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Clinical Trial NCT07255131 (RAKITZIHCFA) for Depression - Major Depressive Disorder, Anxiety Chronic, Anxiety, Functional Outcome, Recovery, Obsessive Compulsive Disorders, Assertiveness is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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The Effectiveness and Efficacy of an Online Cognitive Behavioral Psychotherapeutic Program (RAKITZIHCFA)
Clinical Trial NCT07255131 (RAKITZIHCFA) is an interventional study for Depression - Major Depressive Disorder, Anxiety Chronic, Anxiety, Functional Outcome, Recovery, Obsessive Compulsive Disorders, Assertiveness that is recruiting. It started on 26 September 2025 with plans to enroll 52 participants. Led by Rakitzi, Stavroula, it is expected to complete by 20 December 2028. The latest data from ClinicalTrials.gov was last updated on 28 November 2025.
Brief Summary
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
Detailed Description
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.
Official Title
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
Conditions
Depression - Major Depressive DisorderAnxiety ChronicAnxietyFunctional OutcomeRecoveryObsessive Compulsive DisordersAssertivenessPublications
Scientific articles and research papers published about this clinical trial:- 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.
Other Study IDs
- RAKITZIHCFA
- RAKITZI CYSTIC FIBROSIS
- HELLENIC CYSTIC FIBROSIS ASSOC (Other Identifier) (HELLENIC CYSTIC FIBROSIS ASSOCIATION & DR. STAVROULA RAKITZI)
NCT ID Number
Start Date (Actual)
2025-09-26
Last Update Posted
2025-11-28
Completion Date (Estimated)
2028-12-20
Enrollment (Estimated)
52
Study Type
Interventional
PHASE
N/A
Status
Recruiting
Keywords
Cystic Fibrosis
Group cognitive behavioral psychotherapy
Group cognitive behavioral psychotherapy
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Single
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
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 |
Active ComparatorControl 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 |
Active ComparatorContol 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 |
Primary Outcome Measures
| Outcome Measure | 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 |
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 |
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
- 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, StavroulaStudy Responsible Party
Dr. Stavroula Rakitzi, Principal Investigator, PhD, Clinical psychologist and cognitive behavioral psychotherapist, Rakitzi, Stavroula
Study Central Contact
Contact: Dr. Stavroula Rakitzi, PhD, +306989766935, [email protected]
Contact: Mrs Anna Spinou, President of the Hellenic Cystic Fibrosis Association, Msc, +306944255853, [email protected]
1 Study Locations in 1 Countries
Private practice, ILISION 34 15771 Athens Greece, Athens, 15771, Greece
Dr. Stavroula Rakitzi, PhD, Contact, +306989766935, [email protected]
Mrs Anna Spinou, President of the Hellenic Cystic Fibrosis Association, Msc, Contact, +306944255853, [email protected]
Recruiting