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NCT Number: NCT07255131

The Effectiveness and Efficacy of an Online Cognitive Behavioral Psychotherapeutic Program

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

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Key information

Conditions

Depression - Major Depressive Disorder Anxiety Anxiety Chronic Anxiety Disorders Assertiveness Compulsive Personality Disorder Congenital, Hereditary, and Neonatal Diseases and Abnormalities Cystic Fibrosis Digestive System Diseases Functional Outcome Genetic Diseases, Inborn Infant, Newborn, Diseases Lung Diseases Mental Disorders Obsessive Compulsive Disorders Pancreatic Diseases Personality Disorders Recovery Respiratory Tract Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Behavioral

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

Other names: Experimental

Group B An online group supportive psychotherapy in 13 sessions via Zoom

Behavioral

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

Other names: Active comparator

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

Behavioral

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

Other names: Experimental

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

Behavioral

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

Other names: Active comparator

Primary outcomes

  1. SCL-90-R

    Time frame: Preintervention

    It evaluates psychopathology. T>60 means psychopathology. Low scores better

  2. SCL-90-R

    Time frame: Immediately after the intervention

    It evaluates psychopathology. T>60 means psychopathology. Low scores better

  3. SCL-90-R

    Time frame: Follow-up up to 24 weeks

    It evaluates psychopathology. T>60 means psychopathology. Low scores better

  4. SRSDA

    Time frame: Preintervention

    It measures Depression. Minimum 0 Maximum over 14. Low scores better

  5. SRSDA

    Time frame: Immediately after intervention

    It measures Depression. Minimum 0 Maximum over 14. Low scores better

  6. SRSDA

    Time frame: Follow-up up to 24 weeks

    It measures Depression. Minimum 0 Maximum over 14. Low scores better

  7. SRSDA

    Time frame: Preintervention

    It measures anxiety. Minimum 0 Maximum over 10. Low scores better

  8. SRSDA

    Time frame: Immediately after intervention

    It measures anxiety. Minimum 0 Maximum over 10. Low scores better

  9. SRSDA

    Time frame: Follow-up up to 24 weeks

    It measures anxiety. Minimum 0 Maximum over 10. Low scores better

  10. U Uncertainty questionnaire

    Time frame: Preintervention

    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)

  11. U Uncertainty questionnaire

    Time frame: Immediately after the intervention

    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)

  12. U Uncertainty questionnaire

    Time frame: Follow up up to 24 weeks

    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)

  13. Hamilton Depression Scale

    Time frame: Preintervention

    It measures depression. Minimum 0, maximum 23. Low scores better.

  14. Hamilton Depression Scale

    Time frame: Immediately after the intervention

    It measures depression. Minimum 0, maximum 23. Low scores better.

  15. Hamilton Depression Scale

    Time frame: Follow up up to 24 weeks

    It measures depression. Minimum 0, maximum 23. Low scores better.

  16. WHODAS total

    Time frame: Preintervention

    It measures functional outcome. Minimum 0, maximum 100. low scores better.

  17. WHODAS total

    Time frame: Immediately after the intervention

    It measures functional outcome. Minimum 0, maximum 100. low scores better.

  18. WHODAS total

    Time frame: Follow up up to 24 weeks

    It measures functional outcome. Minimum 0, maximum 100. low scores better.

  19. RAS-DS total

    Time frame: Preintervention

    Recovery. It measures recovery. Minimum 0, maximum 152. High scores better.

  20. RAS-DS total

    Time frame: Immediately after intervention

    Recovery. It measures recovery. Minimum 0, maximum 152. High scores better.

  21. RAS-DS total

    Time frame: Follow up up to 24 weeks

    Recovery. It measures recovery. Minimum 0, maximum 152. High scores better.

Study contacts

Contact information is provided by the study sponsor or research team.

Dr. Stavroula Rakitzi, PhD

CONTACT

[email protected]

+306989766935

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

CONTACT

[email protected]

+306944255853

Sponsors and collaborators

Lead sponsor

Rakitzi, Stavroula

Other

Registry information

Official study 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

Acronym: RAKITZIHCFA

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Nov 28, 2025
Registry last updated
Jan 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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