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| ID | Type | Description | Link |
|---|---|---|---|
| HELLENIC CYSTIC FIBROSIS ASSOC | Other Identifier | HELLENIC CYSTIC FIBROSIS ASSOCIATION & DR. STAVROULA RAKITZI |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Therapy group A patients with Cystic Fibrosis | Experimental | Participation on an online group cognitive behavioral psychotherapy via Zoom in 13 sessions. 3 participants |
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| Control group B Patients with cystic fibrosis | Active Comparator | Participation on an online group supportive psychotherapy via Zoom in 13 sessions. 2 participants |
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| Therapy group C caregivers of patients with cystic fibrosis | Experimental | Participation on an online group cognitive behavioral psychotherapy via Zoom in 13 sessions. 2 participants |
|
| Contol group D caregivers of patients with cystic fibrosis | Active Comparator | Participation on an online group supportive psychotherapy via Zoom in 13 sessions. 2 participants |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Group A An online group cognitive behavioral psychotherapy in 13 sessions via Zoom | Behavioral | An online group cognitive behavioral psychotherapy will be offered via Zoom in 13 sessions to the therapy Group A, to patients with cystic fibrosis |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dr. Stavroula Rakitzi, PhD | Contact | +306989766935 | stavroula@rakitzi.onmicrosoft.com | |
| Mrs Anna Spinou, President of the Hellenic Cystic Fibrosis Association, Msc | Contact | +306944255853 | cysticfibrosis.gr@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Dr. Stavroula Rakitzi | Private Practice | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Private practice, ILISION 34 15771 Athens Greece | Recruiting | Athens | 15771 | Greece |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 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 | ||
| Background | Rakitzi, S. (2023). Clinical psychology and cognitive behavioral psychotherapy. Recovery in mental health. Springer. | ||
| Background | 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. | ||
| Background | 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. | ||
| 23459093 |
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This is our first effectiveness and efficacy study regarding the comparison of the online group cognitive behavioral program for patients with cystic fibrosis and caregivers in comparison to control groups
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 1, 2025 |
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A therapy group with patients with cystic fibrosis will be compared with a control group with patients with cystic fibrosis. A therapy group with caregivers will be compared with a control group with cqaregivers
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| Group B An online group supportive psychotherapy in 13 sessions via Zoom | Behavioral | An online group supportive psychotherapy will be offered via Zoom in 13 sessions to the control group Group B, to patients with cystic fibrosis |
|
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| Group C An online group cognitive behavioral psychotherapy in 13 sessions via Zoom | Behavioral | 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 |
|
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| Group D An online group supportive psychotherapy in 13 sessions via Zoom | Behavioral | 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 |
|
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| 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 |
| Background |
| 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. |
| 25526940 | Background | 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. |
| 14399272 | Background | 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. |
| 14667249 | Background | 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. |
| Background | Fiedler, P. (2005). Verhaltenstherapie in Gruppen. Beltz. |
| Background | Cohen, J. (1988). Statistical Power Analyses for the Behavioural Sciences. Erlbaum. |
| Background | Bech, P. (1993). Rating scales for Psychopathology, Health Status and Quality of Life. Springer-Verlag. |
| Background | Αntoniou, V., Εfthimiou, Κ., & Μilona, Κ.(2015). Social anxiety and assertiveness. A structured group cognitive behavioral program. IETHS. |
| Nov 19, 2025 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 1, 2025 | Nov 19, 2025 | ICF_001.pdf |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D003193 | Compulsive Personality Disorder |
| D003550 | Cystic Fibrosis |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D010554 | Personality Disorders |
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |
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