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The Effectiveness and Efficacy of an Online Cognitive Behavioral Psychotherapeutic Program

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07255131
Acronym
RAKITZIHCFA
Enrollment
52
Registered
2025-11-28
Start date
2025-09-26
Completion date
2028-12-20
Last updated
2026-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety, Anxiety Chronic, Assertiveness, Depression - Major Depressive Disorder, Functional Outcome, Obsessive Compulsive Disorders, Recovery

Keywords

Cystic Fibrosis, Group cognitive behavioral psychotherapy

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

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

BEHAVIORALGroup 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

BEHAVIORALGroup 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

BEHAVIORALGroup 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

BEHAVIORALGroup 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

Sponsors

Rakitzi, Stavroula
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
SCL-90-RPreinterventionIt evaluates psychopathology. T\>60 means psychopathology. Low scores better
SRSDAPreinterventionIt measures Depression. Minimum 0 Maximum over 14. Low scores better
U Uncertainty questionnairePreinterventionIt 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)
Hamilton Depression ScalePreinterventionIt measures depression. Minimum 0, maximum 23. Low scores better.
WHODAS totalPreinterventionIt measures functional outcome. Minimum 0, maximum 100. low scores better.
RAS-DS totalPreinterventionRecovery. It measures recovery. Minimum 0, maximum 152. High scores better.

Countries

Greece

Contacts

CONTACTDr. Stavroula Rakitzi, PhD
stavroula@rakitzi.onmicrosoft.com+306989766935
CONTACTMrs Anna Spinou, President of the Hellenic Cystic Fibrosis Association, Msc
cysticfibrosis.gr@gmail.com+306944255853
STUDY_CHAIRDr. Stavroula Rakitzi

Private Practice

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026