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The combination of pharmacotherapy and individual cognitive behavioral therapy in a private practice.
Reintegration into society and good functional outcome by people with mental health disorders is frequently the result of the combination of pharmacotherapy and individual cognitive behavioral psychotherapy. The effectiveness and efficacy of this combination of treatments under the recovery perspective by anxiety disorders, depressive disorders, PTSD, bipolar disorders, schizophrenia and psychotic disorders, by obsessive-compulsive disorders and by personality disorders presents the main goal of this research protocol. Recovery means that people learn through the trherapy to be responsible towards their own problems.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | The combination of pharmacotherapy (anxiolytics (Tavor, clonotril, lexotanil), antidepressants (SSRI, SNRI)) and individual cognitive behavioral psychotherapy by anxiety disorders and depression. 20 patients |
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| Group B | Experimental | The combination of pharmacotherapy (anxiolytics (Tavor, clonotril, lexotanil), antidepressants (SSRI, SNRI)) and individual cognitive behavioral psychotherapy by PTSD. 12 patients |
|
| Group C | Experimental | The combination of pharmacotherapy (anxiolytics (Tavor, clonotril, lexotanil), antidepressants (SSRI, SNRI)) and individual cognitive behavioral psychotherapy by obsessive-compulsive disorder. 15 patients |
|
| Group D | Experimental | The combination of pharmacotherapy (anxiolytics ((Tavor, clonotril, lexotanil), antidperessants (SSRI, SNRI), mood stabilizers (Lithium, depakine) and antipsychotics (clozapine and atypical antipsychotics)) and individual cognitive behavioral psychotherapy by bipolar disorders. 15 patients |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Group A. The combination of pharmacotherapy and individual cognitive behavioral psychotherapy by anxiety disorders and depression. | Combination Product | The combination of pharmacotherapy (anxiolytics (tavor, clonotril, lexotanil), antidepressants (SSRI, SNRI) and individual cognitive behavioral psychotherapy by anxiety disorders and depression. |
| Measure | Description | Time Frame |
|---|---|---|
| MCCB BACS symbol coding | It measures speed of processing. Minimum 0, maximum 110, high scores better | Preintervention |
| MCCB BACS symbol coding | It measures speed of processing. Minimum 0, maximum 110, high scores better | Immediately after the intervention |
| MCCB BACS symbol coding | It measures speed of processing. Minimum 0, maximum 110, high scores better | Follow-up up to 24 weeks |
| MCCB Wechsler memory scale-spatial span | It measures non-verbal working memory. Minimum 0, maximum 32, high scores better, Summary of forward and backward total score. | Preintervention |
| MCCB Wechsler memory scale-spatial span | It measures non-verbal working memory. Minimum 0, maximum 32, high scores better, Summary of forward and backward total score. | Immediately after the intervention |
| MCCB Wechsler memory scale-spatial span | It measures non-verbal working memory. Minimum 0, maximum 32, high scores better, Summary of forward and backward total score. | Follow-up up to 24 weeks |
| MCCB Neurospychological Assessment Battery (NAB) | It measures reasoning and problem-solving. Minimum 0, maximum 26. high scores better | Preintervention |
| Measure | Description | Time Frame |
|---|---|---|
| WAIS | It measures the Intelligenz-quotient. For bipolar disorder, schizophrenia and psychotic disorders | Preintervention |
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Inclusion Criteria:
Exclusion Criteria:
*Substance abuse and head injury.
