Trial Outcomes & Findings for The Effectiveness and Efficacy of the Combination of the Integrated Psychological Therapy and Metacognitive Training. (NCT NCT05623228)
NCT ID: NCT05623228
Last Updated: 2025-03-05
Results Overview
Greek verbal memory test: (verbal memory semantic condition (average) (minimum 0-maximum 40) (high scores better outcomes) MCCB: (Neuropsychological Assessment Battery) (NAB) (reasoning and problem solving): (minimum 0 maximum 26) (high scores better outcomes) Data is analyzed through SPS 13.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
35 participants
Primary outcome timeframe
Baseline T1 (preintervention)-follow-up T3 (after 6 months, up to 55 weeks)
Results posted on
2025-03-05
Participant Flow
November 2022-Januar 2023 Patients were recruited from our private practice Dr. Stavroula Rakitzi Dr. Polyxeni Georgila
35 patients with schizophrenia started
Participant milestones
| Measure |
Therapy Group A
Therapy Group A Intervention: Pharmacotherapy in combination with the Integrated Psychological Therapy and Metacognitive Training will be implemented.
Monthly psychiatric treatment twice a week IPT and MCT, 60 minutes every session
1. clozapine 350mg, amisulpride 200mg, mirtazapine 30 mg, clonazepam 2 mg
2. olanzapine 22, 5 mg, alprazolami 0, 50 mg
3. clozapine 200mg, 400 mg amisulpride, citalopram 20 mg, clonazepam 2 mg
4. clozapine 300 mg, amisulpride 400mg
5. 250mg clozapine, cariprazime 4, 5mg
The combination of the Integrated Psychological Therapy and Metacognitive Training in individuals with schizophrenia and treatment resistant schizophrenia: The combination of pharmacotherapy and psychotherapy in individuals with schizophrenia and treatment resistant schizophrenia.
Therapy period: November 2022-June 2023 Preevaluation: 1 November 2022 Postevaluation: June 2023 Follow up evaluation Januar 2024
|
Therapy Group B
Therapy Group B Intervention: Pharmacotherapy in combination with the Integrated Psychological Therapy and Metacognitive Training will be implemented.
Monthly psychiatric treatment twice a week IPT and MCT, 60 minutes every session
The combination of the Integrated Psychological Therapy and Metacognitive Training in individuals with schizophrenia and treatment resistant schizophrenia: The combination of pharmacotherapy and psychotherapy in individuals with schizophrenia and treatment resistant schizophrenia.
Therapy period: November 2022-June 2023 Preevaluation: 1 November 2022 Postevaluation: June 2023 Follow up evaluation Januar 2024
1. olanzapine 10 mg
2. clozapine 350 mg, alprazolami 0, 5mg
|
Therapy Group C
Therapy Group C Intervention: Pharmacotherapy in combination with the Integrated Psychological Therapy and Metacognitive Training will be implemented.
Monthly psychiatric treatment twice a week IPT and MCT, 60 minutes every session
The combination of the Integrated Psychological Therapy and Metacognitive Training in individuals with schizophrenia and treatment resistant schizophrenia: The combination of pharmacotherapy and psychotherapy in individuals with schizophrenia and treatment resistant schizophrenia.
Therapy period: November 2022-June 2023 Preevaluation: 1 November 2022 Postevaluation: June 2023 Follow up evaluation Januar 2024
1. Clozapine 250 mg, aripiprazole 10 mg, alprazolam 0.5 mg
2. olanzapine 30 mg, amisulpride 400 mg
3. perphenazine 16 mg, olanzapine 10 mg, amitriptyline 40 mg
4. perphenazine 12 mg, amitriptyline 30 mg, olanzapine 15 mg
5. aripripazole depot 400 mg, zypahera 405 mg depot
6. 2 aripripazole depot 400mg (800)
7. clozapine 400 mg, valproide natrio 1000 mg, stelazine 15 mg
8. clozapine 300 mg, risperidone 6 mg
|
Therapy Group D
Therapy Group D Intervention: Pharmacotherapy in combination with the Integrated Psychological Therapy and Metacognitive Training will be implemented.
