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Lo studio clinico NCT07255131 (RAKITZIHCFA) per Depression - Major Depressive Disorder, Anxiety Chronic, Ansia, Esito funzionale, Recupero, Obsessive Compulsive Disorders, Assertiveness è in arruolamento. Consulti la vista a schede del Radar degli Studi Clinici e gli strumenti di scoperta IA per tutti i dettagli. Oppure, ponga pure una domanda qui. | ||
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The Effectiveness and Efficacy of an Online Cognitive Behavioral Psychotherapeutic Program (RAKITZIHCFA)
I dettagli dello studio clinico sono disponibili principalmente in inglese. Tuttavia, Trial Radar IA può essere d'aiuto! Basta cliccare su 'Spiega lo studio' per visualizzare e discutere le informazioni sullo studio nella lingua selezionata.
La sperimentazione clinica NCT07255131 (RAKITZIHCFA) è uno studio interventistico per Depression - Major Depressive Disorder, Anxiety Chronic, Ansia, Esito funzionale, Recupero, Obsessive Compulsive Disorders, Assertiveness, attualmente in arruolamento. Avviato il 26 settembre 2025, prevede di arruolare 52 partecipanti. Sotto la guida di Rakitzi, Stavroula, dovrebbe concludersi entro il 20 dicembre 2028. I dati più recenti da ClinicalTrials.gov sono stati aggiornati l'ultima volta il 28 novembre 2025.
Sommario breve
An online group cognitive behavioral psychotherapeutic program will be offered to patients with cystic fibrosis and to caregivers by the Hellenic Cystic Fibrosis Association. These 2 above therapy groups will be compared with control groups in a randomized controlled trial
Descrizione dettagliata
A therapy group of patients with cystic fibrosis, who participate on the online group cognitive behavioral psychotherapeutic program will be compared with a control group of patients with cystic fibrosis, who participate in an online group supportive psychotherapeutic program. Both of the groups participate on 13 sessions once a week.
A therapy group of caregivers, who participate on the online group cognitive behavioral psychotherapeutic program will be compared with a control group of caregivers, who participate in an online group supportive psychotherapeutic program. Both of the groups participate on 13 sessions once a week.
Titolo ufficiale
The Effectiveness and Efficacy of an Online Group Cognitive Behavioral Psychotherapy in Patients With Cystic Fibrosis and Caregivers in Comparison to Control Groups by the Hellenic Cystic Fibrosis Association A Randomized Controlled Trial
Condizioni
Depression - Major Depressive DisorderAnxiety ChronicAnsiaEsito funzionaleRecuperoObsessive Compulsive DisordersAssertivenessPubblicazioni
Articoli scientifici e documenti di ricerca pubblicati su questo studio clinico:- Rakitzi, S., Spinou, A., & Giannaki, K. (2025). The effectiveness of an online-group cognitive behavioral psychotherapy in Hellenic Cystic Fibrosis Association for patients and caregivers. Journal of rational emotive and cognitive behavior therapy. DOI: 10.1007/s10942-025-00611-3
- Rakitzi, S. (2023). Clinical psychology and cognitive behavioral psychotherapy. Recovery in mental health. Springer.
- Mayr, S., Erdfelder, E., Buchner, A., & Faul, F. (2007). A short tutorial of G-Power. Tutorials in Quantitative Methods in Psychology, 3(2), 51-59.
- Koumpouros, Y., Papageorgiou, E., Sakellari, E., Prapas, X., Perifanou, D., & Lagiou, A. (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.
- Hofmann SG, Asnaani A, Vonk IJ, Sawyer AT, Fang A. The Efficacy of Cognitive Behavioral Therapy: A Review of Meta-analyses. Cognit Ther Res. 2012 Oct 1;36(5):427-440. doi: 10.1007/s10608-012-9476-1. Epub 2012 Jul 31.
- Hancock N, Scanlan JN, Honey A, Bundy AC, O'Shea K. Recovery Assessment Scale - Domains and Stages (RAS-DS): Its feasibility and outcome measurement capacity. Aust N Z J Psychiatry. 2015 Jul;49(7):624-33. doi: 10.1177/0004867414564084. Epub 2014 Dec 19.
