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Active, Not Recruiting

NCT Number: NCT06993662

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

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Anxiety Anxiety Disorders Behavior Behavioral Symptoms Bipolar Disorder Bipolar and Related Disorders Depression Mental Disorders Mood Disorders Obsessive-Compulsive Disorder PTSD Personality Disorder Personality Disorders Psychotic Disorders Schizophrenia Schizophrenia Spectrum and Other Psychotic Disorders Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

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

Athens, 15771, Greece

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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 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.

Primary outcomes

  1. MCCB BACS symbol coding

    Time frame: Preintervention

    It measures speed of processing. Minimum 0, maximum 110, high scores better

  2. MCCB BACS symbol coding

    Time frame: Immediately after the intervention

    It measures speed of processing. Minimum 0, maximum 110, high scores better

  3. MCCB BACS symbol coding

    Time frame: Follow-up up to 24 weeks

    It measures speed of processing. Minimum 0, maximum 110, high scores better

  4. MCCB Wechsler memory scale-spatial span

    Time frame: Preintervention

    It measures non-verbal working memory. Minimum 0, maximum 32, high scores better, Summary of forward and backward total score.

  5. MCCB Wechsler memory scale-spatial span

    Time frame: Immediately after the intervention

    It measures non-verbal working memory. Minimum 0, maximum 32, high scores better, Summary of forward and backward total score.

  6. MCCB Wechsler memory scale-spatial span

    Time frame: Follow-up up to 24 weeks

    It measures non-verbal working memory. Minimum 0, maximum 32, high scores better, Summary of forward and backward total score.

  7. MCCB Neurospychological Assessment Battery (NAB)

    Time frame: Preintervention

    It measures reasoning and problem-solving. Minimum 0, maximum 26. high scores better

  8. MCCB Neurospychological Assessment Battery (NAB)

    Time frame: Immediately after the intervention

    It measures reasoning and problem-solving. Minimum 0, maximum 26. high scores better

  9. MCCB Neurospychological Assessment Battery (NAB)

    Time frame: Follow-up up to 24 weeks

    It measures reasoning and problem-solving. Minimum 0, maximum 26. high scores better

  10. MCCB Brief visuospatial memory test

    Time frame: Preintervention

    It measures visual memory. Sum of Trial 1, 2, 3. Minimum 0, maximum 12. high scores better

  11. MCCB Brief visuospatial memory test

    Time frame: Immediately after the intervention

    It measures visual memory. Sum of Trial 1, 2, 3. Minimum 0, maximum 12. high scores better

  12. MCCB Brief visuospatial memory test

    Time frame: Follow-up up to 24 weeks

    It measures visual memory. Sum of Trial 1, 2, 3. Minimum 0, maximum 12. high scores better

  13. The Greek verbal memory test

    Time frame: Preintervention

    It measures oral verbal memory. Semantic. Sum of the 3 categories divided to 3. Minimum 0, maximum 40. high scores better.

  14. The Greek verbal memory test

    Time frame: Immediately after the intervention

    It measures oral verbal memory. Semantic. Sum of the 3 categories divided to 3. Minimum 0, maximum 40. high scores better.

  15. The Greek verbal memory test

    Time frame: Follow-up up to 24 weeks

    It measures oral verbal memory. Semantic. Sum of the 3 categories divided to 3. Minimum 0, maximum 40. high scores better.

  16. The Greek verbal memory test

    Time frame: Preintervention

    It measures oral verbal memory. Semantic. Sum of the 3 categories divided to 3. Minimum 0, maximum 40. high scores better

  17. The Greek verbal memory test

    Time frame: Immediately after the intervention

    It measures oral verbal memory. Semantic. Sum of the 3 categories divided to 3. Minimum 0, maximum 40. high scores better

  18. The Greek verbal memory test

    Time frame: Follow-up up to 24 weeks

    It measures oral verbal memory. Semantic. Sum of the 3 categories divided to 3. Minimum 0, maximum 40. high scores better

