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

April 15, 2024 updated by: Rakitzi, Stavroula

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.

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

Is it effective and efficacious?

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

35

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Greece
      • Athens, Greece, 15771
        • Stavroula Rakitzi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Other psychotic disorders
  • Relapse and hospitalization
  • Substance abuse

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Therapy Group A

Therapy Group A Intervention: Pharmacotherapy in combination with the Integrated Psychological Therapy and Metacognitive Training will be implemented.

5 individuals with schizophrenia
Combination product: 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.
Other Names:
  • Pharmacotherapy, rehabilitation
Experimental: Therapy Group B

Therapy Group B Intervention: Pharmacotherapy in combination with the Integrated Psychological Therapy and Metacognitive Training will be implemented.

2 individuals with schizophrenia
Combination product: 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.
Other Names:
  • Pharmacotherapy, rehabilitation
Experimental: Therapy Group C

Therapy Group C Intervention: Pharmacotherapy in combination with the Integrated Psychological Therapy and Metacognitive Training will be implemented.

8
Combination product: 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.
Other Names:
  • Pharmacotherapy, rehabilitation
Experimental: Therapy Group D

Therapy Group D Intervention: Pharmacotherapy in combination with the Integrated Psychological Therapy and Metacognitive Training will be implemented.

8
Combination product: 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.
Other Names:
  • Pharmacotherapy, rehabilitation
Experimental: Therapy Group E

Therapy Group E Intervention: Pharmacotherapy in combination with the Integrated Psychological Therapy and Metacognitive Training will be implemented.

3
Combination product: 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.
Other Names:
  • Pharmacotherapy, rehabilitation
Experimental: Therapy Group F

Therapy Group F Intervention: Pharmacotherapy in combination with the Integrated Psychological Therapy and Metacognitive Training will be implemented.

3
Combination product: 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.
Other Names:
  • Pharmacotherapy, rehabilitation
Experimental: Therapy Group G
Therapy Group G Intervention: Pharmacotherapy in combination with the Integrated Psychological Therapy and Metacognitive Training will be implemented 3
Combination product: 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.
Other Names:
  • Pharmacotherapy, rehabilitation
Experimental: Therapy Group H

Therapy Group H Intervention: Pharmacotherapy in combination with the Integrated Psychological Therapy and Metacognitive Training will be implemented.

3
Combination product: 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.
Other Names:
  • Pharmacotherapy, rehabilitation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cognitive functions: Matrics Consensus Cognitive Battery (MCCB), SPS, Greek Verbal Test
Time Frame: 45 minutes

Speed of processing Trail making Test Part A: BACS Symbol coding: Working memory: Letter number span, Greek Verbal memory:

Visual learning: Brief Visuospatial Memory, Reasoning and problem solving: NAB Mazes, Social Cognition: Managing emotions (MSCEIT) (MCCB), Social Cognition: Social Perception Scale BACS Symbol coding: the number of the correct symbol coding in 90 seconds. (0-110). The increased score is associated with improvement Working memory: Letter number span: 0-24, the increased score is associated with improvement Rakitzi, S., 2007. The Letter Number Span in Greek. Translation. Unpublished. The LNS was translated in Greek fr
45 minutes
Symptoms
Time Frame: 40 minutes

(PANSS): Lykouras, L., Botsis, A., & Ulis, P. (2005). PANSS. The Greek manual. Athens: Scientific publications. Positive symptoms 8-49, the decreased score is associated with improvement Negative symptoms: 8-49, the decreased score is associated with improvement General Psychopathology: 17-112, the decreased score is associated with improvement

(PSYRAT): Haddock, G. , McCarron, J., Tarrier, N. and Faragher, E.B. (1999) Scales to measure dimensions of hallucinations and delusions: the psychotic symptom rating scales (PSYRATS). Psychological Medicine, 29, 879-889

Dr. Stavroula Rakitzi has the permission to use this scale Each category has a score 1-4, the decreased score is associated with improvement. To generate a total score for the rating scale overall, calculate the total of all auditory hallucination items. To generate a total score for the rating scale overall, calculate the total of all delusions items.
40 minutes
Functional outcome
Time Frame: 20 minutes
WHO DAS 2.0: Koumpouros, I., Sakellari, E., Papageorgiou, E., & Lagiou, A. (2017). WHODAS 2. 0. Greek Manual Koumpouros, I., Papageorgiou, E., Sakellari, E. et al. Adaptation and psychometric properties evaluation of the Greek version of WHODAS 2.0. pilot application in Greek elderly population. Health Services and Outcomes Research Methodology, 2018, 18(1): 63-74. https://doi.org/10.1007/s10742-017-0176-x Calculation 0-100 The decreased score is associated with better functional outcome
20 minutes
Recovery
Time Frame: 10 minutes
Recovery Assessment Scale: Hancock, N., Scanlan, J.N., Bundy, A.C., & Honey, A. (2016). Recovery Assessment Scale - Domains & Stages (RAS-DS) Manual- Version 2. Sydney; University of Sydney. The scale is translated in Greek from Dr. Stavroula Rakitzi in cooperation with Prof. Hancock. The increased score is associated with improvement Total score 0-152
10 minutes

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intelligent Quotient
Time Frame: 90 minutes
WAIS: Aster Neubauer, Horn. 2006. Wechsler Intelligenz test fuer Erwachsense. Harcourt Test services
90 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rakitzi, Stavroula

Investigators

  • Study Director: Stavroula Rakitzi, Dr., Private Practice

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2022

Primary Completion (Estimated)

July 31, 2024

Study Completion (Estimated)

December 20, 2024

Study Registration Dates

First Submitted

November 4, 2022

First Submitted That Met QC Criteria

November 14, 2022

First Posted (Actual)

November 21, 2022

Study Record Updates

Last Update Posted (Actual)

April 17, 2024

Last Update Submitted That Met QC Criteria

April 15, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • (2022-2024)
  • (ATH22-24) (Other Identifier: Dr. Stavroula Rakitzi private practice)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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