The Effectiveness and Efficacy of the Combination of Pharmacotherapy With the Two New Recovery-oriented Programs, RECOVERYTRSGR (Treatment Resistant Schizophrenia) and RECOVERYTRSBDGR (Treatment Resistant Bipolar Disorder)
Phase: PHASE4
Conditions: Treatment Resistant Schizophrenia, Treatment Resistant Bipolar Disorder
Sponsor: Dr. Stavroula Rakitzi

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                                                                       Athens, 1.06. 2025 
  
The effectiveness and efficacy of the combination of pharmacotherapy with the 
two new recovery-oriented programs, RECOVERYTRSGR for patients with 
treatment- resistant schizophrenia and RECOVERYTRSBDGR for patients with 
treatment- resistant bipolar disorder. 
  
  
Dr. phil., Dipl.-Psych., Stavroula Rakitzi 
  
Clinical psychologist and cognitive behavioral psychotherapist 
Private practice 
ILISION 34 15771 Athens Greece 
  
2111180571 
  
6989766935 
  
Stavroula@Rakitzi.onmicrosoft.com 
Description linkedin Stavroula Rakitzi 
ORCID: http://0000-0002-5231-6619 
Polyxeni Georgila, M. D. Psychiatrist and cognitive behavioral psychotherapist 
Private practice 
ILISION 34 15771 Athens Greece 
  
6932905259 
  
polyxenigeorgila@gmail.com 
  
Description linkedin Polyxeni Georgila 
ORCID: http://0000-0003-3137-506X 
 
  

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Chronic mental health disorders present a huge burden for the patients and their 
families. Long-term pharmacotherapy and long-term recovery-oriented psychotherapy 
are important treatments to cope with this burden. 
Schizophrenia and bipolar disorders present the most difficult chronic mental health 
disorders. Both are associated with high suicidal risk, cognitive impairment, many 
dropouts, bad adherence to treatments, and many hospitalizations. Treatment 
resistant schizophrenia and treatment resistant bipolar disorder are two subcategories 
of these mental health disorders, which are linked to higher suicidal risk, exacerbated 
cognitive impairment and numerous hospitalizations. 
Treatment-resistant means that patients do not respond favorably to most of the 
medications, and certain combinations of agents work well for these patient groups. 
The sooner schizophrenia and bipolar disorder are diagnosed as treatment-resistant, 
the better for the patient, the psychiatrist and the cognitive behavioral psychotherapist. 
RECOVERYTRSGR (Rakitzi & Georgila, 2024) and RECOVERYTRSBDGR (Rakitzi 
& Georgila, 2024b) are two newly developed recovery-oriented programs for patients 
with treatment-resistant schizophrenia and patients with treatment-resistant bipolar 
disorder, which were developed by us. These programs are the consequence of our 
clinical experience with treatment-resistant patients with schizophrenia and bipolar 
disorder and the difficulties of the Greek Health System (private and public sector) 
with these two disorders. These recovery-oriented programs aim to help patients to 
reintegrate into society from the recovery perspective, to gain more awareness 
towards the disorder, to be more responsible towards their problems, and to be more 
assertive towards their own human rights. 
  
  
  
  
  
  
  
  

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RECOVERYTRSGR for patients with treatment-resistant schizophrenia contains 190 
therapeutic sessions. The introductory phase contains 20 sessions. The second 
phase 
  
contains 160 sessions with individual and group cognitive behavioral psychotherapy 
and rehabilitation. The third phase contains 8 sessions (an epilogue), and finally, two 
monthly follow-ups provided at the end. 
Selection criteria: Inclusion criteria: age 18-65, IQ ≥ 80, diagnosis TRS. Exclusion 
criteria: Substance abuse and head injury. If substance abuse is successfully treated, 
the participant will be accepted into our program. 
Reliable and valid tests are going to be administered before the therapy, after the 
therapy and in a follow-up after 6 months after therapy. 
Aster et al. (2006) should be used before treatment to show the burden of cognitive 
dysfunction and intellectual ability, and it is repeatable after one year. An intelligence 
quotient (IQ) ≥ 80 is a necessary condition to participate in our recovery model for 
TRS. 
The Matrics Consensus Cognitive Battery (MCCB) (Nuechterlein & Green, 2006) for 
cognitive functions, the Greek verbal memory test for the evaluation of the verbal 
memory (Kosmidou & Vlahou, 2010), the Positive and Negative Syndrome Scale 
(PANSS) (Kay et al., 1987; Lykouras et al., 2005), WHODAS 2 0 (Koumpouros et al., 
2018; WHO, 2001) for disability and functional capacity, the Recovery Assessment 
Scale-Domains and Stages (RAS-DS) (Hancock et al., 2019, 2023) for the evaluation 
of the recovery process and clinical global impression scale (CGI) for the evaluation 
of the global functioning (Busner & Targum, 2007; Guy, 1976) are going to be 
administered before the therapy, after the therapy and in a follow-up after 6 months. 
 