Monthly psychiatric treatment twice a week IPT and MCT, 60 minutes every session
The combination of the Integrated Psychological Therapy and Metacognitive Training in individuals with schizophrenia and treatment resistant schizophrenia: The combination of pharmacotherapy and psychotherapy in individuals with schizophrenia and treatment resistant schizophrenia.
Therapy period: Januar 2023-August 2023 Preevaluation: December 2022 Postevaluation: August 2023 Evaluation in follow up: March 2024
1. clozapine 300mg
2. clozapine 700mg
3. clozapine 800mg
4. clozapine 400 mg, perphenazine 8 mg, 20mg amitriptyline, amisulpride 600 mg
5. acenapine 20mg, clozapine 200mg
6. chlopromazine 500 mg, aloperidine 10 mg
7. chloropromazine 400 mg, 20 mg stelazine (triphioriopromazine)
8. Risperdal Consta 2, 50 mg, chlopromazine 200 mg
|
Therapy Group E
Therapy Group E Intervention: Pharmacotherapy in combination with the Integrated Psychological Therapy and Metacognitive Training will be implemented.
Monthly psychiatric treatment twice a week IPT and MCT, 60 minutes every session
The combination of the Integrated Psychological Therapy and Metacognitive Training in individuals with schizophrenia and treatment resistant schizophrenia: The combination of pharmacotherapy and psychotherapy in individuals with schizophrenia and treatment resistant schizophrenia.
Therapy period: Januar 2023-August 2023 Preevaluation: December 2022 Postevaluation: August 2023 Evaluation in follow up: March 2024
1. Risperdal consta 50 mg, clozapine 300 mg
2. paliperidone 9 mg, Chloropromazine 200 mg
3. aripripazole 60 mg
|
Therapy Group F
Therapy Group F Intervention: Pharmacotherapy in combination with the Integrated Psychological Therapy and Metacognitive Training will be implemented.
Monthly psychiatric treatment twice a week IPT and MCT, 60 minutes every session
The combination of the Integrated Psychological Therapy and Metacognitive Training in individuals with schizophrenia and treatment resistant schizophrenia: The combination of pharmacotherapy and psychotherapy in individuals with schizophrenia and treatment resistant schizophrenia.
Therapy period: Januar 2023-August 2023 Preevaluation: December 2022 Postevaluation: August 2023 Evaluation in follow up: March 2024
1. amisulpride 1200 mg
2. aloperidine 30 mg, clozapine 200 mg
3. amisulpride 800 mg
|
Therapy Group G
Therapy Group G Intervention: Pharmacotherapy in combination with the Integrated Psychological Therapy and Metacognitive Training will be implemented Monthly psychiatric treatment twice a week IPT and MCT, 60 minutes every session
The combination of the Integrated Psychological Therapy and Metacognitive Training in individuals with schizophrenia and treatment resistant schizophrenia: The combination of pharmacotherapy and psychotherapy in individuals with schizophrenia and treatment resistant schizophrenia.
Therapy period: Januar 2023-August 2023 Preevaluation: December 2022 Postevaluation: August 2023 Evaluation in follow up: March 2024
1. Risperidone 12 mg, akineton 4 mg
2. clozapine 350 mg
3. clozapine 400 mg
|
Therapy Group H
Therapy Group H Intervention: Pharmacotherapy in combination with the Integrated Psychological Therapy and Metacognitive Training will be implemented.
Monthly psychiatric treatment twice a week IPT and MCT, 60 minutes every session
The combination of the Integrated Psychological Therapy and Metacognitive Training in individuals with schizophrenia and treatment resistant schizophrenia: The combination of pharmacotherapy and psychotherapy in individuals with schizophrenia and treatment resistant schizophrenia.
