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
Phase: NA
Conditions: Depression - Major Depressive Disorder, Anxiety Chronic, Anxiety, Functional Outcome, Recovery, Obsessive Compulsive Disorders, Assertiveness
Sponsor: Rakitzi, Stavroula

1 
 
 
                                                                                       Athens, 1.11.2025 
Unique Protocol ID: RAKITZI CYSTIC FIBROSIS 
Official title of the study: 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 
Brief title: The effectiveness and efficacy of an online cognitive behavioral 
psychotherapeutic program (RAKITZIHCFA) 
NCT: not available 

2 
 
 
Sponsor: Dr. Stavroula Rakitzi 
Dr. phil., Dipl.-Psych., Stavroula Rakitzi 
 
Clinical psychologist and cognitive behavioral psychotherapist 
Private practice 
ILISION 34 15771 Athens Greece 
 
2111180571 
 
6989766935 
 
Stavroula@Rakitzi.onmicrosoft.com 
 
srakitzi@gmail.com 
 
Description linkedin Stavroula Rakitzi 
ORCID: http://0000-0002-5231-6619 
In collaboration with the Hellenic Cystic Fibrosis Association (www.cysticfibrosis.gr/en) 
 
President: Anna Spinou 
 
Karaiskaki street 28 105 54 Athens Greece 
 
Tel: +302110137700, +306944255853 
 
E-mail: info@cysticfibrosis.gr 

3 
 
1. Introduction 
Cognitive behavioral psychotherapy presents evidence-based psychotherapy and is one 
 
of the most effective psychotherapies today for all mental health disorders. Many studies are 
published (Hoffmann et al., 2012). 
An online group cognitive behavioral psychotherapy for patients with cystic fibrosis and for 
caregivers is offered voluntary by Dr. Stavroula Rakitzi to the members of the Hellenic Cystic 
Fibrosis Association since 2022 until today. The first positive results of this implementation 
have been published (Rakitzi, 2023; Rakitzi et al., 2025). This program is a recovery-oriented 
psychotherapy (Rakitzi, 2023; Rakitzi et al., 2025). 
This research protocol aims to evaluate the efficacy of this online group cognitive behavioral 
program for patients with cystic fibrosis and caregivers in comparison with control groups in a 
randomized controlled trial for the first time in Greece. 
 
 
2. Material and Methods 
 
2.1. 
Compliance with ethical standards 
 
Prior to the study’s inclusion, the patients will read and sign written informed consent for their 
involvement in this research project and for the publication of the results. Information that 
could reveal the patients’ identities was left out. The authors adhere to the APA ethical 
standards and to Helsinki. 
The study was approved by the scientific and ethical committee of the Hellenic Cystic Fibrosis 
Association (896/24/09/2025). The study will be registered in clinicalTrials.gov. 
2.2 Sample size calculation 
 
G power (Mayr et al., 2007) was used to calculate the sample size. Following parameters were 
chosen: t-test mean difference between two independent means (2 groups), Type of power 
analysis: compute required sample size with a given α, power and effect size. 
Tail one, effect size: 0.70 (Rakitzi et al., 2025), α=0.05, power(1-β)=0.80, ratio N2/N1 1. 
Following results are given: noncentrality parameter δ:2.52, t:1.67, Df:50, sample size Group 
1:26, sample size Group 2:26, Total sample size: 52, actual power: 0.80. 

4 
 
 
 
2.2. Study design 
It is a randomized controlled trial. The online group cognitive behavioral psychotherapy for 
patients with cystic fibrosis will be compared with a control group and the online group 
cognitive behavioral psychotherapy for caregivers will be also compared with a control group. 
The online-group cognitive-behavioral program is offered by Dr. S. Rakitzi in two therapy 
groups: in patients with cystic fibrosis and afterward in caregivers of patients with cystic 
fibrosis once a week on the same day in different hours via Zoom. Mrs E. Pavlidi, psychologist 
of the Hellenic Cystic Fibrosis Association, will offer a supportive group in the two control 
groups once a week on the same day in different hours via Zoom. 
 
 
2. 3. Participants 
Members of the Hellenic Cystic Fibrosis Association can join this research protocol. The call 
for interest is posted on the association's website approximately 2 months before the start of 
therapies. The prerequisites for participation are the following: age 18-65, membership of the 
association, commitment to participate within the treatment at the time and day indicated and 
the ability to utilize Zoom with sound and video (inclusion criteria). Up to three absences are 
permitted for participants. The treatment is terminated for anyone who over this threshold 
(exclusion criteria). 
The online treatment was chosen due to the participation of members from all over Greece and 
the safety distances for health reasons, which must be kept up by patients with cystic fibrosis. 

5 
 
 
2. 4. Therapy 
Dr. S. Rakitzi will offer to every participant of all 4 groups an individual session, in which the 
research protocol will be explained, a motivational interview will be conducted and finally a 
written informed consent for participation will be offered. Afterwards, the psychometric tests 
will be sent to the participant. 
After these motivational interviews and the evaluation of the tests before the therapy, 
participants will be assigned to the treatment group (patients, caregivers) or the patient and 
caregiver control group by lottery. 
A group online cognitive behavioral psychotherapy for two therapy groups (patients with cystic 
fibrosis and caregivers) is applied once a week for 13 sessions, and each session lasts 1.5 hours 
by Dr. S. Rakitzi. It is a combination of cognitive-behavioral interventions which point out to 
decrease stress, improve mood and strengthen assertiveness, and introduce grief. All these 
interventions are adjusted to cystic fibrosis. The therapy is focused on recovery. 
A group online supportive psychotherapy for two control groups (patients with cystic fibrosis 
and caregivers) is applied once a week for 13 sessions, and each session lasts 1.5 hours by Mrs 
E. Pavlidi, psychologist. 
 
