Depression - Major Depressive DisorderRAKITZIHCFANCT07255131
The Effectiveness and Efficacy of an Online Cognitive Behavioral Psychotherapeutic Program
A study testing 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 and Group C An online group cognitive behavioral psychotherapy in 13 sessions via Zoom in people with Depression - Major Depressive Disorder and Anxiety Chronic, run by Rakitzi, Stavroula at 1 site in Greece.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Depression - Major Depressive Disorder, Anxiety Chronic, Anxiety
- What is being tested?
- 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 and Group C An online group cognitive behavioral psychotherapy in 13 sessions via Zoom
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteGreece
- Study dates
- 26 Sep 2025to 20 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-70
- Members of the Hellenic Cystic Fibrosis Association
- Willingness to participate on 13 sessions via Zoom
Who cannot join
- Age over 70
- Not members of the Hellenic Cystic Fibrosis Association
- Not able to participate on 13 sessions via Zoom
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mrs Anna Spinou, President of the Hellenic Cystic Fibrosis Association, Msc contact
Greece1 site, 1 recruiting
- Recruiting
Private practice, ILISION 34 15771 Athens Greece
Athens, 15771
Dr. Stavroula Rakitzi, PhD, +306989766935, stavroula@rakitzi.onmicrosoft.com
Mrs Anna Spinou, President of the Hellenic Cystic Fibrosis Association, Msc, +306944255853, cysticfibrosis.gr@gmail.com
About this study
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
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
Read the 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.
- Conditions
- Depression - Major Depressive Disorder, Anxiety Chronic, Anxiety, Functional Outcome, Recovery, Obsessive Compulsive Disorders
- Being tested
- 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
- Keywords
- Cystic Fibrosis, Group cognitive behavioral psychotherapy
- Medical subject headings
- Anxiety Disorders, Compulsive Personality Disorder, Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group A An online group cognitive behavioral psychotherapy in 13 sessions via ZoomBehavioural
Also called Experimental
An online group cognitive behavioral psychotherapy will be offered via Zoom in 13 sessions to the therapy Group A, to patients with cystic fibrosis
Group B An online group supportive psychotherapy in 13 sessions via ZoomBehavioural
Also called Active comparator
An online group supportive psychotherapy will be offered via Zoom in 13 sessions to the control group Group B, to patients with cystic fibrosis
Group C An online group cognitive behavioral psychotherapy in 13 sessions via ZoomBehavioural
Also called Experimental
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
Group D An online group supportive psychotherapy in 13 sessions via ZoomBehavioural
Also called Active comparator
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
| Study group | Role | What they receive |
|---|---|---|
| Therapy group A patients with Cystic Fibrosis | Experimental | Participation on an online group cognitive behavioral psychotherapy via Zoom in 13 sessions.
3 participants Receives: 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 Receives: 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 Receives: 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 Receives: Behavioral: Group D An online group supportive psychotherapy in 13 sessions via Zoom |
What is being measured
The primary outcome is the main question the study is designed to answer.
SCL-90-R
It evaluates psychopathology. T>60 means psychopathology. Low scores better
Measured: Preintervention
SCL-90-R
It evaluates psychopathology. T>60 means psychopathology. Low scores better
Measured: Immediately after the intervention
SCL-90-R
It evaluates psychopathology. T>60 means psychopathology. Low scores better
Measured: Follow-up up to 24 weeks
SRSDA
It measures Depression. Minimum 0 Maximum over 14. Low scores better
Measured: Preintervention
SRSDA
It measures Depression. Minimum 0 Maximum over 14. Low scores better
Measured: Immediately after intervention
SRSDA
It measures Depression. Minimum 0 Maximum over 14. Low scores better
Measured: Follow-up up to 24 weeks
SRSDA
It measures anxiety. Minimum 0 Maximum over 10. Low scores better
Measured: Preintervention
SRSDA
It measures anxiety. Minimum 0 Maximum over 10. Low scores better
Measured: Immediately after intervention
SRSDA
It measures anxiety. Minimum 0 Maximum over 10. Low scores better
Measured: 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)
Measured: 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)
Measured: 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)
Measured: Follow up up to 24 weeks
Hamilton Depression Scale
It measures depression. Minimum 0, maximum 23. Low scores better.
Measured: Preintervention
Hamilton Depression Scale
It measures depression. Minimum 0, maximum 23. Low scores better.
Measured: Immediately after the intervention
Hamilton Depression Scale
It measures depression. Minimum 0, maximum 23. Low scores better.
Measured: Follow up up to 24 weeks
WHODAS total
It measures functional outcome. Minimum 0, maximum 100. low scores better.
