schizophrenia participated in this study. 
The inclusion and exclusion criteria of the study were the following: inclusion criteria: 
patients with schizophrenia between 19-60 years old, an IQ over 80 and patients must 
be treated in an ambulant psychiatric treatment. Exclusion criteria: Relapse and 
hospitalization, substance abuse and diagnosis of other psychotic disorders. 
Finally, pharmacotherapy was not changed from Dr. P. Georgila during the therapy, 
after the therapy and in the follow-up evaluation. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
2.3. Study design 
 
 
It is a non-randomized study. Patients were evaluated in a baseline assessment (T1) 

and were allocated to the therapy group. Afterwards, they were evaluated in post 
therapy after 60 sessions (T2) and at a follow up of 6 months after the end of the 
therapy (T3). 
2.4. Therapists 
Dr, P. Georgila and Dr. S. Rakitzi were the therapists. Dr. Georgila was the main 
therapist for the subprograms of IPT cognitive differentiation, social perception and 
verbal communication and Dr. S. Rakitzi the co-therapist. Dr. S. Rakitzi was the main 
therapist for the subprograms of IPT social skills and problem-solving and for the MCT 
for psychosis. Dr. P. Georgila was co-therapist. Both therapists are well trained by IPT 
and MCT. 
2.5. Intervention 
IPT is a group therapy for patients with schizophrenia and contains 5 subprograms: 
Cognitive differentiation (neurocognition), social perception (social cognition), verbal 
communication, social skills and interpersonal problem-solving and presents an 
efficacious and evidence-based program for patients with schizophrenia (Roder et al., 
2008, 2010). IPT was translated in Greek and was implemented with success from our 
research group (Rakitzi et al., 2016, 2019, 2020, Roder et al., 2007. IPT was 
implemented also from other research groups in Greece with very good results (Poulou 
et al., 2024). In other words, IPT is well known and established in Greece. 
All 5 subprograms of IPT in 50 biweekly sessions of 1 hour were implemented in this 
study. 
MCT presents an efficacious and evidence-based group rehabilitation program for 
many mental health disorders. 10 biweekly sessions of one hour of MCT for psychosis 
were implemented in this study after IPT. It is the first implementation of MCT in 
Greece. 
The implementation of this therapy was conducted in 8 small groups: 1 (5 patients), 
2(2 patients), 3(8 patients), 4(8 patients), 5(3 patients), 6(3 patients), 7(3 patients), 8(3 
patients). 
 
 
 
 
 
 
 
 
2.6. Measures 
2. 6. 1 WAIS 
WAIS was implemented to all patients from Dr. S. Rakitzi for the evaluation of IQ before 

the baseline assessment of this research project (Aster. 2006). 
2. 6. 2. Cognition (proximal outcome) 
Neurocognition (speed of processing, working memory, visual memory, reasoning and 
problem-solving) of MCCB were used. Working memory was evaluated with the Letter 
Number Span using the Greek translation (Gold et al., 1997; Nuechterlein & Green, 
2006, Rakitzi, 2007a). The Greek verbal memory test was used to evaluate verbal 
memory-oral and written (Kosmidou, 2010). Social cognition (MSCEIT-emotional 
intelligence) of MCCB (Nuechterlein & Green, 2006) and social perception scale using 
the Greek translation were also used (Garcia et al., 2003; Rakitzi et al., 2007b; Ruiz 
et al., 2005). A blinded rater (Msc. Clinical psychology) has given the above tests 
before the therapy, after the therapy and in the follow-up of 6 months. 
2.6.3. Psychopathology (proximal outcome) 
Psychopathology was evaluated from PRYRAT (Haddock et al., 1999) and PANSS 
(Lykouras et al., 2005). A blinded rater (M. D.) has conducted the PSYRAT and 
PANSS before the therapy, after the therapy and in the follow-up after 6 months. 
2.6.4. Functional outcome (proximal outcome) 
Functional outcome was from WHODAS evaluated (Koumpouros et al., 2018; WHO, 
2001). A blinded rater (Msc. Clinical psychology) has given the above tests before the 
therapy, after the therapy and in the follow-up of 6 months. 
2.6.5. Recovery (proximal outcome) 
Recovery was evaluated from the Greek version of RAS-DS (Hancock et al., 2019, 
2023). RAS-DS is a reliable and valid scale (Hancock et al., 2015, 2019; Honey et al., 
2023; Ramesh et al., 2024). A blinded rater (Msc. Clinical psychology) has given the 
above tests before the therapy, after the therapy and in the follow-up of 6 months. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
2. 7. Statistical analysis 
 
SPSS version 13 has been used for statistical analysis. A general linear model for 
repeated measures was chosen. A general linear model understands and quantifies the 
relationship between therapy and the proximal outcomes. A Bonferroni correction was 
made. Confounding variables were controlled. A regression analysis was conducted. A 

regression analysis quantifies the strength between the variables (therapy and proximal 
outcomes) Effect sizes were also calculated. A statistical analysis (general linear model, 
effect sizes, regression analysis) was conducted for the 35 participants and afterward a 
second analysis was conducted (general linear model, effect sizes, regression analysis) 
focusing on the group of treatment resistant schizophrenia (Bortz & Döring, 2002; 
Cohen, 1988). 
 
 

 
 
 

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