The Combination of Pharmacotherapy and Cognitive Behavioral Psychotherapy Under the Recovery Perspective.

NCT ID: NCT06993662

Last Updated: 2026-02-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

107 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-02

Study Completion Date

2027-12-20

Brief Summary

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The combination of pharmacotherapy and individual cognitive behavioral therapy in a private practice.

Detailed Description

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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.

Conditions

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Anxiety Depression Obsessive-compulsive Disorder Personality Disorder Bipolar Disorder Schizophrenia Psychotic Disorders PTSD

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Group E

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 Type EXPERIMENTAL

Group E. The combination of pharmacotherapy and individual cognitive behavioral psychotherapy by schizophrenia and psychotic disorders

Intervention Type 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 A

The combination of pharmacotherapy (anxiolytics (Tavor, clonotril, lexotanil), antidepressants (SSRI, SNRI)) and individual cognitive behavioral psychotherapy by anxiety disorders and depression.

20 patients

Group Type EXPERIMENTAL

Group A. The combination of pharmacotherapy and individual cognitive behavioral psychotherapy by anxiety disorders and depression.

Intervention Type COMBINATION_PRODUCT

The combination of pharmacotherapy (anxiolytics (tavor, clonotril, lexotanil), antidepressants (SSRI, SNRI) and individual cognitive behavioral psychotherapy by anxiety disorders and depression.

Group B

The combination of pharmacotherapy (anxiolytics (Tavor, clonotril, lexotanil), antidepressants (SSRI, SNRI)) and individual cognitive behavioral psychotherapy by PTSD.

12 patients

Group Type EXPERIMENTAL

Group B. The combination of pharmacotherapy and individual cognitive behavioral psychotherapy by PTSD

Intervention Type 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 (anxiolytics (Tavor, clonotril, lexotanil), antidepressants (SSRI, SNRI)) and individual cognitive behavioral psychotherapy by obsessive-compulsive disorder.

15 patients

Group Type EXPERIMENTAL

Group C. The combination of pharmacotherapy and individual cognitive behavioral psychotherapy by obsessive-compulsive disorder.

Intervention Type COMBINATION_PRODUCT

The combination of pharmacotherapy and individual cognitive behavioral psychotherapy by obsessive-compulsive disorder.

Group D

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

Group Type EXPERIMENTAL

Group D.The combination of pharmacotherapy and individual cognitive behavioral psychotherapy by bipolar disorder

Intervention Type 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 F

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 Type EXPERIMENTAL

Group F.The combination of pharmacotherapy and individual cognitive behavioral psychotherapy by personality disorders

Intervention Type 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.

Interventions

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Group A. The combination of pharmacotherapy and individual cognitive behavioral psychotherapy by anxiety disorders and depression.

The combination of pharmacotherapy (anxiolytics (tavor, clonotril, lexotanil), antidepressants (SSRI, SNRI) and individual cognitive behavioral psychotherapy by anxiety disorders and depression.

Intervention Type COMBINATION_PRODUCT

Group B. The combination of pharmacotherapy and individual cognitive behavioral psychotherapy by PTSD

The combination of pharmacotherapy (anxiolytics (tavor, clonotril, lexotanil), antidepressants (SSRI, SNRI) and individual cognitive behavioral psychotherapy by PTSD

Intervention Type COMBINATION_PRODUCT

Group C. The combination of pharmacotherapy and individual cognitive behavioral psychotherapy by obsessive-compulsive disorder.

The combination of pharmacotherapy and individual cognitive behavioral psychotherapy by obsessive-compulsive disorder.

Intervention Type COMBINATION_PRODUCT

Group D.The combination of pharmacotherapy and individual cognitive behavioral psychotherapy by bipolar disorder

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.

Intervention Type COMBINATION_PRODUCT

Group E. The combination of pharmacotherapy and individual cognitive behavioral psychotherapy by schizophrenia and psychotic disorders

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.

Intervention Type COMBINATION_PRODUCT

Group F.The combination of pharmacotherapy and individual cognitive behavioral psychotherapy by personality disorders

The combination of pharmacotherapy (anxiolytics (tavor, clonotril, lexotanil), antidepressants (SSRI, SNRI), antipsychotics (clozapine and atypical antipsychotics) and individual cognitive behavioral psychotherapy by personality disorders.

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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Inclusion Criteria

* age 18-65,
* IQ ≥ 80,
* Diagnosis: anxiety disorders, depression, obsessive-compulsive disorders, PTSD, personality disorders, bipolar disorders, schizophrenia and psychotic disorders.

Exclusion Criteria

\*Substance abuse and head injury.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rakitzi, Stavroula

OTHER

Sponsor Role lead

Responsible Party

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Dr. Stavroula Rakitzi

Dr. phil., Dipl.-Psych., Clinical psychologist and cognitive behavioral psychotherapist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dr. Stavroula Rakitzi, PhD

Role: STUDY_DIRECTOR

Private Practice

Dr. Polyxeni Georgila, M. D.

Role: STUDY_DIRECTOR

Private Practice

Locations

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Private practice of Dr. S. Rakitzi and Dr. P. Georgila ILISION 34 15771 ATHENS GREECE

Athens, , Greece

Site Status

Countries

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Greece

References

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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

Reference Type 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.

Reference Type BACKGROUND
PMID: 10473315 (View on PubMed)

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.

Reference Type BACKGROUND

Hancock, N., & the University of Sydney (2023). Rakitzi S. Katoudi S. Recovery Assessment Scale-Domains & Stages (RAS-DS). The Greek version.

Reference Type 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.

Reference Type BACKGROUND
PMID: 3616518 (View on PubMed)

.Kosmidou, M., & Vlahou, Ch. (2010). The Greek verbal memory test. Athens: Parisianos.

Reference Type BACKGROUND

2. Aster, M., Neubauer, M., & Horn R. (2006) Wechsler-Intelligenztest für Erwachsene WIE. Frankfurt: Harcourt Test Services.

Reference Type 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.

Reference Type BACKGROUND
PMID: 9359982 (View on PubMed)

Bech, P. (1993). Rating scales for Psychopathology, Health Status and Quality of Life. Berlin, Heidelberg, New York: Springer-Verlag.

Reference Type 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.

Reference Type BACKGROUND
PMID: 20526405 (View on PubMed)

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

Reference Type 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.

Reference Type BACKGROUND
PMID: 14667249 (View on PubMed)

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

Reference Type BACKGROUND

.Lykouras, L., Botsis, A., & Oulis P. (2005). The PANSS Scale. Athens: Scientific Publications

Reference Type 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.

Reference Type BACKGROUND
PMID: 444788 (View on PubMed)

Rakitzi, S. (2023). Clinical psychology and cognitive behavioral psychotherapy. Recovery in mental health. Springer

Reference Type 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.

Reference Type BACKGROUND
PMID: 18174510 (View on PubMed)

World Health Organization. International classification of functioning, disability and health (ICF). Geneva: World Health Organization; 2001

Reference Type 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.

Reference Type BACKGROUND
PMID: 728692 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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RAKITZI & GEORGILA CBT

Identifier Type: -

Identifier Source: org_study_id

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