The Effectiveness and Efficacy of an Online Cognitive Behavioral Psychotherapeutic Program
NCT ID: NCT07255131
Last Updated: 2026-01-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
52 participants
INTERVENTIONAL
2025-09-26
2028-12-20
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Therapy group A patients with Cystic Fibrosis
Participation on an online group cognitive behavioral psychotherapy via Zoom in 13 sessions.
3 participants
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
Control group B Patients with cystic fibrosis
Participation on an online group supportive psychotherapy via Zoom in 13 sessions.
2 participants
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
Therapy group C caregivers of patients with cystic fibrosis
Participation on an online group cognitive behavioral psychotherapy via Zoom in 13 sessions.
2 participants
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
Contol group D caregivers of patients with cystic fibrosis
Participation on an online group supportive psychotherapy via Zoom in 13 sessions.
2 participants
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
Interventions
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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
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
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
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Members of the Hellenic Cystic Fibrosis Association
* Willingness to participate on 13 sessions via Zoom
Exclusion Criteria
* Not members of the Hellenic Cystic Fibrosis Association
* Not able to participate on 13 sessions via Zoom
18 Years
70 Years
ALL
No
Sponsors
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Rakitzi, Stavroula
OTHER
Responsible Party
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Dr. Stavroula Rakitzi
PhD, Clinical psychologist and cognitive behavioral psychotherapist
Principal Investigators
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Dr. Stavroula Rakitzi
Role: STUDY_CHAIR
Private Practice
Locations
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Private practice, ILISION 34 15771 Athens Greece
Athens, , Greece
Countries
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Central Contacts
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Mrs Anna Spinou, President of the Hellenic Cystic Fibrosis Association, Msc
Role: CONTACT
Facility Contacts
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Mrs Anna Spinou, President of the Hellenic Cystic Fibrosis Association, Msc
Role: backup
References
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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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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HELLENIC CYSTIC FIBROSIS ASSOC
Identifier Type: OTHER
Identifier Source: secondary_id
RAKITZI CYSTIC FIBROSIS
Identifier Type: -
Identifier Source: org_study_id
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