 
2. 5. Measures 
 
All measures will be given by a blind rater, a psychologist (Msc clinical psychology) before, 
after the therapy and in a follow up after 6 months. The blind rater doesn’t know the participants 
and doesn’t know anything about this project. 

6 
 
 
 
2. 5. 1. Psychopathology 
Psychopathology will be evaluated by the Greek adaptations of the reliable and valid 
instruments SCL-90-R (Donias et al., 1991) (self-test), and Symptoms Rating Scale for 
Depression and Anxiety (SRSDA) (Bech, 1993; Fountoulakis et al., 2003) (self-test). 
Depression will be evaluated also from the Hamilton Depression Scale (HAM-D) (Hamilton, 
1960) (the Greek version), (Clinician evaluation). 
2. 5. 2. Social skills 
 
Social skills will be evaluated by the valid and reliable (U-Unsicherheitsfragebögen)-test, 
which is translated in Greek, with following the domains: fear of criticism, fear of contact, 
assertiveness, difficulty of saying no, guilt and decency (Antoniou et al., 2015; Ulrich et al., 
1977) (self-test). 
2. 5. 3. Functional outcome 
 
Functional outcome will be evaluated by the Greek adaptation of valid and reliable WHODAS 
with the following domains: 1: Cognitive Function – (understanding and communication); 2: 
Mobility – (movement and ease of movement); 3: Self-care – (personal hygiene care, dressing, 
eating and living independently); 4: Socializing/Social contacts – (interacting with other 
people); 5: Life activities – (household responsibilities, leisure, work and school); and 6: 
Participation – (inclusion in community activities, participation in society); and WHODAS 
total (Koumpouros et al., 2018; WHO, 2001) (self-test). 

7 
 
 
 
 
 
2. 5. 4. Recovery 
 
Recovery will be evaluated by the Greek adaptation of the valid and reliable RAS-DS with the 
following domains: RAS-DS total, R1: doing things I value, R2: looking forward, R3: 
mastering my illness, and R4: connecting and belonging (Hancock et al., 2015, 2018, 2019, 
2023; Ramesh et al., 2024) (self-test). 
 
 
 
 
3. Statistical analysis 
The SPSS 13 Version will be used for statistical analysis. A general linear model and regression 
analysis will be conducted. Effect sizes will be also calculated. According to Cohen d=0.2 is a 
small effect size, d=0.4 is a medium effect size, and d=0.8 a large effect size. Pearson 
correlation coefficients will be calculated (Bortz & Döring, 2002; Cohen, 1988). 
 
 
This research protocol will begin at 15. 11. 2025 with motivational interviews and 
the evaluation of the tests before the therapy. The 4 groups will begin on 17. 1 
2026. The research protocol will end on December 2028. 

8 
 
 
 
4. References 
 
Αntoniou, V., Εfthimiou, Κ., & Μilona, Κ.(2015). Social anxiety and assertiveness. A 
structured group cognitive behavioral program. IETHS. 
Bech, P. (1993). Rating scales for Psychopathology, Health Status and Quality of Life. 
 
Springer-Verlag. 
 
Bortz, J., & Döring, N. (2002). Forschungsmethoden und Evaluation für Human- und 
Sozialwissenschaftler. Springer. 
Cohen, J. (1988). Statistical Power Analyses for the Behavioural Sciences. Erlbaum. 
Donias, S., Karastergiou, A., & Manos, N. (1991). Standardization of the symptom checklist- 
90-R rating scale in a Greek population. Psychiatriki, 2(1), 42–48. 
Fiedler, P. (2005). Verhaltenstherapie in Gruppen. Beltz. 
 
Fountoulakis, K.N., Iacovides, A., Kleanthous, S., Samolis, S., Gougoulias, K., Kaprinis, G. 
St., & Bech, P. (2003). The Greek translation of the symptoms rating scale for depression and 
anxiety: preliminary results of the validation study. 
BMC Psychiatry, 3, 21. 
http://www.biomedcentral.com/1471-244X/3/21. 
Hamilton, M. (1960). A rating scale for depression. Journal of Neurology, Neurosurgery and 
Psychiatry, 23(1), 56-62. 
Hancock, N., Scanlan, J.N., Bundy, A.C., & Honey, A. (2019). Recovery Assessment Scale – 
Domains & Stages (RAS‐DS) Manual‐ Version 3. University of Sydney. 
Hancock, N., & the University of Sydney (2023). Rakitzi, S. Katoudi, S, Recovery Assessment 
Scale-Domains & Stages (RAS-DS). The Greek version. University of Sydney. 
Hancock, N., Scanlan, J., Honey, A., Bundy, A., & O'Shea, K. (2015). Recovery Assessment 
Scale – Domains & Stages (RAS-DS): Its Feasibility and Outcome Measurement Capacity. 

9 
 
Australian 
and 
New 
Zealand 
Journal 
of 
Psychiatry, 
49(7), 
624633.http://dx.doi.org/10.1177/0004867414564084 
Hofmann, S.G., Asnaani, A., Vonk, I.J.J., Sawyer, A.T., & Fang, A. (2012). The efficacy of 
Cognitive Behavioral Therapy: A Review of Meta-analyses. Cognitive Therapy and Research, 
36(5), 427-440. https://doi.org/10.1007/s10608-012-9476-1. 
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. 
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. 
Rakitzi, S. (2023). Clinical psychology and cognitive behavioral psychotherapy. Recovery in 
mental health. Springer. 
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 
Ulrich, R., & Ulrich, de Muynck R. (1977). Der Fehlschlagangst-Fragebögen. Pfeifer. 
 
WHO. (2001). International classification of functioning, disability and health (ICF). World 
Health Organization.