The Effectiveness and Efficacy of an Online Cognitive Behavioral Psychotherapeutic Program (RAKITZIHCFA)

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

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

Study Overview

• Status: Recruiting
• Conditions: Anxiety; Recovery; Assertiveness; Depression - Major Depressive Disorder; Obsessive Compulsive Disorders; Anxiety Chronic; Functional Outcome
• Intervention / Treatment: Behavioral: Group A An online group cognitive behavioral psychotherapy in 13 sessions via Zoom; Behavioral: Group B An online group supportive psychotherapy in 13 sessions via Zoom; Behavioral: Group C An online group cognitive behavioral psychotherapy in 13 sessions via Zoom; Behavioral: Group D An online group supportive psychotherapy in 13 sessions via Zoom

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.

• Study Type: Interventional
• Enrollment (Estimated): 52
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dr. Stavroula Rakitzi, PhD; Phone Number: +306989766935; Email: Stavroula@Rakitzi.onmicrosoft.com
• Study Contact Backup: Name: Mrs Anna Spinou, President of the Hellenic Cystic Fibrosis Association, Msc; Phone Number: +306944255853; Email: cysticfibrosis.gr@gmail.com

Study Locations

• Greece
  • Athens, Greece, 15771
    • Recruiting
    • Private practice, ILISION 34 15771 Athens Greece
    • Contact: Dr. Stavroula Rakitzi, PhD; Phone Number: +306989766935; Email: Stavroula@Rakitzi.onmicrosoft.com
    • Contact: Mrs Anna Spinou, President of the Hellenic Cystic Fibrosis Association, Msc; Phone Number: +306944255853; Email: cysticfibrosis.gr@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age 18-70
• Members of the Hellenic Cystic Fibrosis Association
• Willingness to participate on 13 sessions via Zoom

Exclusion Criteria:

• Age over 70
• Not members of the Hellenic Cystic Fibrosis Association
• Not able to participate on 13 sessions via Zoom

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Therapy group A patients with Cystic Fibrosis; Participation on an online group cognitive behavioral psychotherapy via Zoom in 13 sessions. 3 participants	Behavioral: 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; Other Names: Experimental
Active Comparator: Control group B Patients with cystic fibrosis; Participation on an online group supportive psychotherapy via Zoom in 13 sessions. 2 participants	Behavioral: 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; Other Names: Active comparator
Experimental: Therapy group C caregivers of patients with cystic fibrosis; Participation on an online group cognitive behavioral psychotherapy via Zoom in 13 sessions. 2 participants	Behavioral: 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; Other Names: Experimental
Active Comparator: Contol group D caregivers of patients with cystic fibrosis; Participation on an online group supportive psychotherapy via Zoom in 13 sessions. 2 participants	Behavioral: 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 Names: Active comparator

What is the study measuring?

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
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
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
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.	Follow up up to 24 weeks
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

Collaborators and Investigators

• Sponsor: Rakitzi, Stavroula
• Investigators: Study Chair: Dr. Stavroula Rakitzi, Private Practice

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 26, 2025
• Primary Completion (Estimated): December 20, 2028
• Study Completion (Estimated): December 20, 2028

Study Registration Dates

• First Submitted: September 26, 2025
• First Submitted That Met QC Criteria: November 19, 2025
• First Posted (Actual): November 28, 2025

Study Record Updates

• Last Update Posted (Actual): January 27, 2026
• Last Update Submitted That Met QC Criteria: January 23, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Cystic Fibrosis; Group cognitive behavioral psychotherapy
• Additional Relevant MeSH Terms: Mental Disorders; Genetic Diseases, Inborn; Respiratory Tract Diseases; Digestive System Diseases; Lung Diseases; Infant, Newborn, Diseases; Pancreatic Diseases; Personality Disorders; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Anxiety Disorders; Cystic Fibrosis; Compulsive Personality Disorder
• Other Study ID Numbers: RAKITZI CYSTIC FIBROSIS; HELLENIC CYSTIC FIBROSIS ASSOC (Other Identifier: HELLENIC CYSTIC FIBROSIS ASSOCIATION & DR. STAVROULA RAKITZI)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No