NCT05623228

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?

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at below P25 for phase_2 schizophrenia

Timeline
Completed

Started Nov 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2022

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

November 4, 2022

Completed
17 days until next milestone

First Posted

Study publicly available on registry

November 21, 2022

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 26, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 26, 2024

Completed
11 months until next milestone

Results Posted

Study results publicly available

March 5, 2025

Completed
Last Updated

March 5, 2025

Status Verified

February 1, 2025

Enrollment Period

1.4 years

First QC Date

November 4, 2022

Results QC Date

October 17, 2024

Last Update Submit

February 11, 2025

Conditions

Schizophrenia

Keywords

Schizophrenia, treatment resistant schizophrenia, recovery

Outcome Measures

Primary Outcomes (4)

  • 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.

    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

    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

    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

    Baseline T1 (preintervention)-follow-up T3 (after 6 months, up to 55 weeks)

Secondary Outcomes (1)

  • Intelligent Quotient

    Baseline T1 (preintervention)

Study Arms (8)

Therapy Group A

EXPERIMENTAL

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

Therapy Group B

EXPERIMENTAL

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

Therapy Group C

EXPERIMENTAL

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

Therapy Group D

EXPERIMENTAL

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

Therapy Group E

EXPERIMENTAL

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

Therapy Group F

EXPERIMENTAL

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

Therapy Group G

EXPERIMENTAL

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

Therapy Group H

EXPERIMENTAL

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

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.

Also known as: Pharmacotherapy, rehabilitation
Therapy Group ATherapy Group BTherapy Group CTherapy Group DTherapy Group ETherapy Group FTherapy Group GTherapy Group H

Eligibility Criteria

Age19 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • Other psychotic disorders
  • Relapse and hospitalization
  • Substance abuse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stavroula Rakitzi

Athens, 15771, Greece

Location

Related Publications (12)

  • Penney D, Sauve G, Mendelson D, Thibaudeau E, Moritz S, Lepage M. Immediate and Sustained Outcomes and Moderators Associated With Metacognitive Training for Psychosis: A Systematic Review and Meta-analysis. JAMA Psychiatry. 2022 May 1;79(5):417-429. doi: 10.1001/jamapsychiatry.2022.0277.

    PMID: 35320347BACKGROUND

  • Rakitzi, S., Georgila, P., Becker-Woitag, A.P. (2021). The recovery process for individuals with schizophrenia in the context of evidence based psychotherapy and rehabilitation. A systematic review. European Psychologist, 26(2), 96-111 doi/pdf/10.1027/1016-9040/a000400.

    BACKGROUND

  • Rakitzi S, Georgila P. Integrated Psychological Therapy and Treatment-Resistant Schizophrenia: Initial Findings. Psychiatry. 2019 Winter;82(4):354-367. doi: 10.1080/00332747.2019.1616658. Epub 2019 Aug 6.

    PMID: 31385737BACKGROUND

  • Rakitzi S, Georgila P, Efthimiou K, Mueller DR. Efficacy and feasibility of the Integrated Psychological Therapy for outpatients with schizophrenia in Greece: Final results of a RCT. Psychiatry Res. 2016 Aug 30;242:137-143. doi: 10.1016/j.psychres.2016.05.039. Epub 2016 May 30.

    PMID: 27280523RESULT

  • Nuecterlein, K. H., & Green, M. F. (2006). MCCB. MATRICS Consensus Cognitive Battery. LA: MATRICS Assessment Inc.

    RESULT

  • Fuentes, I., Garcia, S., Ruiz, J.C., Soler, J., & Roder, V. (2007). Social perception scale in Schizophrenia. A pilot study. International Journal of Psychology and Psychological therapy, 7 (1), 1-12.

    RESULT

  • Kosmidou, M., & Vlahou, C. (2010). Greek verbal memory test. Athens: Parisianos.

    RESULT

  • Lykouras, L., Botsis, A., & Oulis, P. (2005). Greek version of PANSS. Athens: Scientific publications.

    RESULT

  • Haddock G, McCarron J, Tarrier N, Faragher EB. Scales to measure dimensions of hallucinations and delusions: the psychotic symptom rating scales (PSYRATS). Psychol Med. 1999 Jul;29(4):879-89. doi: 10.1017/s0033291799008661.

    PMID: 10473315RESULT

  • Hancock, N., Scanlan, J.N., Bundy, A.C., & Honey A. (2019). Recovery Assessment Scale -Domains & Stages (RAS-DS) Manual- Version 3. Sydney: University of Sydney.

    RESULT

  • Koumpouros, Y., Papageorgiou, E., Sakellari, E. et al. (2018). 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,18(1), 63-74. https://doi.org/10.1007/s10742-017-0176-x.

    RESULT

  • Aster, M., Neubauer, M., & Horn, R. (2006). Wechsler-Intelligenztest für Erwachsene WIE. Frankfurt: Harcourt Test Services

    RESULT

Related Links

MeSH Terms

Conditions

SchizophreniaSchizophrenia, Treatment-Resistant

Interventions

Drug TherapyRehabilitation

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

TherapeuticsAftercareContinuity of Patient CarePatient CareHealth ServicesHealth Care Facilities Workforce and Services

Limitations and Caveats

No limitations

Results Point of Contact

Title
Dr. Stavroula Rakitzi
Organization
Private practice
srakitzi@gmail.com
6989766935

Study Officials

  • Stavroula Rakitzi, Dr.

    Private Practice

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Pharmacotherapy in combination with the Integrated Psychological Therapy and Metacognitive Training will be implemented
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 4, 2022

First Posted

November 21, 2022

Study Start

November 1, 2022

Primary Completion

March 26, 2024

Study Completion

March 26, 2024

Last Updated

March 5, 2025

Results First Posted

March 5, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations

GR(1)