Therapy period: Januar 2023-August 2023 Preevaluation: December 2022 Postevaluation: August 2023 Evaluation in follow up: March 2024
1. clozapine 600 mg
2. clozapine 600 mg
3. clozapine 750 mg
|
|---|---|---|---|---|---|---|---|---|
|
T1-T2 (11-2022-6 2023, 1 2023- 8 2023)
STARTED
|
5
|
2
|
8
|
8
|
3
|
3
|
3
|
3
|
|
T1-T2 (11-2022-6 2023, 1 2023- 8 2023)
COMPLETED
|
4
|
2
|
8
|
8
|
3
|
3
|
3
|
3
|
|
T1-T2 (11-2022-6 2023, 1 2023- 8 2023)
NOT COMPLETED
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
T1-T3 (11-2022-1-2024; 1 2023-3 2024)
STARTED
|
5
|
2
|
8
|
8
|
3
|
3
|
3
|
3
|
|
T1-T3 (11-2022-1-2024; 1 2023-3 2024)
COMPLETED
|
4
|
2
|
7
|
7
|
3
|
3
|
3
|
3
|
|
T1-T3 (11-2022-1-2024; 1 2023-3 2024)
NOT COMPLETED
|
1
|
0
|
1
|
1
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Therapy Group A
Therapy Group A Intervention: Pharmacotherapy in combination with the Integrated Psychological Therapy and Metacognitive Training will be implemented.
Monthly psychiatric treatment twice a week IPT and MCT, 60 minutes every session
1. clozapine 350mg, amisulpride 200mg, mirtazapine 30 mg, clonazepam 2 mg
2. olanzapine 22, 5 mg, alprazolami 0, 50 mg
3. clozapine 200mg, 400 mg amisulpride, citalopram 20 mg, clonazepam 2 mg
4. clozapine 300 mg, amisulpride 400mg
5. 250mg clozapine, cariprazime 4, 5mg
The combination of the Integrated Psychological Therapy and Metacognitive Training in individuals with schizophrenia and treatment resistant schizophrenia: The combination of pharmacotherapy and psychotherapy in individuals with schizophrenia and treatment resistant schizophrenia.
Therapy period: November 2022-June 2023 Preevaluation: 1 November 2022 Postevaluation: June 2023 Follow up evaluation Januar 2024
|
Therapy Group B
Therapy Group B Intervention: Pharmacotherapy in combination with the Integrated Psychological Therapy and Metacognitive Training will be implemented.
Monthly psychiatric treatment twice a week IPT and MCT, 60 minutes every session
The combination of the Integrated Psychological Therapy and Metacognitive Training in individuals with schizophrenia and treatment resistant schizophrenia: The combination of pharmacotherapy and psychotherapy in individuals with schizophrenia and treatment resistant schizophrenia.
Therapy period: November 2022-June 2023 Preevaluation: 1 November 2022 Postevaluation: June 2023 Follow up evaluation Januar 2024
1. olanzapine 10 mg
2. clozapine 350 mg, alprazolami 0, 5mg
|
Therapy Group C
Therapy Group C Intervention: Pharmacotherapy in combination with the Integrated Psychological Therapy and Metacognitive Training will be implemented.
Monthly psychiatric treatment twice a week IPT and MCT, 60 minutes every session
The combination of the Integrated Psychological Therapy and Metacognitive Training in individuals with schizophrenia and treatment resistant schizophrenia: The combination of pharmacotherapy and psychotherapy in individuals with schizophrenia and treatment resistant schizophrenia.
Therapy period: November 2022-June 2023 Preevaluation: 1 November 2022 Postevaluation: June 2023 Follow up evaluation Januar 2024
1. Clozapine 250 mg, aripiprazole 10 mg, alprazolam 0.5 mg
2. olanzapine 30 mg, amisulpride 400 mg
3. perphenazine 16 mg, olanzapine 10 mg, amitriptyline 40 mg
4. perphenazine 12 mg, amitriptyline 30 mg, olanzapine 15 mg
5. aripripazole depot 400 mg, zypahera 405 mg depot
6. 2 aripripazole depot 400mg (800)
7. clozapine 400 mg, valproide natrio 1000 mg, stelazine 15 mg
8. clozapine 300 mg, risperidone 6 mg
|
Therapy Group D
Therapy Group D Intervention: Pharmacotherapy in combination with the Integrated Psychological Therapy and Metacognitive Training will be implemented.