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| Name | Affiliation | Role |
|---|---|---|
| Dr. Stavroula Rakitzi, PhD | Private Practice | Study Director |
| Dr. Polyxeni Georgila, M. D. | Private Practice | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Private practice of Dr. S. Rakitzi and Dr. P. Georgila ILISION 34 15771 ATHENS GREECE | Athens | 15771 | Greece |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 2. Aster, M., Neubauer, M., & Horn R. (2006) Wechsler-Intelligenztest für Erwachsene WIE. Frankfurt: Harcourt Test Services. | ||
| 9359982 | Background | Altman EG, Hedeker D, Peterson JL, Davis JM. The Altman Self-Rating Mania Scale. Biol Psychiatry. 1997 Nov 15;42(10):948-55. doi: 10.1016/S0006-3223(96)00548-3. | |
| Background | Bech, P. (1993). Rating scales for Psychopathology, Health Status and Quality of Life. Berlin, Heidelberg, New York: Springer-Verlag. | ||
| 20526405 |
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This is our first effectiveness study regarding pharmacotherapy and cognitive behavioral psychotherapy in our private practice.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 23, 2025 |
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| Group E | Experimental | The combination of pharmacotherapy (antipsychotics (clozapine and atypical antipsychotics)) , anxiolytics (Tavor, clonotril, lexotanil), antidepressants (SSRI, SNRI)) and individual cognitive behavioral psychotherapy by schizophrenia and psychotic disorders. 20 patients |
|
| Group F | Experimental | The combination of pharmacotherapy (antidepressants (SSRI, SNRI), anxiolytics (Tavor, clonotril, lexotanil) antipsychotics (clozapine and atypical antipsychotics)) and individual cognitive behavioral psychotherapy by personality disorders. 20 patients (2 narcistic personality disorder, 5 borderline personality disorder, 4 obsessive-compulsive disorder, 5 avoidant personality disorder, 4 depedent personality disorder) |
|
|
| Group B. The combination of pharmacotherapy and individual cognitive behavioral psychotherapy by PTSD | Combination Product | The combination of pharmacotherapy (anxiolytics (tavor, clonotril, lexotanil), antidepressants (SSRI, SNRI) and individual cognitive behavioral psychotherapy by PTSD |
|
| Group C. The combination of pharmacotherapy and individual cognitive behavioral psychotherapy by obsessive-compulsive disorder. | Combination Product | The combination of pharmacotherapy and individual cognitive behavioral psychotherapy by obsessive-compulsive disorder. |
|
| Group D.The combination of pharmacotherapy and individual cognitive behavioral psychotherapy by bipolar disorder | Combination Product | The combination of pharmacotherapy (anxiolytics (tavor, clonotril, lexotanil) antidepressants (SSRI, SNRI), mood stabilizers (lithium, depakine), antipsychotics (clozapine and atypical antipsychotics)) and individual cognitive behavioral psychotherapy by bipolar disorder. |
|
| Group E. The combination of pharmacotherapy and individual cognitive behavioral psychotherapy by schizophrenia and psychotic disorders | Combination Product | The combination of pharmacotherapy (anxiolytics(tavor, clonotril, lexotanil), antidepressants (SSRI, SNRI), antipsychotics (clozapine and atypical antipsychotics)) and individual cognitive behavioral psychotherapy by schizophrenia and psychotic disorders. |
|
| Group F.The combination of pharmacotherapy and individual cognitive behavioral psychotherapy by personality disorders | Combination Product | The combination of pharmacotherapy (anxiolytics (tavor, clonotril, lexotanil), antidepressants (SSRI, SNRI), antipsychotics (clozapine and atypical antipsychotics) and individual cognitive behavioral psychotherapy by personality disorders. |
|
| MCCB Neurospychological Assessment Battery (NAB) | It measures reasoning and problem-solving. Minimum 0, maximum 26. high scores better | Immediately after the intervention |
| MCCB Neurospychological Assessment Battery (NAB) | It measures reasoning and problem-solving. Minimum 0, maximum 26. high scores better | Follow-up up to 24 weeks |
| MCCB Brief visuospatial memory test | It measures visual memory. Sum of Trial 1, 2, 3. Minimum 0, maximum 12. high scores better | Preintervention |
| MCCB Brief visuospatial memory test | It measures visual memory. Sum of Trial 1, 2, 3. Minimum 0, maximum 12. high scores better | Immediately after the intervention |
| MCCB Brief visuospatial memory test | It measures visual memory. Sum of Trial 1, 2, 3. Minimum 0, maximum 12. high scores better | Follow-up up to 24 weeks |
| The Greek verbal memory test | It measures oral verbal memory. Semantic. Sum of the 3 categories divided to 3. Minimum 0, maximum 40. high scores better. | Preintervention |
| The Greek verbal memory test | It measures oral verbal memory. Semantic. Sum of the 3 categories divided to 3. Minimum 0, maximum 40. high scores better. | Immediately after the intervention |