Measured: Preintervention
WHODAS total
It measures functional outcome. Minimum 0, maximum 100. low scores better.
Measured: Immediately after the intervention
WHODAS total
It measures functional outcome. Minimum 0, maximum 100. low scores better.
Measured: Follow up up to 24 weeks
RAS-DS total
Recovery. It measures recovery. Minimum 0, maximum 152. High scores better.
Measured: Preintervention
RAS-DS total
Recovery. It measures recovery. Minimum 0, maximum 152. High scores better.
Measured: Immediately after intervention
RAS-DS total
Recovery. It measures recovery. Minimum 0, maximum 152. High scores better.
Measured: Follow up up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2025
- Study start26 Sep 2025
- Primary completion20 Dec 2028 (estimated)
- Study completion20 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Depression - Major Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rakitzi, Stavroula
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Stavroula Rakitzi, Rakitzi, Stavroula
- Investigators
- Dr. Stavroula Rakitzi, Study chair, Private Practice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07255131
- Sponsor's protocol ID
- RAKITZI CYSTIC FIBROSIS
- Other IDs
- HELLENIC CYSTIC FIBROSIS ASSOC
- Acronym
- RAKITZIHCFA
- Status last verified
- Jan 2026
- First submitted
- 26 Sep 2025
- Last updated
- 27 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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
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.
PubMed 23459093Hancock 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.
PubMed 25526940HAMILTON 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.
PubMed 14399272Fountoulakis 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.
PubMed 14667249Fiedler, P. (2005). Verhaltenstherapie in Gruppen. Beltz.
Cohen, J. (1988). Statistical Power Analyses for the Behavioural Sciences. Erlbaum.
Bech, P. (1993). Rating scales for Psychopathology, Health Status and Quality of Life. Springer-Verlag.
Αntoniou, V., Εfthimiou, Κ., & Μilona, Κ.(2015). Social anxiety and assertiveness. A structured group cognitive behavioral program. IETHS.
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07255131
- Acronym / sponsor ID
- RAKITZIHCFA / RAKITZI CYSTIC FIBROSIS
- Conditions
- Depression - Major Depressive Disorder, Anxiety Chronic, Anxiety, Functional Outcome, Recovery, Obsessive Compulsive Disorders
- Keywords
- Cystic Fibrosis, Group cognitive behavioral psychotherapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Rakitzi, StavroulaUniversity, hospital or other
- Study start
- 26 Sep 2025 (actual)
- Primary completion
- 20 Dec 2028 (estimated)
- Study completion
- 20 Dec 2028 (estimated)
- First posted
- 28 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- 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
| Arm | Type | Receives |
|---|---|---|
| Therapy group A patients with Cystic Fibrosis | Experimental | Behavioral: Group A An online group cognitive behavioral psychotherapy in 13 sessions via ZoomParticipation on an online group cognitive behavioral psychotherapy via Zoom in 13 sessions. 3 participants |
| Control group B Patients with cystic fibrosis | Active comparator | Behavioral: Group B An online group supportive psychotherapy in 13 sessions via ZoomParticipation on an online group supportive psychotherapy via Zoom in 13 sessions. 2 participants |
| Therapy group C caregivers of patients with cystic fibrosis | Experimental | Behavioral: Group C An online group cognitive behavioral psychotherapy in 13 sessions via ZoomParticipation on an online group cognitive behavioral psychotherapy via Zoom in 13 sessions. 2 participants |
| Contol group D caregivers of patients with cystic fibrosis | Active comparator | Behavioral: Group D An online group supportive psychotherapy in 13 sessions via ZoomParticipation on an online group supportive psychotherapy via Zoom in 13 sessions. 2 participants |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18-70
- Members of the Hellenic Cystic Fibrosis Association
- Willingness to participate on 13 sessions via Zoom
Key exclusion criteria (3 listed)
- Age over 70
- Not members of the Hellenic Cystic Fibrosis Association
- Not able to participate on 13 sessions via Zoom
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group A An online group cognitive behavioral psychotherapy in 13 sessions via ZoomAlso: ExperimentalAn online group cognitive behavioral psychotherapy will be offered via Zoom in 13 sessions to the therapy Group A, to patients with cystic fibrosis | Behavioural | Therapy group A patients with Cystic Fibrosis |
| Group B An online group supportive psychotherapy in 13 sessions via ZoomAlso: Active comparatorAn online group supportive psychotherapy will be offered via Zoom in 13 sessions to the control group Group B, to patients with cystic fibrosis | Behavioural | Control group B Patients with cystic fibrosis |
