NCT06993662

Brief Summary

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

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
107

participants targeted

Target at P75+ for phase_1 anxiety

Timeline
20mo left

Started Jun 2025

Longer than P75 for phase_1 anxiety

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress37%
Jun 2025Dec 2027

First Submitted

Initial submission to the registry

April 23, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 29, 2025

Completed
4 days until next milestone

Study Start

First participant enrolled

June 2, 2025

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2027

Last Updated

May 7, 2026

Status Verified

April 1, 2026

Enrollment Period

2.6 years

First QC Date

April 23, 2025

Last Update Submit

April 30, 2026

Conditions

AnxietyDepressionPersonality DisorderObsessive-compulsive DisorderBipolar DisorderSchizophreniaPsychotic DisordersPTSD

Keywords

PharmacotherapyCognitive behavioral psychotherapyRecovery

Outcome Measures

Primary Outcomes (66)

  • 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

  • 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

Secondary Outcomes (1)

  • WAIS

    Preintervention

Study Arms (6)

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

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

Group B

EXPERIMENTAL

The combination of pharmacotherapy (anxiolytics (Tavor, clonotril, lexotanil), antidepressants (SSRI, SNRI)) and individual cognitive behavioral psychotherapy by PTSD. 12 patients

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

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

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

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

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

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

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

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)

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

Interventions

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.

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

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

Group B
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 C
Group D.The combination of pharmacotherapy and individual cognitive behavioral psychotherapy by bipolar disorderCOMBINATION_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 D
Group E. The combination of pharmacotherapy and individual cognitive behavioral psychotherapy by schizophrenia and psychotic disordersCOMBINATION_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 E
Group F.The combination of pharmacotherapy and individual cognitive behavioral psychotherapy by personality disordersCOMBINATION_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.

Group F

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • \*Substance abuse and head injury.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Athens, 15771, Greece

Location

Related Publications (19)

  • 2. Aster, M., Neubauer, M., & Horn R. (2006) Wechsler-Intelligenztest fĂ¼r Erwachsene WIE. Frankfurt: Harcourt Test Services.

    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.

    PMID: 9359982BACKGROUND

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

    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.

    PMID: 20526405BACKGROUND

  • 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

    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.

    PMID: 14667249BACKGROUND

  • 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

    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.

    PMID: 10473315BACKGROUND

  • 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.

    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.

    PMID: 3616518BACKGROUND

  • .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

    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.

    PMID: 444788BACKGROUND

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

    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.

    PMID: 18174510BACKGROUND

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

    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.

    PMID: 728692BACKGROUND

MeSH Terms

Conditions

Anxiety DisordersDepressionObsessive-Compulsive DisorderPersonality DisordersBipolar DisorderSchizophreniaPsychotic DisordersStress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Mental DisordersBehavioral SymptomsBehaviorBipolar and Related DisordersMood DisordersSchizophrenia Spectrum and Other Psychotic DisordersStress Disorders, TraumaticTrauma and Stressor Related Disorders

Study Officials

  • Dr. Stavroula Rakitzi, PhD

    Private Practice

    STUDY DIRECTOR

  • Dr. Polyxeni Georgila, M. D.

    Private Practice

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. phil., Dipl.-Psych., Clinical psychologist and cognitive behavioral psychotherapist

Study Record Dates

First Submitted

April 23, 2025

First Posted

May 29, 2025

Study Start

June 2, 2025

Primary Completion (Estimated)

December 20, 2027

Study Completion (Estimated)

December 20, 2027

Last Updated

May 7, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

This is our first effectiveness study regarding pharmacotherapy and cognitive behavioral psychotherapy in our private practice.

Locations

GR(1)