| The Greek verbal memory test | It measures oral verbal memory. Semantic. Sum of the 3 categories divided to 3. Minimum 0, maximum 40. high scores better. | Follow-up up to 24 weeks |
| The Greek verbal memory test | It measures oral verbal memory. Semantic. Sum of the 3 categories divided to 3. Minimum 0, maximum 40. high scores better | Preintervention |
| The Greek verbal memory test | It measures oral verbal memory. Semantic. Sum of the 3 categories divided to 3. Minimum 0, maximum 40. high scores better | Immediately after the intervention |
| The Greek verbal memory test | It measures oral verbal memory. Semantic. Sum of the 3 categories divided to 3. Minimum 0, maximum 40. high scores better | Follow-up up to 24 weeks |
| The Greek verbal memory test | It measures oral verbal memory. Phonological. Sum of the 3 categories divided to 3. Minimum 0, maximum 40. high scores better | Preintervention |
| The Greek verbal memory test | It measures oral verbal memory. Phonological. Sum of the 3 categories divided to 3. Minimum 0, maximum 40. high scores better | Immediately after the intervention |
| The Greek verbal memory test | It measures oral verbal memory. Phonological. Sum of the 3 categories divided to 3. Minimum 0, maximum 40. high scores better | Follow-up up to 24 weeks |
| The Greek verbal memory test | It measures written verbal memory. Sum of the 2 tasks. Minimum 0, maximum as much as possible. high scores better. | Preintervention |
| The Greek verbal memory test | It measures written verbal memory. Sum of the 2 tasks. Minimum 0, maximum as much as possible. high scores better. | Immediately after the intervention |
| The Greek verbal memory test | It measures written verbal memory. Sum of the 2 tasks. Minimum 0, maximum as much as possible. high scores better. | Follow-up up to 24 weeks |
| SCL-90-R | It evaluates psychopathology. T>60 means psychopathology. Low scores better | Preintervention |
| SCL-90-R | It evaluates psychopathology. T>60 means psychopathology. Low scores better | Immediately after the intervention |
| SCL-90-R | It evaluates psychopathology. T>60 means psychopathology. Low scores better | Follow-up up to 24 weeks |
| PANNS total | It measures positive, negative symptoms and general psychopathology. Minimum 31, maximum 210. Low scores better | Preintervention |
| PANNS total | It measures positive, negative symptoms and general psychopathology. Minimum 31, maximum 210. Low scores better | Immediately after the intervention |
| PANNS total | It measures positive, negative symptoms and general psychopathology. Minimum 31, maximum 210. Low scores better | Follow-up up to 24 weeks |
| WHODAS total | It measures functional outcome. Minimum 0, maximum 100. low scores better. | Preintervention |
| WHODAS total | It measures functional outcome. Minimum 0, maximum 100. low scores better. | Immediately after the intervention |
| WHODAS total | It measures functional outcome. Minimum 0, maximum 100. low scores better. | Follow-up up to 24 weeks |
| RAS-DS total | It measures recovery. Minimum 0, maximum 152. High scores better. | Preintervention |
| RAS-DS total | It measures recovery. Minimum 0, maximum 152. High scores better. | Immediately after the intervention |
| RAS-DS total | It measures recovery. Minimum 0, maximum 152. High scores better. | Follow-up up to 24 weeks |
| The Clinical Global Impression Scale (CGI) | It measures severity of illness. Minimum 0, Maximum 7, low scores better. | Preintervention |
| The Clinical Global Impression Scale (CGI) | It measures severity of illness. Minimum 0, Maximum 7, low scores better. | Immediately after the intervention |
| The Clinical Global Impression Scale (CGI) | It measures severity of illness. Minimum 0, Maximum 7, low scores better. | Follow-up up to 24 weeks |
| The Clinical Global Impression Scale (CGI) | It measures global improvement. Minimum 0, Maximum 7, low scores better. | Preintervention |
| The Clinical Global Impression Scale (CGI) | It measures global improvement. Minimum 0, Maximum 7, low scores better. | Immediately after the intervention |
| The Clinical Global Impression Scale (CGI) | It measures global improvement. Minimum 0, Maximum 7, low scores better. | Follow-up up to 24 weeks |
| SRSDA | It measures Depression. Minimum 0, maximum 14 or higher. Low scores better | Preintervention |
| SRSDA | It measures Depression. Minimum 0, maximum 14 or higher. Low scores better | Immediately after the intervention |
| SRSDA | It measures Depression. Minimum 0, maximum 14 or higher. Low scores better | Follow-up up to 24 weeks |
| SRSDA B | It measures Anxiety. Minimum 0, maximum 10 or higher. Low scores better | Preintervention |
| SRSDA B | It measures Anxiety. Minimum 0, maximum 10 or higher. Low scores better | Immediately after the intervention |
| SRSDA B | It measures Anxiety. Minimum 0, maximum 10 or higher. Low scores better | Follow-up up to 24 weeks |
| Hamilton Depression Scale | It measures depression. Minimum 0, maximum 23. Low scores better. | Preintervention |