Monthly psychiatric treatment twice a week IPT and MCT, 60 minutes every session
The combination of the Integrated Psychological Therapy and Metacognitive Training in individuals with schizophrenia and treatment resistant schizophrenia: The combination of pharmacotherapy and psychotherapy in individuals with schizophrenia and treatment resistant schizophrenia.
Therapy period: Januar 2023-August 2023 Preevaluation: December 2022 Postevaluation: August 2023 Evaluation in follow up: March 2024
1. clozapine 300mg
2. clozapine 700mg
3. clozapine 800mg
4. clozapine 400 mg, perphenazine 8 mg, 20mg amitriptyline, amisulpride 600 mg
5. acenapine 20mg, clozapine 200mg
6. chlopromazine 500 mg, aloperidine 10 mg
7. chloropromazine 400 mg, 20 mg stelazine (triphioriopromazine)
8. Risperdal Consta 2, 50 mg, chlopromazine 200 mg
|
Therapy Group E
Therapy Group E Intervention: Pharmacotherapy in combination with the Integrated Psychological Therapy and Metacognitive Training will be implemented.
Monthly psychiatric treatment twice a week IPT and MCT, 60 minutes every session
The combination of the Integrated Psychological Therapy and Metacognitive Training in individuals with schizophrenia and treatment resistant schizophrenia: The combination of pharmacotherapy and psychotherapy in individuals with schizophrenia and treatment resistant schizophrenia.
Therapy period: Januar 2023-August 2023 Preevaluation: December 2022 Postevaluation: August 2023 Evaluation in follow up: March 2024
1. Risperdal consta 50 mg, clozapine 300 mg
2. paliperidone 9 mg, Chloropromazine 200 mg
3. aripripazole 60 mg
|
Therapy Group F
Therapy Group F Intervention: Pharmacotherapy in combination with the Integrated Psychological Therapy and Metacognitive Training will be implemented.
Monthly psychiatric treatment twice a week IPT and MCT, 60 minutes every session
The combination of the Integrated Psychological Therapy and Metacognitive Training in individuals with schizophrenia and treatment resistant schizophrenia: The combination of pharmacotherapy and psychotherapy in individuals with schizophrenia and treatment resistant schizophrenia.
Therapy period: Januar 2023-August 2023 Preevaluation: December 2022 Postevaluation: August 2023 Evaluation in follow up: March 2024
1. amisulpride 1200 mg
2. aloperidine 30 mg, clozapine 200 mg
3. amisulpride 800 mg
|
Therapy Group G
Therapy Group G Intervention: Pharmacotherapy in combination with the Integrated Psychological Therapy and Metacognitive Training will be implemented Monthly psychiatric treatment twice a week IPT and MCT, 60 minutes every session
The combination of the Integrated Psychological Therapy and Metacognitive Training in individuals with schizophrenia and treatment resistant schizophrenia: The combination of pharmacotherapy and psychotherapy in individuals with schizophrenia and treatment resistant schizophrenia.
Therapy period: Januar 2023-August 2023 Preevaluation: December 2022 Postevaluation: August 2023 Evaluation in follow up: March 2024
1. Risperidone 12 mg, akineton 4 mg
2. clozapine 350 mg
3. clozapine 400 mg
|
Therapy Group H
Therapy Group H Intervention: Pharmacotherapy in combination with the Integrated Psychological Therapy and Metacognitive Training will be implemented.
Monthly psychiatric treatment twice a week IPT and MCT, 60 minutes every session
The combination of the Integrated Psychological Therapy and Metacognitive Training in individuals with schizophrenia and treatment resistant schizophrenia: The combination of pharmacotherapy and psychotherapy in individuals with schizophrenia and treatment resistant schizophrenia.
