Clinical trial NCT05623228: The Effectiveness and Efficacy of the Combination of the Integrated Psychological Therapy and Metacognitive Training.
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Schizophrenia
Keywords: Schizophrenia, treatment resistant schizophrenia, recovery
Lead sponsor: Rakitzi, Stavroula
Sponsor class: OTHER
First posted: 2022-11-21
Enrollment: 35
Sex: ALL
Minimum age (years): 19
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Pharmacotherapy in combination with the Integrated Psychological Therapy and Metacognitive Training will be implemented
Primary purpose: TREATMENT

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?

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Other psychotic disorders
* Relapse and hospitalization
* Substance abuse

Primary outcomes:
measure: Cognitive Functions: Matrics Consensus Cognitive Battery (MCCB), Greek Verbal Test
timeFrame: Baseline T1 (preintervention)-follow-up T3 (after 6 months, up to 55 weeks)
measure: Symptoms, PANSS Greek Version
timeFrame: Baseline T1 (preintervention)-follow-up T3 (after 6 months, up to 55 weeks)
measure: Functional Outcome
timeFrame: Baseline T1 (preintervention)-follow-up T3 (after 6 months, up to 55 weeks)
measure: Recovery
timeFrame: Baseline T1 (preintervention)-follow-up T3 (after 6 months, up to 55 weeks)
Secondary outcomes:
measure: Intelligent Quotient
timeFrame: Baseline T1 (preintervention)
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Stavroula Rakitzi
Study officials:
affiliation: Private Practice
name: Stavroula Rakitzi, Dr.
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Nuecterlein, K. H., & Green, M. F. (2006). MCCB. MATRICS Consensus Cognitive Battery. LA: MATRICS Assessment Inc.
citation: 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.
citation: Kosmidou, M., & Vlahou, C. (2010). Greek verbal memory test. Athens: Parisianos.
citation: Lykouras, L., Botsis, A., & Oulis, P. (2005). Greek version of PANSS. Athens: Scientific publications.
citation: 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.
citation: 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.
citation: 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.
citation: Aster, M., Neubauer, M., & Horn, R. (2006). Wechsler-Intelligenztest für Erwachsene WIE. Frankfurt: Harcourt Test Services