| Hamilton Depression Scale | It measures depression. Minimum 0, maximum 23. Low scores better. | Immediately after the intervention |
| Hamilton Depression Scale | It measures depression. Minimum 0, maximum 23. Low scores better. | Follow-up up to 24 weeks |
| Montgomery and Asperg depression scale | It measures depression. Minimum 0, maximum 60. Low scores better. | Preintervention |
| Montgomery and Asperg depression scale | It measures depression. Minimum 0, maximum 60. Low scores better. | Immediately after the intervention |
| Montgomery and Asperg depression scale | It measures depression. Minimum 0, maximum 60. Low scores better. | Follow-up up to 24 weeks |
| The Altman self-rating scale | It measures mania. Minimum 0, maximum 6 or higher. Low scores better. | Preintervention |
| The Altman self-rating scale | It measures mania. Minimum 0, maximum 6 or higher. Low scores better. | Immediately after the intervention |
| The Altman self-rating scale | It measures mania. Minimum 0, maximum 6 or higher. Low scores better. | Follow-up up to 24 weeks |
| The Young mania rating scale | It measures mania. Minimum 0, maximum 60. Low scores better | Preintervention |
| The Young mania rating scale | It measures mania. Minimum 0, maximum 60. Low scores better | Immediately after the intervention |
| The Young mania rating scale | It measures mania. Minimum 0, maximum 60. Low scores better | Follow-up up to 24 weeks |
| PSYRAT H | It measures psychotic symptoms. Hallucinations. Minimum 0, maximum 24. Low scores better. | Preintervention |
| PSYRAT H | It measures psychotic symptoms. Hallucinations. Minimum 0, maximum 24. Low scores better. | Immediately after the intervention |
| PSYRAT H | It measures psychotic symptoms. Hallucinations. Minimum 0, maximum 24. Low scores better. | Follow-up up to 24 weeks |
| PSYRAT D | It measures psychotic symptoms. Delusions. Minimum 0, maximum 44. Low scores better | Preintervention |
| PSYRAT D | It measures psychotic symptoms. Delusions. Minimum 0, maximum 44. Low scores better | Immediately after the intervention |
| PSYRAT D | It measures psychotic symptoms. Delusions. Minimum 0, maximum 44. Low scores better | Follow-up up to 24 weeks |
| Background |
| Busner J, Targum SD. The clinical global impressions scale: applying a research tool in clinical practice. Psychiatry (Edgmont). 2007 Jul;4(7):28-37. |
| Background | 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 |
| 14667249 | Background | Fountoulakis KN, Iacovides A, Kleanthous S, Samolis S, Gougoulias K, St Kaprinis G, Bech P. The Greek translation of the symptoms rating scale for depression and anxiety: preliminary results of the validation study. BMC Psychiatry. 2003 Dec 10;3:21. doi: 10.1186/1471-244X-3-21. |
| Background | 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 |
| 10473315 | Background | 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. |
| Background | 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. |
| Background | Hancock, N., & the University of Sydney (2023). Rakitzi S. Katoudi S. Recovery Assessment Scale-Domains & Stages (RAS-DS). The Greek version. |
| 3616518 | Background | Kay SR, Fiszbein A, Opler LA. The positive and negative syndrome scale (PANSS) for schizophrenia. Schizophr Bull. 1987;13(2):261-76. doi: 10.1093/schbul/13.2.261. |
| Background | .Kosmidou, M., & Vlahou, Ch. (2010). The Greek verbal memory test. Athens: Parisianos. |
| Background | 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 |
| Background | .Lykouras, L., Botsis, A., & Oulis P. (2005). The PANSS Scale. Athens: Scientific Publications |
| 444788 | Background | Montgomery SA, Asberg M. A new depression scale designed to be sensitive to change. Br J Psychiatry. 1979 Apr;134:382-9. doi: 10.1192/bjp.134.4.382. |
| Background | Rakitzi, S. (2023). Clinical psychology and cognitive behavioral psychotherapy. Recovery in mental health. Springer |
| 18174510 | Background | Williams JB, Kobak KA. Development and reliability of a structured interview guide for the Montgomery Asberg Depression Rating Scale (SIGMA). Br J Psychiatry. 2008 Jan;192(1):52-8. doi: 10.1192/bjp.bp.106.032532. |
| Background | World Health Organization. International classification of functioning, disability and health (ICF). Geneva: World Health Organization; 2001 |
| 728692 | Background | Young RC, Biggs JT, Ziegler VE, Meyer DA. A rating scale for mania: reliability, validity and sensitivity. Br J Psychiatry. 1978 Nov;133:429-35. doi: 10.1192/bjp.133.5.429. |
| Apr 23, 2025 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 23, 2025 | Apr 23, 2025 | ICF_001.pdf |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D003863 | Depression |
| D009771 | Obsessive-Compulsive Disorder |
| D010554 | Personality Disorders |
| D001714 | Bipolar Disorder |
| D012559 | Schizophrenia |
| D011618 | Psychotic Disorders |
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
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