Schizophrenia
Conditions
Keywords
Schizophrenia, treatment resistant schizophrenia, recovery
Brief summary
The combination of the Integrated Psychological Therapy and Metacognitive Training in individuals with schizophrenia and treatment resistant schizophrenia. Is it effective and efficacious?
Detailed description
Individuals with schizophrenia and treatment resistant schizophrenia will participate on a group cognitive behavioral therapy and rehabilitation, in which Integrated Psychological Therapy and Metacognitive Training are going to be implemented. The therapy will last 60 biweekly sessions. This is a non randomized trial. Speed of processing, working memory, verbal memory, visual memory, reasoning and problem solving, social cognition, symptoms, functional outcome and recovery will be evaluated before, after therapy and in a 6 months follow up. MCCB, Social Perception Scale, the Greek Test for verbal memory, PANSS, WHO DAS 2. 0 (Greek), PSYRAT and the Recovery Assessment Scale will be used ih this study.
Interventions
COMBINATION_PRODUCTThe 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.
Sponsors
Rakitzi, Stavroula
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Pharmacotherapy in combination with the Integrated Psychological Therapy and Metacognitive Training will be implemented
Eligibility
Sex/Gender
ALL
Age
19 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of schizophrenia * No relapse and hospitalization * Ambulant psychiatric treatment
Exclusion criteria
* Other psychotic disorders * Relapse and hospitalization * Substance abuse
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cognitive Functions: Matrics Consensus Cognitive Battery (MCCB), Greek Verbal Test | Baseline T1 (preintervention)-follow-up T3 (after 6 months, up to 55 weeks) | 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. |
| Symptoms, PANSS Greek Version | Baseline T1 (preintervention)-follow-up T3 (after 6 months, up to 55 weeks) | (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 |
| Functional Outcome | Baseline T1 (preintervention)-follow-up T3 (after 6 months, up to 55 weeks) | WHO DAS 2.0 WHODAS total: (functional outcome) (minimum 0-maximum 100) low scores better outcomes Data are analyzed with SPSS 13 |
| Recovery | Baseline T1 (preintervention)-follow-up T3 (after 6 months, up to 55 weeks) | RAS-DS scale Total score (sum of the scores) (0-152) high scores are better outcomes Data is analyzed through SPSS 13 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intelligent Quotient | Baseline T1 (preintervention) | Intelligence, high scores are better Data is analyzed through SPSS 13. |
Countries
Greece
Participant flow
Recruitment details
November 2022-Januar 2023 Patients were recruited from our private practice Dr. Stavroula Rakitzi Dr. Polyxeni Georgila
Pre-assignment details
35 patients with schizophrenia started
Participants by arm
| Arm | Count |
|---|---|
| Therapy Group All Participants (Groups A, B, C, D, E, F, G, H) 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. | 35 |
| Total | 35 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 |
|---|---|---|---|---|---|---|---|---|---|
| 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
| Characteristic | Therapy Group All Participants (Groups A, B, C, D, E, F, G, H) |
|---|---|
| Age, Customized | 31.02 Years STANDARD_DEVIATION 4.04 |
| Race/Ethnicity, Customized | 35 Greek patients |
| Region of Enrollment Greece | 35 participants |
| Sex: Female, Male Female | 21 Participants |
| Sex: Female, Male Male | 14 Participants |
| WAIS, IQ | 86.17 Units on a scale STANDARD_DEVIATION 3.92 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk |
|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 5 | 0 / 2 | 0 / 8 | 0 / 8 | 0 / 3 | 0 / 3 | 0 / 3 | 0 / 3 |
| other Total, other adverse events | 0 / 5 | 0 / 2 | 0 / 8 | 0 / 8 | 0 / 3 | 0 / 3 | 0 / 3 | 0 / 3 |
| serious Total, serious adverse events | 0 / 5 | 0 / 2 | 0 / 8 | 0 / 8 | 0 / 3 | 0 / 3 | 0 / 3 | 0 / 3 |
Outcome results
Primary
Cognitive Functions: Matrics Consensus Cognitive Battery (MCCB), Greek Verbal Test
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.
Time frame: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Therapy Group All Participants | Cognitive Functions: Matrics Consensus Cognitive Battery (MCCB), Greek Verbal Test | Verbal memory T1 | 12.09 score on a scale | Standard Deviation 1.28 |
| Therapy Group All Participants | Cognitive Functions: Matrics Consensus Cognitive Battery (MCCB), Greek Verbal Test | Verbal memory T3 | 19.04 score on a scale | Standard Deviation 1.7 |
| Therapy Group All Participants | Cognitive Functions: Matrics Consensus Cognitive Battery (MCCB), Greek Verbal Test | Problem-solving (NAB) T1 | 7.71 score on a scale | Standard Deviation 1.8 |
| Therapy Group All Participants | Cognitive Functions: Matrics Consensus Cognitive Battery (MCCB), Greek Verbal Test | Problem-solving (NAB) T3 | 14.00 score on a scale | Standard Deviation 2.12 |
p-value: 0ANOVA
p-value: 0ANOVA
Primary
Functional Outcome
WHO DAS 2.0 WHODAS total: (functional outcome) (minimum 0-maximum 100) low scores better outcomes Data are analyzed with SPSS 13
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Therapy Group All Participants | Functional Outcome | WHODAStotal T1 | 33.47 score on a scale | Standard Deviation 24.55 |
| Therapy Group All Participants | Functional Outcome | WHODAStotal T3 | 30.49 score on a scale | Standard Deviation 6.78 |
p-value: 0ANOVA
Primary
Recovery
RAS-DS scale Total score (sum of the scores) (0-152) high scores are better outcomes Data is analyzed through SPSS 13
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Therapy Group All Participants | Recovery | RECOVERY total T1 | 90.62 score on a scale | Standard Deviation 16.49 |
| Therapy Group All Participants | Recovery | RCOVERY total T3 | 125.56 score on a scale | Standard Deviation 10.12 |
p-value: 0.04ANOVA
Primary
Symptoms, PANSS Greek Version
(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
Time frame: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Therapy Group All Participants | Symptoms, PANSS Greek Version | PANSStotal T1 | 113.62 score on a scale | Standard Deviation 15.49 |
| Therapy Group All Participants | Symptoms, PANSS Greek Version | PANSStotal T3 | 70.18 score on a scale | Standard Deviation 7.67 |
p-value: 0.04ANOVA
Secondary
Intelligent Quotient
Intelligence, high scores are better Data is analyzed through SPSS 13.
Time frame: Baseline T1 (preintervention)
Population: Pre-intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Therapy Group All Participants | Intelligent Quotient | 86.17 score on a scale IQ | Standard Deviation 3.92 |
p-value: 0t-test, 1 sided