 
RECOVERYTRSBDGR contains 140 sessions. The introductory phase contains 20 
sessions. The second phase contains 108 sessions with individual and group 

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cognitive behavioral psychotherapy and rehabilitation. The third phase contains 8 
sessions (an epilogue), and finally, four monthly follow-ups provided at the end. 
  
An intelligence quotient (IQ) ≥ 80 is a necessary condition to participate in our recovery 
model for TRSBD. Selection criteria: inclusion criteria: age 18-65, IQ ≥ 80, diagnosis 
  
TRSBD. Exclusion criteria: Substance abuse and head injuries. If substance abuse is 
successfully treated, the participant will be acknowledged into our program. 
WAIS (Aster et al., 2006) should be used before treatment to show the burden of 
cognitive dysfunction and intellectual ability, and it is repeatable after one year. The 
symptom checklist 90-R (Donias et al., 1991), the Altman self-rating Mania Scale 
(Altman et al., 1997) (Greek Version), the Young Mania Rating Scale (Young et al., 
1978), the Symptoms Rating Scale for Depression and Anxiety (SRSDSA) (Bech, 
1993; Fountoulakis, 2003), the Hamilton Depression Scale (HAM-D) (Hamilton, 1960) 
(the Greek version), the Montgomery and Asperg Depression Rating Scale (MADRS) 
(Montgomery & Asperg, 1979; Williams & Kobak, 2008) (the Greek version) and the 
psychotic symptom rating scales (PSYRATS) (Haddock, 1999) can also be used. 
WHODAS 2. 0 (Koumpouros et al., 2018; WHO, 2001) for disability and functional 
capacity, the Recovery Assessment Scale-Domains and Stages (RAS-DS) for the 
evaluation of the recovery process (Hancock et al., 2019, 2023) and clinical global 
impression scale (CGI) for the evaluation of the global functioning (Busner & Targum, 
2007; Guy, 1976) offer valid and reliable tests. All the above-mentioned tests are going 
to be administered before the therapy, after the therapy and in a follow-up after 6 
months. 
Our research project aims to evaluate the efficacy and effectiveness of the 
combination of pharmacotherapy with these two programs. The project will begin in 
May 2025 and finish in December 2027. 
  
  
RECOVERYTRSGR will be compared to treatment as usual (TAU) and 
RECOVERYTRSBDGR will be compared also to TAU. TAU means that patients with 
treatment-resistant schizophrenia will participate in 190 sessions-2 times monthly 
  

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psychiatric treatment and individual psychotherapy (psychoeducation, cognitive 
behavioral psychotherapy and psychoeducation to family, social skills training). TAU 
by treatment resistant bipolar disorder, means that patients will participate in 140 
session-2 times monthly psychiatric treatment and individual psychotherapy 
(psychoeducation, cognitive behavioral psychotherapy, psychoeducation to family, 
social skills training). 
Tests will be given before the therapy, after the therapy and in a follow-up after 6 
months. 
Study population 
  
The outpatients with treatment resistant schizophrenia and treatment resistant bipolar 
disorder will be recruited by Dr. Stavroula Rakitzi, clinical psychologist and cognitive 
behavioral psychotherapist and Dr. Polyxeni Georgila, psychiatrist and cognitive 
behavioral psychotherapist from their own private practice. 
Compliance with ethical standards 
  
Prior to the study’s inclusion, the patients will read and sign written informed consent 
for their involvement in this research project. Information that could reveal the patients’ 
identities was left out. The authors adhere to the APA ethical standards. 
Scientists who treat patients in private practices are not prohibited by Greek 
authorities from undertaking research projects. Private sector scientists’ research 
efforts are not reviewed by an ethical body. 
  
