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

Study at a glance

From the registry record, last updated by the sponsor on 5 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official 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.

ClinicalTrials.gov ID

NCT05623228

Acronym / sponsor ID

ATHSCHIZ / (2022-2024)

Conditions

Schizophrenia

Keywords

Schizophrenia, treatment resistant schizophrenia, recovery

Phase

Phase 2

Study type

Interventional

Recruitment status

Completed

Enrolment

35 participants (actual)

Lead sponsor

Rakitzi, StavroulaUniversity, hospital or other

Study start

1 Nov 2022 (actual)

Primary completion

26 Mar 2024 (actual)

Study completion

26 Mar 2024 (actual)

First posted

21 Nov 2022 (actual)

Results

Posted 5 Mar 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose

Treatment

Allocation

Non-randomised

Intervention model

Single group

Masking

Single blind (outcomes assessor)

Number of arms

8

Model description

Pharmacotherapy in combination with the Integrated Psychological Therapy and Metacognitive Training will be implemented

Who may qualify

Ages

19 to 60 years

Sex

All

Healthy volunteers

Not accepted

Age groups

Adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Primary outcome

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

Results and safety

Loading the posted results from ClinicalTrials.gov…

Research links

• Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2025.
• Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
• Background: PubMed 35320347Penney 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.
• BackgroundRakitzi, 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: PubMed 31385737Rakitzi 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.
• Results publication: PubMed 27280523Rakitzi 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.
• Results publicationNuecterlein, K. H., & Green, M. F. (2006). MCCB. MATRICS Consensus Cognitive Battery. LA: MATRICS Assessment Inc.
• Results publicationFuentes, 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.
• Results publicationKosmidou, M., & Vlahou, C. (2010). Greek verbal memory test. Athens: Parisianos.
• Results publicationLykouras, L., Botsis, A., & Oulis, P. (2005). Greek version of PANSS. Athens: Scientific publications.
• Results publication: PubMed 10473315Haddock 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.
• Results publicationHancock, N., Scanlan, J.N., Bundy, A.C., & Honey A. (2019). Recovery Assessment Scale -Domains & Stages (RAS-DS) Manual- Version 3. Sydney: University of Sydney.
• Results publicationKoumpouros, 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.
• Results publicationAster, M., Neubauer, M., & Horn, R. (2006). Wechsler-Intelligenztest für Erwachsene WIE. Frankfurt: Harcourt Test Services
• linkedin Stavroula RakitziLink provided by the sponsor.
• orcid: 0000-0002-5231-6619Link provided by the sponsor.
• Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

1 site in 1 country: see every site and its status.