  19. The Greek verbal memory test

    Time frame: Preintervention

    It measures oral verbal memory. Phonological. Sum of the 3 categories divided to 3. Minimum 0, maximum 40. high scores better

  20. The Greek verbal memory test

    Time frame: Immediately after the intervention

    It measures oral verbal memory. Phonological. Sum of the 3 categories divided to 3. Minimum 0, maximum 40. high scores better

  21. The Greek verbal memory test

    Time frame: Follow-up up to 24 weeks

    It measures oral verbal memory. Phonological. Sum of the 3 categories divided to 3. Minimum 0, maximum 40. high scores better

  22. The Greek verbal memory test

    Time frame: Preintervention

    It measures written verbal memory. Sum of the 2 tasks. Minimum 0, maximum as much as possible. high scores better.

  23. The Greek verbal memory test

    Time frame: Immediately after the intervention

    It measures written verbal memory. Sum of the 2 tasks. Minimum 0, maximum as much as possible. high scores better.

  24. The Greek verbal memory test

    Time frame: Follow-up up to 24 weeks

    It measures written verbal memory. Sum of the 2 tasks. Minimum 0, maximum as much as possible. high scores better.

  25. SCL-90-R

    Time frame: Preintervention

    It evaluates psychopathology. T>60 means psychopathology. Low scores better

  26. SCL-90-R

    Time frame: Immediately after the intervention

    It evaluates psychopathology. T>60 means psychopathology. Low scores better

  27. SCL-90-R

    Time frame: Follow-up up to 24 weeks

    It evaluates psychopathology. T>60 means psychopathology. Low scores better

  28. PANNS total

    Time frame: Preintervention

    It measures positive, negative symptoms and general psychopathology. Minimum 31, maximum 210. Low scores better

  29. PANNS total

    Time frame: Immediately after the intervention

    It measures positive, negative symptoms and general psychopathology. Minimum 31, maximum 210. Low scores better

  30. PANNS total

    Time frame: Follow-up up to 24 weeks

    It measures positive, negative symptoms and general psychopathology. Minimum 31, maximum 210. Low scores better

  31. WHODAS total

    Time frame: Preintervention

    It measures functional outcome. Minimum 0, maximum 100. low scores better.

  32. WHODAS total

    Time frame: Immediately after the intervention

    It measures functional outcome. Minimum 0, maximum 100. low scores better.

  33. WHODAS total

    Time frame: Follow-up up to 24 weeks

    It measures functional outcome. Minimum 0, maximum 100. low scores better.

  34. RAS-DS total

    Time frame: Preintervention

    It measures recovery. Minimum 0, maximum 152. High scores better.

  35. RAS-DS total

    Time frame: Immediately after the intervention

    It measures recovery. Minimum 0, maximum 152. High scores better.

  36. RAS-DS total

    Time frame: Follow-up up to 24 weeks

    It measures recovery. Minimum 0, maximum 152. High scores better.

  37. The Clinical Global Impression Scale (CGI)

    Time frame: Preintervention

    It measures severity of illness. Minimum 0, Maximum 7, low scores better.

  38. The Clinical Global Impression Scale (CGI)

    Time frame: Immediately after the intervention

    It measures severity of illness. Minimum 0, Maximum 7, low scores better.

  39. The Clinical Global Impression Scale (CGI)

    Time frame: Follow-up up to 24 weeks

    It measures severity of illness. Minimum 0, Maximum 7, low scores better.

  40. The Clinical Global Impression Scale (CGI)

    Time frame: Preintervention

    It measures global improvement. Minimum 0, Maximum 7, low scores better.

  41. The Clinical Global Impression Scale (CGI)

    Time frame: Immediately after the intervention

    It measures global improvement. Minimum 0, Maximum 7, low scores better.

  42. The Clinical Global Impression Scale (CGI)

    Time frame: Follow-up up to 24 weeks

    It measures global improvement. Minimum 0, Maximum 7, low scores better.