Therapy period: Januar 2023-August 2023 Preevaluation: December 2022 Postevaluation: August 2023 Evaluation in follow up: March 2024
1. clozapine 600 mg
2. clozapine 600 mg
3. clozapine 750 mg
|
|---|---|---|---|---|---|---|---|---|
|
T1-T2 (11-2022-6 2023, 1 2023- 8 2023)
Anxiety
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
T1-T3 (11-2022-1-2024; 1 2023-3 2024)
Anxiety
|
1
|
0
|
1
|
1
|
0
|
0
|
0
|
0
|
Baseline Characteristics
The Effectiveness and Efficacy of the Combination of the Integrated Psychological Therapy and Metacognitive Training.
Baseline characteristics by cohort
| Measure |
Therapy Group All Participants (Groups A, B, C, D, E, F, G, H)
n=35 Participants
Pharmacotherapy in combination with the Integrated Psychological Therapy and Metacognitive Training will be implemented.
35 individuals with schizophrenia
The combination of the Integrated Psychological Therapy and Metacognitive Training in individuals with schizophrenia and treatment resistant schizophrenia: The combination of pharmacotherapy and psychotherapy in individuals with schizophrenia and treatment resistant schizophrenia.
The Groups A, B, C, D, E, F, G, H have been added to one group. They receive the same intervention.
|
|---|---|
|
Age, Customized
|
31.02 Years
STANDARD_DEVIATION 4.04 • n=5 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
|
35 Greek patients
n=5 Participants
|
|
Region of Enrollment
Greece
|
35 participants
n=5 Participants
|
|
WAIS, IQ
|
86.17 Units on a scale
STANDARD_DEVIATION 3.92 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline T1 (preintervention)-follow-up T3 (after 6 months, up to 55 weeks)Population: All participants in T1, T3. All participants participate in the same therapy
Greek verbal memory test: (verbal memory semantic condition (average) (minimum 0-maximum 40) (high scores better outcomes) MCCB: (Neuropsychological Assessment Battery) (NAB) (reasoning and problem solving): (minimum 0 maximum 26) (high scores better outcomes) Data is analyzed through SPS 13.
Outcome measures
| Measure |
Therapy Group All Participants
n=35 Participants
The combination of the Integrated Psychological Therapy and Metacognitive Training in individuals with schizophrenia and treatment resistant schizophrenia: The combination of pharmacotherapy and psychotherapy in individuals with schizophrenia and treatment resistant schizophrenia.
Therapy period: November 2022-March 2024 Preevaluation: 1 November 2022 35 participants
35 participants
|
|---|---|
|
Cognitive Functions: Matrics Consensus Cognitive Battery (MCCB), Greek Verbal Test
Verbal memory T1
|
12.09 score on a scale
Standard Deviation 1.28
|
|
Cognitive Functions: Matrics Consensus Cognitive Battery (MCCB), Greek Verbal Test
Verbal memory T3
|
19.04 score on a scale
Standard Deviation 1.70
|
|
Cognitive Functions: Matrics Consensus Cognitive Battery (MCCB), Greek Verbal Test
Problem-solving (NAB) T1
|
7.71 score on a scale
Standard Deviation 1.80
|
|
Cognitive Functions: Matrics Consensus Cognitive Battery (MCCB), Greek Verbal Test
Problem-solving (NAB) T3
|
14.00 score on a scale
Standard Deviation 2.12
|
PRIMARY outcome
Timeframe: Baseline T1 (preintervention)-follow-up T3 (after 6 months, up to 55 weeks)Population: Evaluation of T1, T3. All participants participate in the same therapy
(PANSS) Greek Version Positive symptoms (minimum 8 maximum 49) low scores better outcomes Negative symptoms: (minimum 8 maximum 49) low scores better outcomes General Psychopathology: (minimum 17 maximum 112) low scores better outcomes Total: Sum of positive, negative and general symptoms (minimum 31, maximum 210), low scores better outcomes The total score is used in the statistical analysis (PSYRAT) Auditory hallucinations (minimum 0 maximum 44) low scores better Delusion (minimum 0 maximum 24) low scores better Data is analyzed with SPSS 13
Outcome measures
| Measure |
Therapy Group All Participants
n=35 Participants
The combination of the Integrated Psychological Therapy and Metacognitive Training in individuals with schizophrenia and treatment resistant schizophrenia: The combination of pharmacotherapy and psychotherapy in individuals with schizophrenia and treatment resistant schizophrenia.