 
 
 
  
Statistical analysis 
  
A GLM and regression analysis should be performed to see if the therapy groups 
RECOVERYTRSGR and RECOVERYTRSBDGR are more effective and efficacious 

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in comparison to TAU and specifically which variables can explain better this efficacy 
and effectiveness. Effect sizes will also be computed. 
  
  
  
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
References 
  
1. Altman, E.G., Hedecker, D., Peterson, J.L., & Davis M. (1997). The Altman 
self- rating mania scale. Biological Psychiatry, 42, 948-955. 
2. Aster, M., Neubauer, M., & Horn R. (2006) Wechsler-Intelligenztest für 
Erwachsene WIE. Frankfurt: Harcourt Test Services. 

7 
 
3. Bech, P. (1993). Rating scales for Psychopathology, Health Status and Quality 
of Life. Berlin, Heidelberg, New York: Springer-Verlag. 
4. Busner, J., & Targum, S.D. (2007). The Clinical Global Impressions Scale. 
Applying a research tool in clinical practice. Psychiatry, 29-37. 
5. Donias, S., Karastergiou, A., & Manos N. (1991). Standardization of the 
symptom checklist-90-R rating scale in a Greek population. Psychiatriki, 2(1), 
42-48. 
6. Fountoulakis, K.N., Iacovides, A., Kleanthous, S., Samolis, S., Gougoulias, K., 
Kaprinis GSt., & Bech, P. (2003). The Greek translation of the symptoms rating 
scale for depression and anxiety: preliminary results of the validation study. 
BMC Psychiatry, 3, 21. http://www.biomedcentral.com/1471-244X/3/21. 
7. Guy, W. (ed). (1976). ECDEU Assessment. Manual for Psychopharmacology. 
Rockville, MD: US Department of Heath, Education, and Welfare Public Health 
Service Alcohol, Drug Abuse, and Mental Health Administration, 1976. 
  
8. Haddock, G., McCarron, J., Tarrier, N., Faragher, E.B. (1999). Scales to 
measure dimensions of hallucinations and delusions: the psychotic symptom 
rating scales (PSYRATS). Psychological Medicine, 29(4), 879-889. 
  
9. 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. 
10. Hancock, N., & the University of Sydney (2023). Rakitzi S. Katoudi S. Recovery 
Assessment Scale-Domains & Stages (RAS-DS). The Greek version. 
  
  
11. Kay, S.R., Fiszbein, A., & Opler LA. (1987). The positive and negative 
syndrome scale (PANSS) for schizophrenia. Schizoprenia Bulletin, 13(2), 261- 
276. 
 
12. Kosmidou, M., & Vlahou, Ch. (2010). The Greek verbal memory test. Athens: 
Parisianos. 
13. Koumpouros, Y., Papageorgiou, E., & Sakellari E. et al. (2018). Adaptation and 
psychometric properties evaluation of the Greek version of WHODAS 2.0. Pilot 

8 
 
application in Greek elderly population. Health Services and Outcomes 
Research Methodology, 18(1), 63-74. https://doi.org/10.1007/s10742-017- 
0176-x 
14. Lykouras, L., Botsis, A., & Oulis P. (2005). The PANSS Scale. Athens: 
Scientific Publications. 
15. Montgomery, S. A., & Asberg, M. (1979). A new depression scale designed to 
be sensitive to change. British Journal of Psychiatry, 134(4),382-389. 
  
16. Nuechterlein, K.H., & Green, M.F. (2006). Matrics Consensus Cognitive 
Battery. MATRICS. Los Angeles: MATRICS Assessment Inc. 
  
  
  
  
  
  
17. Rakitzi, S., & Georgila, P. (2024). Treatment resistant schizophrenia. Evidence- 
based 
pharmacotherapy, 
cognitive 
behavioral 
psychotherapy 
and 
rehabilitation. Springer. 
  
18. Rakitzi, S., & Georgila, P. (2024b). Treatment resistant bipolar disorder. 
Evidence-based pharmacotherapy, cognitive behavioral psychotherapy and 
rehabilitation. Springer. 
  
