The Effectiveness and Efficacy of the Combination of the Integrated Psychological Therapy and Metacognitive Training.

Rakitzi, Stavroula35 enrolled

Overview

The combination of the Integrated Psychological Therapy and Metacognitive Training in individuals with schizophrenia and treatment resistant schizophrenia. Is it effective and efficacious?

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Schizophrenia

Interventions

The combination of the Integrated Psychological Therapy and Metacognitive Training in individuals with schizophrenia and treatment resistant schizophreniaCOMBINATION_PRODUCT

The combination of pharmacotherapy and psychotherapy in individuals with schizophrenia and treatment resistant schizophrenia.

Eligibility

Sex: ALLMin age: 19 YearsMax age: 60 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Diagnosis of schizophrenia * No relapse and hospitalization * Ambulant psychiatric treatment Exclusion Criteria: * Other psychotic disorders * Relapse and hospitalization * Substance abuse

Locations (1)

Stavroula Rakitzi

Athens, Greece

Outcomes

Primary Outcomes

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)

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)

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)

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)

Secondary Outcomes

Intelligent Quotient

Intelligence, high scores are better Data is analyzed through SPSS 13.

Time frame: Baseline T1 (preintervention)

Data from ClinicalTrials.gov

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