| Group C An online group cognitive behavioral psychotherapy in 13 sessions via ZoomAlso: ExperimentalAn 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 | Behavioural | Therapy group C caregivers of patients with cystic fibrosis |
| Group D An online group supportive psychotherapy in 13 sessions via ZoomAlso: Active comparatorAn online group supportive psychotherapy will be offered via Zoom in 13 sessions to the control Group D, to caregivers of patients with cystic fibrosis | Behavioural | Contol group D caregivers of patients with cystic fibrosis |
Primary outcome
SCL-90-R
Time frame: Preintervention
It evaluates psychopathology. T>60 means psychopathology. Low scores better
SCL-90-R
Time frame: Immediately after the intervention
It evaluates psychopathology. T>60 means psychopathology. Low scores better
SCL-90-R
Time frame: Follow-up up to 24 weeks
It evaluates psychopathology. T>60 means psychopathology. Low scores better
SRSDA
Time frame: Preintervention
It measures Depression. Minimum 0 Maximum over 14. Low scores better
SRSDA
Time frame: Immediately after intervention
It measures Depression. Minimum 0 Maximum over 14. Low scores better
SRSDA
Time frame: Follow-up up to 24 weeks
It measures Depression. Minimum 0 Maximum over 14. Low scores better
SRSDA
Time frame: Preintervention
It measures anxiety. Minimum 0 Maximum over 10. Low scores better
SRSDA
Time frame: Immediately after intervention
It measures anxiety. Minimum 0 Maximum over 10. Low scores better
SRSDA
Time frame: Follow-up up to 24 weeks
It measures anxiety. Minimum 0 Maximum over 10. Low scores better
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)
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)
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)
Hamilton Depression Scale
Time frame: Preintervention
It measures depression. Minimum 0, maximum 23. Low scores better.
Hamilton Depression Scale
Time frame: Immediately after the intervention
It measures depression. Minimum 0, maximum 23. Low scores better.
Hamilton Depression Scale
Time frame: Follow up up to 24 weeks
It measures depression. Minimum 0, maximum 23. Low scores better.
WHODAS total
Time frame: Preintervention
It measures functional outcome. Minimum 0, maximum 100. low scores better.
WHODAS total
Time frame: Immediately after the intervention
It measures functional outcome. Minimum 0, maximum 100. low scores better.
WHODAS total
Time frame: Follow up up to 24 weeks
It measures functional outcome. Minimum 0, maximum 100. low scores better.
RAS-DS total
Time frame: Preintervention
Recovery. It measures recovery. Minimum 0, maximum 152. High scores better.
RAS-DS total
Time frame: Immediately after intervention
Recovery. It measures recovery. Minimum 0, maximum 152. High scores better.
RAS-DS total
Time frame: Follow up up to 24 weeks
Recovery. It measures recovery. Minimum 0, maximum 152. High scores better.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2026.
- BackgroundRakitzi, 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
- BackgroundRakitzi, S. (2023). Clinical psychology and cognitive behavioral psychotherapy. Recovery in mental health. Springer.
- BackgroundMayr, S., Erdfelder, E., Buchner, A., & Faul, F. (2007). A short tutorial of G-Power. Tutorials in Quantitative Methods in Psychology, 3(2), 51-59.
- BackgroundKoumpouros, 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: PubMed 23459093Hofmann 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.
- Background: PubMed 25526940Hancock 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.
- Background: PubMed 14399272HAMILTON 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.
- Background: PubMed 14667249Fountoulakis 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.
- BackgroundFiedler, P. (2005). Verhaltenstherapie in Gruppen. Beltz.
- BackgroundCohen, J. (1988). Statistical Power Analyses for the Behavioural Sciences. Erlbaum.
- BackgroundBech, P. (1993). Rating scales for Psychopathology, Health Status and Quality of Life. Springer-Verlag.
- BackgroundΑntoniou, V., Εfthimiou, Κ., & Μilona, Κ.(2015). Social anxiety and assertiveness. A structured group cognitive behavioral program. IETHS.
- Individual participant dataSharing planned: No. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mrs Anna Spinou, President of the Hellenic Cystic Fibrosis Association, Msc contact
Dr. Stavroula Rakitzi study chair
Private Practice
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 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 and Group C An online group cognitive behavioral psychotherapy in 13 sessions via Zoom in people with Depression - Major Depressive Disorder and Anxiety Chronic, run by Rakitzi, Stavroula at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr. Stavroula Rakitzi, PhD (+306989766935, stavroula@rakitzi.onmicrosoft.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SCL-90-R (time frame: Preintervention). The study lists 21 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07255131, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2026.