  
  
  
  
  
  
  
  
  

9 
 
19. Williams, J.B.W., & Kobak, K. A. (2008). Development and reliability of a 
structured interview guide for the Montgomery-Asberg Depression Rating 
Scale (SIGMA). The British Journal of Psychiatry, 192(1), 52-58. 
  
20. World Health Organization. International classification of functioning, disability 
and health (ICF). Geneva: World Health Organization; 2001. 
  
21. Altman, E.G., Hedecker, D., Peterson, J.L., & Davis M. (1997). The Altman 
self- rating mania scale. Biological Psychiatry, 42, 948-955. 
22. Aster, M., Neubauer, M., & Horn R. (2006) Wechsler-Intelligenztest für 
Erwachsene WIE. Frankfurt: Harcourt Test Services. 
23. Bech, P. (1993). Rating scales for Psychopathology, Health Status and Quality 
of Life. Berlin, Heidelberg, New York: Springer-Verlag. 
24. Busner, J., & Targum, S.D. (2007). The Clinical Global Impressions Scale. 
Applying a research tool in clinical practice. Psychiatry, 29-37. 
25. Donias, S., Karastergiou, A., & Manos N. (1991). Standardization of the 
symptom checklist-90-R rating scale in a Greek population. Psychiatriki, 2(1), 
42-48. 
26. Fountoulakis, K.N., Iacovides, A., Kleanthous, S., Samolis, S., Gougoulias, K., 
Kaprinis GSt., & Bech, P. (2003). The Greek translation of the symptoms rating 
scale for depression and anxiety: preliminary results of the validation study. 
BMC Psychiatry, 3, 21. http://www.biomedcentral.com/1471-244X/3/21. 
27. Guy, W. (ed). (1976). ECDEU Assessment. Manual for Psychopharmacology. 
Rockville, MD: US Department of Heath, Education, and Welfare Public Health 
Service Alcohol, Drug Abuse, and Mental Health Administration, 1976. 
  
28. Haddock, G., McCarron, J., Tarrier, N., Faragher, E.B. (1999). Scales to 
measure dimensions of hallucinations and delusions: the psychotic symptom 
rating scales (PSYRATS). Psychological Medicine, 29(4), 879-889. 
  
29. 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. 
  
  

10 
 
  
30. Hancock, N., & the University of Sydney (2023). Rakitzi S. Katoudi S. Recovery 
Assessment Scale-Domains & Stages (RAS-DS). The Greek version. 
  
  
31. Kay, S.R., Fiszbein, A., & Opler LA. (1987). The positive and negative 
syndrome scale (PANSS) for schizophrenia. Schizoprenia Bulletin, 13(2), 261- 
276. 
  
32. Kosmidou, M., & Vlahou, Ch. (2010). The Greek verbal memory test. Athens: 
Parisianos. 
33. 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 
34. Lykouras, L., Botsis, A., & Oulis P. (2005). The PANSS Scale. Athens: 
Scientific Publications. 
35. Montgomery, S. A., & Asberg, M. (1979). A new depression scale designed to 
be sensitive to change. British Journal of Psychiatry, 134(4),382-389. 
  
36. Nuechterlein, K.H., & Green, M.F. (2006). Matrics Consensus Cognitive 
Battery. MATRICS. Los Angeles: MATRICS Assessment Inc. 
  
  
  
  
  
 
 
 
 
 
  

11 
 
37. Rakitzi, S., & Georgila, P. (2024). Treatment resistant schizophrenia. Evidence- 
based 
pharmacotherapy, 
cognitive 
behavioral 
psychotherapy 
and 
rehabilitation. Springer. 
  
38. Rakitzi, S., & Georgila, P. (2024b). Treatment resistant bipolar disorder. 
Evidence-based pharmacotherapy, cognitive behavioral psychotherapy and 
rehabilitation. Springer. 
 
  
39. Williams, J.B.W., & Kobak, K. A. (2008). Development and reliability of a 
structured interview guide for the Montgomery-Asberg Depression Rating 
Scale (SIGMA). The British Journal of Psychiatry, 192(1), 52-58. 
  
40. World Health Organization. International classification of functioning, disability 
and health (ICF). Geneva: World Health Organization; 2001.