Skip to main content
OpenTrials
Completed

NCT Number: NCT05623228

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

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

Is it effective and efficacious?

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders Schizophrenia, Treatment-Resistant

Age range

19 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Stavroula Rakitzi

Athens, 15771, Greece

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diagnosis of schizophrenia
  • No relapse and hospitalization
  • Ambulant psychiatric treatment

Exclusion criteria

  • Other psychotic disorders
  • Relapse and hospitalization
  • Substance abuse

Treatment and study plan

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

Combination Product

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

Other names: Pharmacotherapy, rehabilitation

Primary outcomes

  1. Cognitive Functions: Matrics Consensus Cognitive Battery (MCCB), Greek Verbal Test

    Time frame: 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.

  2. Symptoms, PANSS Greek Version

    Time frame: 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

  3. Functional Outcome

    Time frame: 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

  4. Recovery

    Time frame: 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 outcomes

  1. Intelligent Quotient

    Time frame: Baseline T1 (preintervention)

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

Sponsors and collaborators

Lead sponsor

Rakitzi, Stavroula

Other

Registry information

Official study title

The Effectiveness and Efficacy of the Combination of the Integrated Psychological Therapy and Metacognitive Training in Schizophrenia and Treatment Resistant Schizophrenia. This is a Non-randomized Trial. The Therapy Lasts 60 Sessions.

Acronym: ATHSCHIZ

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Nov 21, 2022
Registry last updated
Mar 5, 2025

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.