  43. SRSDA

    Time frame: Preintervention

    It measures Depression. Minimum 0, maximum 14 or higher. Low scores better

  44. SRSDA

    Time frame: Immediately after the intervention

    It measures Depression. Minimum 0, maximum 14 or higher. Low scores better

  45. SRSDA

    Time frame: Follow-up up to 24 weeks

    It measures Depression. Minimum 0, maximum 14 or higher. Low scores better

  46. SRSDA B

    Time frame: Preintervention

    It measures Anxiety. Minimum 0, maximum 10 or higher. Low scores better

  47. SRSDA B

    Time frame: Immediately after the intervention

    It measures Anxiety. Minimum 0, maximum 10 or higher. Low scores better

  48. SRSDA B

    Time frame: Follow-up up to 24 weeks

    It measures Anxiety. Minimum 0, maximum 10 or higher. Low scores better

  49. Hamilton Depression Scale

    Time frame: Preintervention

    It measures depression. Minimum 0, maximum 23. Low scores better.

  50. Hamilton Depression Scale

    Time frame: Immediately after the intervention

    It measures depression. Minimum 0, maximum 23. Low scores better.

  51. Hamilton Depression Scale

    Time frame: Follow-up up to 24 weeks

    It measures depression. Minimum 0, maximum 23. Low scores better.

  52. Montgomery and Asperg depression scale

    Time frame: Preintervention

    It measures depression. Minimum 0, maximum 60. Low scores better.

  53. Montgomery and Asperg depression scale

    Time frame: Immediately after the intervention

    It measures depression. Minimum 0, maximum 60. Low scores better.

  54. Montgomery and Asperg depression scale

    Time frame: Follow-up up to 24 weeks

    It measures depression. Minimum 0, maximum 60. Low scores better.

  55. The Altman self-rating scale

    Time frame: Preintervention

    It measures mania. Minimum 0, maximum 6 or higher. Low scores better.

  56. The Altman self-rating scale

    Time frame: Immediately after the intervention

    It measures mania. Minimum 0, maximum 6 or higher. Low scores better.

  57. The Altman self-rating scale

    Time frame: Follow-up up to 24 weeks

    It measures mania. Minimum 0, maximum 6 or higher. Low scores better.

  58. The Young mania rating scale

    Time frame: Preintervention

    It measures mania. Minimum 0, maximum 60. Low scores better

  59. The Young mania rating scale

    Time frame: Immediately after the intervention

    It measures mania. Minimum 0, maximum 60. Low scores better

  60. The Young mania rating scale

    Time frame: Follow-up up to 24 weeks

    It measures mania. Minimum 0, maximum 60. Low scores better

  61. PSYRAT H

    Time frame: Preintervention

    It measures psychotic symptoms. Hallucinations. Minimum 0, maximum 24. Low scores better.

  62. PSYRAT H

    Time frame: Immediately after the intervention

    It measures psychotic symptoms. Hallucinations. Minimum 0, maximum 24. Low scores better.

  63. PSYRAT H

    Time frame: Follow-up up to 24 weeks

    It measures psychotic symptoms. Hallucinations. Minimum 0, maximum 24. Low scores better.

  64. PSYRAT D

    Time frame: Preintervention

    It measures psychotic symptoms. Delusions. Minimum 0, maximum 44. Low scores better

  65. PSYRAT D

    Time frame: Immediately after the intervention

    It measures psychotic symptoms. Delusions. Minimum 0, maximum 44. Low scores better

  66. PSYRAT D

    Time frame: Follow-up up to 24 weeks

    It measures psychotic symptoms. Delusions. Minimum 0, maximum 44. Low scores better

Secondary outcomes

  1. WAIS

    Time frame: Preintervention

    It measures the Intelligenz-quotient. For bipolar disorder, schizophrenia and psychotic disorders

Sponsors and collaborators

Lead sponsor

Rakitzi, Stavroula

Other

Registry information

Official study title

The Effectiveness and Efficacy of the Combination of Pharmacotherapy and Cognitive Behavioral Psychotherapy Under the Recovery Perspective for Patients With Mental Health Disorders

Acronym: RAKGEOCBT

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
May 29, 2025
Registry last updated
May 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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