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The Effectiveness and Efficacy of an Online Cognitive Behavioral Psychotherapeutic Program (RAKITZIHCFA)
Os detalhes do estudo clínico estão disponíveis principalmente em inglês. No entanto, a IA Trial Radar pode ajudar! Basta clicar em 'Explicar o estudo' para visualizar e discutir as informações do estudo no idioma selecionado.
O estudo clínico NCT07255131 (RAKITZIHCFA) é um ensaio intervencionista para Depression - Major Depressive Disorder, Anxiety Chronic, Ansiedade, Desfecho funcional, Recuperação, Obsessive Compulsive Disorders, Assertiveness. Seu status atual é: recrutando. O estudo começou em 26 de setembro de 2025 e pretende incluir 52 participantes. Coordenado por Rakitzi, Stavroula e deve ser concluído em 20 de dezembro de 2028. Essas informações foram atualizadas no ClinicalTrials.gov em 28 de novembro de 2025.
Resumo
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
Descrição detalhada
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.
Título oficial
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
Condições
Depression - Major Depressive DisorderAnxiety ChronicAnsiedadeDesfecho funcionalRecuperaçãoObsessive Compulsive DisordersAssertivenessPublicações
Artigos científicos e trabalhos de pesquisa publicados sobre este estudo clínico:- 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.
Outros IDs do estudo
- RAKITZIHCFA
- RAKITZI CYSTIC FIBROSIS
- HELLENIC CYSTIC FIBROSIS ASSOC (Outro identificador) (HELLENIC CYSTIC FIBROSIS ASSOCIATION & DR. STAVROULA RAKITZI)
Número NCT
Data de início (real)
2025-09-26
Última atualização postada
2025-11-28
Data de conclusão (estimada)
2028-12-20
Inscrição (estimada)
52
Tipo de estudo
Intervencionista
FASE
N/A
Status
Recrutando
Palavras-chave
Cystic Fibrosis
Group cognitive behavioral psychotherapy
Group cognitive behavioral psychotherapy
Propósito principal
Tratamento
Alocação do design
Randomizado
Modelo de intervenção
Atribuição paralela
Cegamento (Mascaramento)
Simples-cego
Braços / Intervenções
| Grupo de participantes/Braço | Intervenção/Tratamento |
|---|---|
ExperimentalTherapy 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 |
Comparador ativoControl 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 |
ExperimentalTherapy 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 |
Comparador ativoContol 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 |
Desfecho primário
| Medida de desfecho | Descrição da medida | Prazo |
|---|---|---|
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 |
Critérios de elegibilidade
Idades elegíveis
Adulto, Adulto mais velho
Idade mínima
18 Years
Sexos elegíveis
Todos
- 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, StavroulaResponsável pelo estudo
Dr. Stavroula Rakitzi, Investigador principal, PhD, Clinical psychologist and cognitive behavioral psychotherapist, Rakitzi, Stavroula
Contato central do estudo
Contato: Dr. Stavroula Rakitzi, PhD, +306989766935, [email protected]
Contato: Mrs Anna Spinou, President of the Hellenic Cystic Fibrosis Association, Msc, +306944255853, [email protected]
1 Locais do estudo em 1 países
Private practice, ILISION 34 15771 Athens Greece, Athens, 15771, Greece
Dr. Stavroula Rakitzi, PhD, Contato, +306989766935, [email protected]
Mrs Anna Spinou, President of the Hellenic Cystic Fibrosis Association, Msc, Contato, +306944255853, [email protected]
Recrutando