Actively Recruiting

Phase Not Applicable
Age: 18Years - 70Years
All Genders
ID07255131

The Effectiveness and Efficacy of an Online Group Cognitive Behavioral Psychotherapy in Patients With Cystic Fibrosis and Caregivers Compared to Control Groups

Led by Rakitzi, Stavroula · Updated on 2026-01-27

52

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the effectiveness of an online group cognitive behavioral psychotherapeutic program for patients with cystic fibrosis and their caregivers. This randomized controlled trial compares this program with an online group supportive psychotherapeutic program to understand how these therapies impact depression, anxiety, recovery, and functional outcomes. The study is sponsored by Stavroula Rakitzi and conducted by the Hellenic Cystic Fibrosis Association. Participants are divided into four groups: two therapy groups receiving the cognitive behavioral psychotherapy and two control groups receiving supportive psychotherapy. Each group participates in 13 weekly sessions conducted online via Zoom. One therapy and one control group consist of patients with cystic fibrosis, while the other therapy and control groups include caregivers of these patients. Throughout the study, participants will complete various assessments at three points: before the intervention, immediately after, and up to 24 weeks after completion. These assessments include measures of symptoms, uncertainty, depression, disability, and recovery. The study carefully monitors participant progress and outcomes to evaluate the therapy programs. Total participation spans the duration of the 13 sessions plus follow-up assessments over 24 weeks.

CONDITIONS

Brief Title

The Effectiveness and Efficacy of an Online Cognitive Behavioral Psychotherapeutic Program

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18-70 years
  • Members of the Hellenic Cystic Fibrosis Association
  • Willingness to participate in 13 weekly sessions via Zoom
Not Eligible

You will not qualify if you...

  • Age over 70 years
  • Not a member of the Hellenic Cystic Fibrosis Association
  • Unable to participate in 13 weekly sessions via Zoom

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person or online) for eligibility assessment

Outpatient Treatment

Duration - 13 weeks

Participants attend 13 weekly online group psychotherapy sessions via Zoom, either cognitive behavioral therapy or supportive psychotherapy, depending on their group assignment.

Weekly sessions for 13 weeks via Zoom

Follow-up

Duration - Up to 24 weeks after treatment

Participants complete follow-up assessments up to 24 weeks after the intervention to evaluate the lasting effects of the psychotherapy program.

Assessments at immediate post-intervention and follow-up visits up to 24 weeks

Trial Site Locations

Total: 1 location

1

Private practice, ILISION 34 15771 Athens Greece

Athens, Greece, 15771

Actively Recruiting

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Research Team

D

Dr. Stavroula Rakitzi, PhD

M

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

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

4

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Published Research Related To This Trial

The Greek translation of the symptoms rating scale for depression and anxiety: preliminary results of the validation study.

Konstantinos N Fountoulakis, Apostolos Iacovides, Soula Kleanthous...

https://pubmed.ncbi.nlm.nih.gov/14667249