CClinicalTrials.gg
Sign In
CompletedNCT05623228ATHSCHIZUpdated Mar 5, 2025Results posted

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

A Phase 2 interventional study of The combination of the Integrated Psychological Therapy and Metacognitive Training in individuals with schizophrenia and treatment resistant schizophrenia in Schizophrenia, sponsored by Rakitzi, Stavroula. Completed at 1 site in Greece. Open to participants aged 19 Years to 60 Years. Per ClinicalTrials.gov, last updated 2025-03-05.

Sponsored by Rakitzi, Stavroula · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
35
Allocation
Non-randomized
Ages
19 Years to 60 Years
Sex
All
01

Study summary

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

Is it effective and efficacious?

Read the 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.

02

Conditions studied

  • Schizophrenia

Keywords

  • Schizophrenia, treatment resistant schizophrenia, recovery
03

In context

Schizophrenia

3,471 studies on the registry are indexed under Schizophrenia; 472 are open to participants now.

This study's enrollment of 35 is below the median of 70 across 2,872 interventional studies indexed under Schizophrenia.

Browse Schizophrenia studies →

Lead sponsor

Rakitzi, Stavroula is the lead sponsor of 3 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Other psychotic disorders
  • Relapse and hospitalization
  • Substance abuse
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
Single (Outcomes assessor)
Enrollment
35 participants (actual)

Study arms

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

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.

    Also known as: Pharmacotherapy, rehabilitation

06

What researchers measure

Primary outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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

  1. Intelligent Quotient

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

    Time frame: Baseline T1 (preintervention)

07

Results

Posted Mar 5, 2025
Limitations and caveats
No limitations

Participant flow

November 2022-Januar 2023 Patients were recruited from our private practice Dr. Stavroula Rakitzi Dr. Polyxeni Georgila

T1-T2 (11-2022-6 2023, 1 2023- 8 2023)
Participant flow — T1-T2 (11-2022-6 2023, 1 2023- 8 2023)
MilestoneTherapy Group ATherapy Group BTherapy Group CTherapy Group DTherapy Group ETherapy Group FTherapy Group GTherapy Group H
Started52883333
Completed42883333
Not completed10000000
Withdrew: Anxiety10000000
T1-T3 (11-2022-1-2024; 1 2023-3 2024)
Participant flow — T1-T3 (11-2022-1-2024; 1 2023-3 2024)
MilestoneTherapy Group ATherapy Group BTherapy Group CTherapy Group DTherapy Group ETherapy Group FTherapy Group GTherapy Group H
Started52883333
Completed42773333
Not completed10110000
Withdrew: Anxiety10110000

Outcome measures

PrimaryCognitive 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)
Reported as:
Mean · score on a scale
Cognitive Functions: Matrics Consensus Cognitive Battery (MCCB), Greek Verbal Test
score on a scaleTherapy Group All Participants
Verbal memory T112.09 ± 1.28
Verbal memory T319.04 ± 1.70
Problem-solving (NAB) T17.71 ± 1.80
Problem-solving (NAB) T314.00 ± 2.12
Statistical analysis
  • Therapy Group All Participants · ANOVA · p = .00 (Bonferroni correction p\<.05 F(1.25)=9.17 η=.254 (p\<.05))
  • Therapy Group All Participants · ANOVA · p = .00 (Bonferroni correction p\<.05 F(2)=7.30 η=.213 (P\<.05))
PrimarySymptoms, 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)
Reported as:
Mean · score on a scale
Symptoms, PANSS Greek Version
score on a scaleTherapy Group All Participants
PANSStotal T1113.62 ± 15.49
PANSStotal T370.18 ± 7.67
Statistical analysis
  • Therapy Group All Participants · ANOVA · p = .04 (F(2)=3.20, η=.106 Bonferroni Correction p\<.05)
PrimaryFunctional 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)
Reported as:
Mean · score on a scale
Functional Outcome
score on a scaleTherapy Group All Participants
WHODAStotal T133.47 ± 24.55
WHODAStotal T330.49 ± 6.78
Statistical analysis
  • Therapy Group All Participants · ANOVA · p = .00 (F(1,06)=8,11, η2=.231 Bonferroni correction p\<.05)
PrimaryRecovery

