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Recruiting NCT07255131

The Effectiveness and Efficacy of an Online Cognitive Behavioral Psychotherapeutic Program

No phase Interventional Depression - Major Depressive Disorder Anxiety Chronic Anxiety Functional Outcome

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Group A An online group cognitive behavioral psychotherapy in 13 sessions via Zoom, Group B An online group supportive psychotherapy in 13 sessions via Zoom, Group C An online group cognitive behavioral psychotherapy in 13 sessions via Zoom, Group D An online group supportive psychotherapy in 13 sessions via Zoom.
Who it may be relevant to
Registry conditions: Depression - Major Depressive Disorder, Anxiety Chronic, Anxiety, Functional Outcome. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Greece
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

  • 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
  • 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
  • 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
  • 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

Primary outcome measures

  • SCL-90-R [Time frame: Preintervention]
  • SCL-90-R [Time frame: Immediately after the intervention]
  • SCL-90-R [Time frame: Follow-up up to 24 weeks]
  • SRSDA [Time frame: Preintervention]
  • SRSDA [Time frame: Immediately after intervention]
  • SRSDA [Time frame: Follow-up up to 24 weeks]
  • SRSDA [Time frame: Preintervention]
  • SRSDA [Time frame: Immediately after intervention]
  • SRSDA [Time frame: Follow-up up to 24 weeks]
  • U Uncertainty questionnaire [Time frame: Preintervention]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Greece · 1 center
  • Private practice, ILISION 34 15771 Athens Greece — Athens

Publications

  • 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. PMID 23459093
  • 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 25526940
  • 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 14399272
  • 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 14667249

Identifiers

NCT: NCT07255131 · RAKITZI CYSTIC FIBROSIS · HELLENIC CYSTIC FIBROSIS ASSOC

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