Therapy period: November 2022-March 2024 Preevaluation: 1 November 2022 35 participants
35 participants
|
|---|---|
|
Symptoms, PANSS Greek Version
PANSStotal T1
|
113.62 score on a scale
Standard Deviation 15.49
|
|
Symptoms, PANSS Greek Version
PANSStotal T3
|
70.18 score on a scale
Standard Deviation 7.67
|
PRIMARY outcome
Timeframe: Baseline T1 (preintervention)-follow-up T3 (after 6 months, up to 55 weeks)Population: All participants in T1, T3. All participants participate in the same therapy.
WHO DAS 2.0 WHODAS total: (functional outcome) (minimum 0-maximum 100) low scores better outcomes Data are analyzed with SPSS 13
Outcome measures
| Measure |
Therapy Group All Participants
n=35 Participants
The combination of the Integrated Psychological Therapy and Metacognitive Training in individuals with schizophrenia and treatment resistant schizophrenia: The combination of pharmacotherapy and psychotherapy in individuals with schizophrenia and treatment resistant schizophrenia.
Therapy period: November 2022-March 2024 Preevaluation: 1 November 2022 35 participants
35 participants
|
|---|---|
|
Functional Outcome
WHODAStotal T1
|
33.47 score on a scale
Standard Deviation 24.55
|
|
Functional Outcome
WHODAStotal T3
|
30.49 score on a scale
Standard Deviation 6.78
|
PRIMARY outcome
Timeframe: Baseline T1 (preintervention)-follow-up T3 (after 6 months, up to 55 weeks)Population: All participants in T1, T3. All participants participate in the same therapy.
RAS-DS scale Total score (sum of the scores) (0-152) high scores are better outcomes Data is analyzed through SPSS 13
Outcome measures
| Measure |
Therapy Group All Participants
n=35 Participants
The combination of the Integrated Psychological Therapy and Metacognitive Training in individuals with schizophrenia and treatment resistant schizophrenia: The combination of pharmacotherapy and psychotherapy in individuals with schizophrenia and treatment resistant schizophrenia.
Therapy period: November 2022-March 2024 Preevaluation: 1 November 2022 35 participants
35 participants
|
|---|---|
|
Recovery
RECOVERY total T1
|
90.62 score on a scale
Standard Deviation 16.49
|
|
Recovery
RCOVERY total T3
|
125.56 score on a scale
Standard Deviation 10.12
|
SECONDARY outcome
Timeframe: Baseline T1 (preintervention)Population: Pre-intervention
Intelligence, high scores are better Data is analyzed through SPSS 13.
Outcome measures
| Measure |
Therapy Group All Participants
n=35 Participants
The combination of the Integrated Psychological Therapy and Metacognitive Training in individuals with schizophrenia and treatment resistant schizophrenia: The combination of pharmacotherapy and psychotherapy in individuals with schizophrenia and treatment resistant schizophrenia.
Therapy period: November 2022-March 2024 Preevaluation: 1 November 2022 35 participants
35 participants
|
|---|---|
|
Intelligent Quotient
|
86.17 score on a scale IQ
Standard Deviation 3.92
|
Adverse Events
Therapy Group A
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Therapy Group B
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Therapy Group C
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Therapy Group D
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Therapy Group E
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Therapy Group F
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Therapy Group G
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Therapy Group H
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place