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)
Reported as:
Mean · score on a scale
Recovery
score on a scaleTherapy Group All Participants
RECOVERY total T190.62 ± 16.49
RCOVERY total T3125.56 ± 10.12
Statistical analysis
  • Therapy Group All Participants · ANOVA · p = .04 (F(1,19)=4,30, η2=.137 Bonferroni correction p\<0.5)
SecondaryIntelligent Quotient

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

Time frame:
Baseline T1 (preintervention)
Reported as:
Mean · score on a scale IQ
Intelligent Quotient
score on a scale IQTherapy Group All Participants
Intelligent Quotient86.17 ± 3.92
Statistical analysis
  • Therapy Group All Participants · t-test, 1 sided · p = .00 (t (38.70))

Adverse events

Collected over November 2022-March 2024. Adverse events were evaluated monthly, from Novemeber 2022-March 2024, for every participant.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Therapy Group A0/5 (0%)0/5 (0%)0/5 (0%)
Therapy Group B0/2 (0%)0/2 (0%)0/2 (0%)
Therapy Group C0/8 (0%)0/8 (0%)0/8 (0%)
Therapy Group D0/8 (0%)0/8 (0%)0/8 (0%)
Therapy Group E0/3 (0%)0/3 (0%)0/3 (0%)
Therapy Group F0/3 (0%)0/3 (0%)0/3 (0%)
Therapy Group G0/3 (0%)0/3 (0%)0/3 (0%)
Therapy Group H0/3 (0%)0/3 (0%)0/3 (0%)

Baseline characteristics

Age, Customized
Age, Customized(Years)Therapy Group All Participants (Groups A, B, C, D, E, F, G, H)
Mean31.02 ± 4.04
Sex: Female, Male
Sex: Female, Male(Participants)Therapy Group All Participants (Groups A, B, C, D, E, F, G, H)
Female21
Male14
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Greek patients)Therapy Group All Participants (Groups A, B, C, D, E, F, G, H)
Number35
Region of Enrollment
Region of Enrollment(participants)Therapy Group All Participants (Groups A, B, C, D, E, F, G, H)
Greece35
WAIS, IQ
WAIS, IQ(Units on a scale)Therapy Group All Participants (Groups A, B, C, D, E, F, G, H)
Mean86.17 ± 3.92
08

Study locations

1 site
  • Stavroula Rakitzi
    Athens, 15771, Greece
09

References and documents

Publications

  • 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. PubMed 35320347 ↗
  • 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.
  • 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. PubMed 31385737 ↗
  • 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. PubMed 27280523 ↗
  • Nuecterlein, K. H., & Green, M. F. (2006). MCCB. MATRICS Consensus Cognitive Battery. LA: MATRICS Assessment Inc.
  • 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.
  • Kosmidou, M., & Vlahou, C. (2010). Greek verbal memory test. Athens: Parisianos.
  • Lykouras, L., Botsis, A., & Oulis, P. (2005). Greek version of PANSS. Athens: Scientific publications.
  • 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. PubMed 10473315 ↗
  • 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.
  • 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.
  • Aster, M., Neubauer, M., & Horn, R. (2006). Wechsler-Intelligenztest für Erwachsene WIE. Frankfurt: Harcourt Test Services

Study documents

  • Protocol and statistical analysis plan · Nov 15, 2024
  • Informed consent form · Nov 15, 2024

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 5, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT05623228
Lead sponsor
Rakitzi, Stavroula
Responsible party
Sponsor
First posted
Nov 21, 2022
Start date
Nov 1, 2022
Primary completion
Mar 26, 2024
Completion
Mar 26, 2024
Results posted
Mar 5, 2025
Last update
Mar 5, 2025

Study contacts

Stavroula Rakitzi, Dr.
study director · Private Practice

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Schizophrenia→

Other studies from this sponsor

Rakitzi, Stavroula

Start the discussion