- HAMILTON M. A rating scale for depression. J Neurol Neurosurg Psychiatry. 1960 Feb;23(1):56-62. doi: 10.1136/jnnp.23.1.56. No abstract available.
- Fountoulakis KN, Iacovides A, Kleanthous S, Samolis S, Gougoulias K, St Kaprinis G, Bech P. The Greek translation of the symptoms rating scale for depression and anxiety: preliminary results of the validation study. BMC Psychiatry. 2003 Dec 10;3:21. doi: 10.1186/1471-244X-3-21.
- Fiedler, P. (2005). Verhaltenstherapie in Gruppen. Beltz.
- Cohen, J. (1988). Statistical Power Analyses for the Behavioural Sciences. Erlbaum.
- Bech, P. (1993). Rating scales for Psychopathology, Health Status and Quality of Life. Springer-Verlag.
- Αntoniou, V., Εfthimiou, Κ., & Μilona, Κ.(2015). Social anxiety and assertiveness. A structured group cognitive behavioral program. IETHS.
Altri ID dello studio
- RAKITZIHCFA
- RAKITZI CYSTIC FIBROSIS
- HELLENIC CYSTIC FIBROSIS ASSOC (Altro identificativo) (HELLENIC CYSTIC FIBROSIS ASSOCIATION & DR. STAVROULA RAKITZI)
Numero NCT
Data di inizio (effettiva)
2025-09-26
Ultimo aggiornamento pubblicato
2025-11-28
Data di completamento (stimata)
2028-12-20
Arruolamento (previsto)
52
Tipo di studio
Interventistico
FASE
N.D.
Stato
In arruolamento
Parole chiave
Cystic Fibrosis
Group cognitive behavioral psychotherapy
Group cognitive behavioral psychotherapy
Scopo principale
Trattamento
Allocazione
Randomizzato
Modello di intervento
In parallelo
Mascheramento
Singolo
Bracci / Interventi
| Gruppo/Braccio di partecipanti | Intervento/Trattamento |
|---|---|
SperimentaleTherapy group A patients with Cystic Fibrosis Participation on an online group cognitive behavioral psychotherapy via Zoom in 13 sessions. | Group a an Online Group Cognitive Behavioral Psychotherapy in 13 Sessions Via Zoom An online group cognitive behavioral psychotherapy will be offered via Zoom in 13 sessions to the therapy Group A, to patients with cystic fibrosis |
Comparatore attivoControl group B Patients with cystic fibrosis Participation on an online group supportive psychotherapy via Zoom in 13 sessions. | Group B an Online Group Supportive Psychotherapy in 13 Sessions Via Zoom An online group supportive psychotherapy will be offered via Zoom in 13 sessions to the control group Group B, to patients with cystic fibrosis |
SperimentaleTherapy group C caregivers of patients with cystic fibrosis Participation on an online group cognitive behavioral psychotherapy via Zoom in 13 sessions. | Group C an Online Group Cognitive Behavioral Psychotherapy in 13 Sessions Via Zoom An online group cognitive behavioral psychotherapy will be offered via Zoom in 13 sessions to the therapy group C, to caregivers of patients with cystic fibrosis |
Comparatore attivoContol group D caregivers of patients with cystic fibrosis Participation on an online group supportive psychotherapy via Zoom in 13 sessions. | Group D an Online Group Supportive Psychotherapy in 13 Sessions Via Zoom An online group supportive psychotherapy will be offered via Zoom in 13 sessions to the control Group D, to caregivers of patients with cystic fibrosis |
Esito primario
| Misure di esito | Descrizione della misura | Arco temporale |
|---|---|---|
SCL-90-R | It evaluates psychopathology. T\>60 means psychopathology. Low scores better | Preintervention |
SCL-90-R | It evaluates psychopathology. T\>60 means psychopathology. Low scores better | Immediately after the intervention |
SCL-90-R | It evaluates psychopathology. T\>60 means psychopathology. Low scores better | Follow-up up to 24 weeks |
SRSDA | It measures Depression. Minimum 0 Maximum over 14. Low scores better | Preintervention |
