NCT07255131

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
32mo left

Started Sep 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress19%
Sep 2025Dec 2028

First Submitted

Initial submission to the registry

September 26, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

September 26, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 28, 2025

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2028

Last Updated

January 27, 2026

Status Verified

January 1, 2026

Enrollment Period

3.2 years

First QC Date

September 26, 2025

Last Update Submit

January 23, 2026

Conditions

Depression - Major Depressive DisorderAnxiety ChronicAnxietyFunctional OutcomeRecoveryObsessive Compulsive DisordersAssertiveness

Keywords

Cystic FibrosisGroup cognitive behavioral psychotherapy

Outcome Measures

Primary Outcomes (21)

  • 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

Study Arms (4)

Therapy group A patients with Cystic Fibrosis

EXPERIMENTAL

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

Control group B Patients with cystic fibrosis

ACTIVE COMPARATOR

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

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

Behavioral: Group C An online group cognitive behavioral psychotherapy in 13 sessions via Zoom

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

Behavioral: Group D An online group supportive psychotherapy in 13 sessions via Zoom

Interventions

Group A An online group cognitive behavioral psychotherapy in 13 sessions via ZoomBEHAVIORAL

An online group cognitive behavioral psychotherapy will be offered via Zoom in 13 sessions to the therapy Group A, to patients with cystic fibrosis

Also known as: Experimental
Therapy group A patients with Cystic Fibrosis
Group B An online group supportive psychotherapy in 13 sessions via ZoomBEHAVIORAL

An online group supportive psychotherapy will be offered via Zoom in 13 sessions to the control group Group B, to patients with cystic fibrosis

Also known as: Active comparator
Control group B Patients with cystic fibrosis
Group C An online group cognitive behavioral psychotherapy in 13 sessions via ZoomBEHAVIORAL

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

Also known as: Experimental
Therapy group C caregivers of patients with cystic fibrosis
Group D An online group supportive psychotherapy in 13 sessions via ZoomBEHAVIORAL

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

Also known as: Active comparator
Contol group D caregivers of patients with cystic fibrosis

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Private practice, ILISION 34 15771 Athens Greece

Athens, 15771, Greece

RECRUITING

Related Publications (12)

  • 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.

    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.

    PMID: 23459093BACKGROUND

  • 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.

    PMID: 25526940BACKGROUND

  • 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.

    PMID: 14399272BACKGROUND

  • 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.

    PMID: 14667249BACKGROUND

  • 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.

    BACKGROUND

MeSH Terms

Conditions

Anxiety DisordersCompulsive Personality DisorderCystic Fibrosis

Condition Hierarchy (Ancestors)

Mental DisordersPersonality DisordersPancreatic DiseasesDigestive System DiseasesLung DiseasesRespiratory Tract DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, Diseases

Study Officials

  • Dr. Stavroula Rakitzi

    Private Practice

    STUDY CHAIR

Central Study Contacts

Dr. Stavroula Rakitzi, PhD

CONTACT

+306989766935stavroula@rakitzi.onmicrosoft.com

Mrs Anna Spinou, President of the Hellenic Cystic Fibrosis Association, Msc

CONTACT

+306944255853cysticfibrosis.gr@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD, Clinical psychologist and cognitive behavioral psychotherapist

Study Record Dates

First Submitted

September 26, 2025

First Posted

November 28, 2025

Study Start

September 26, 2025

Primary Completion (Estimated)

December 20, 2028

Study Completion (Estimated)

December 20, 2028

Last Updated

January 27, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

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

Locations

GR(1)