SRSDA | It measures Depression. Minimum 0 Maximum over 14. Low scores better | Immediately after intervention |
SRSDA | It measures Depression. Minimum 0 Maximum over 14. Low scores better | Follow-up up to 24 weeks |
SRSDA | It measures anxiety. Minimum 0 Maximum over 10. Low scores better | Preintervention |
SRSDA | It measures anxiety. Minimum 0 Maximum over 10. Low scores better | Immediately after intervention |
SRSDA | It measures anxiety. Minimum 0 Maximum over 10. Low scores better | Follow-up up to 24 weeks |
U Uncertainty questionnaire | It evaluates social skills and assertiveness.: fear of criticism (psychopathology in \>35), fear of contact (psychopathology in \>41) , assertiveness (psychopathology in \<26) , difficulty of saying no (psychopathology in \>28) , guilt and decency (psychopathology in \>9) | Preintervention |
U Uncertainty questionnaire | It evaluates social skills and assertiveness.: fear of criticism (psychopathology in \>35), fear of contact (psychopathology in \>41) , assertiveness (psychopathology in \<26) , difficulty of saying no (psychopathology in \>28) , guilt and decency (psychopathology in \>9) | Immediately after the intervention |
U Uncertainty questionnaire | It evaluates social skills and assertiveness.: fear of criticism (psychopathology in \>35), fear of contact (psychopathology in \>41) , assertiveness (psychopathology in \<26) , difficulty of saying no (psychopathology in \>28) , guilt and decency (psychopathology in \>9) | Follow up up to 24 weeks |
Hamilton Depression Scale | It measures depression. Minimum 0, maximum 23. Low scores better. | Preintervention |
Hamilton Depression Scale | It measures depression. Minimum 0, maximum 23. Low scores better. | Immediately after the intervention |
Hamilton Depression Scale | It measures depression. Minimum 0, maximum 23. Low scores better. | Follow up up to 24 weeks |
WHODAS total | It measures functional outcome. Minimum 0, maximum 100. low scores better. | Preintervention |
WHODAS total | It measures functional outcome. Minimum 0, maximum 100. low scores better. | Immediately after the intervention |
WHODAS total | It measures functional outcome. Minimum 0, maximum 100. low scores better. | Follow up up to 24 weeks |
RAS-DS total | Recovery. It measures recovery. Minimum 0, maximum 152. High scores better. | Preintervention |
RAS-DS total | Recovery. It measures recovery. Minimum 0, maximum 152. High scores better. | Immediately after intervention |
RAS-DS total | Recovery. It measures recovery. Minimum 0, maximum 152. High scores better. | Follow up up to 24 weeks |
Criteri di eleggibilità
Età idonea
Adulto, Adulto anziano
Età minima
18 Years
Sessi idonei
Tutti
- Age 18-70
- Members of the Hellenic Cystic Fibrosis Association
- Willingness to participate on 13 sessions via Zoom
- Age over 70
- Not members of the Hellenic Cystic Fibrosis Association
- Not able to participate on 13 sessions via Zoom
Rakitzi, StavroulaParte responsabile dello studio
Dr. Stavroula Rakitzi, Investigatore principale, PhD, Clinical psychologist and cognitive behavioral psychotherapist, Rakitzi, Stavroula
Contatti principali dello studio
Contatto: Dr. Stavroula Rakitzi, PhD, +306989766935, [email protected]
Contatto: Mrs Anna Spinou, President of the Hellenic Cystic Fibrosis Association, Msc, +306944255853, [email protected]
1 Centri dello studio in 1 paesi
Private practice, ILISION 34 15771 Athens Greece, Athens, 15771, Greece
Dr. Stavroula Rakitzi, PhD, Contatto, +306989766935, [email protected]
Mrs Anna Spinou, President of the Hellenic Cystic Fibrosis Association, Msc, Contatto, +306944255853, [email protected]
In arruolamento