Postpartum DepressionNCT07267702
Postpartum 1-Day CBT Pilot Study (Türkiye)
A study testing One-Day Online CBT-Based Workshop in people with Postpartum Depression, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
This pilot randomized controlled trial aims to evaluate the feasibility, acceptability, and preliminary effects of a culturally adapted, one-day online Cognitive Behavioral Therapy (CBT)-based group workshop for women with postpartum depression in Türkiye. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Postpartum Depression
- What is being tested?
- One-Day Online CBT-Based Workshop
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Dec 2025to Jul 2026
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Female participants aged 18-45 years
- Having an infant aged 1-12 months
- Presence of clinically relevant postpartum depressive symptoms (EPDS ≥10)
- Literate in Turkish (able to read and write)
- Access to a stable internet connection
- Willing and able to provide informed consent
Who cannot join
- Current psychotic, bipolar, organic mental, or substance use disorder
- Severe depressive episode or impaired judgment due to psychiatric illness
- Active suicidal ideation or intent
- Medical or neurological condition preventing participation (e.g., dementia, intellectual disability, severe hearing or visual impairment)
- Infant with a life-threatening congenital disorder
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Marmara University, Department of Psychiatry
Istanbul, Marmara, 34854
Büşra Kalaça, MD, +90536 949 2031 ext. +90216 6254545, busraergut11@gmail.com
Ayşe Sakallı Kani, MD, +9505 814 9354 ext. +90216 6254545, asakalli@marmara.edu.tr
About this study
Official title: Cultural Adaptation of a One-Day Online Cognitive Behavioral Therapy Group Workshop for Postpartum Depression in Türkiye: A Pilot Randomized Controlled Trial
This pilot randomized controlled trial aims to evaluate the feasibility, acceptability, and preliminary effects of a culturally adapted, one-day online Cognitive Behavioral Therapy (CBT)-based group workshop for women with postpartum depression in Türkiye. The intervention was adapted from a validated model developed in Ontario, Canada, using Bernal's cultural adaptation framework.
Participants will be randomly assigned in a 1:1 ratio to either a workshop group, who will receive the one-day online CBT-based workshop within the first month after enrollment, or a control group who will continue to receive usual postpartum care throughout the study period. Data will be collected at baseline and at the 3-month follow-up using the Edinburgh Postnatal Depression Scale (EPDS), Patient Health Questionnaire-9 (PHQ-9), Generalized Anxiety Disorder-7 (GAD-7), the Frequency of Actions and Thoughts Scale (FATS), and the TÜRBAD Satisfaction Questionnaire (TÜRBAD-SQ).
Read more
The study will assess feasibility indicators including recruitment, randomization procedures, completion of study questionnaires, retention through the 3-month follow-up, and adherence to the one-day workshop. Acceptability and preliminary changes in depressive, anxiety, and cognitive-behavioral outcomes will also be explored.
This pilot trial represents the first culturally adapted, one-day online CBT-based group intervention for postpartum depression in Türkiye and will inform the design of a future large-scale randomized controlled trial.
Read the detailed description
Postpartum depression (PPD) is a major public health concern affecting approximately one in five women worldwide and nearly one in five mothers in Türkiye. Despite its high prevalence, access to brief, evidence-based, and scalable psychological interventions remains limited, particularly in low- and middle-income settings. Untreated PPD increases the risk of chronic depression, impaired mother-infant bonding, and adverse emotional, behavioral, and developmental outcomes in children.
Cognitive Behavioral Therapy (CBT) is recommended as a first-line treatment for mild to moderate depression in the perinatal period; however, conventional CBT typically requires 12-15 weekly sessions, which can be difficult for new mothers due to caregiving demands, time limitations, and social isolation. Group-based interventions promote normalization and peer support but remain relatively inaccessible. Therefore, brief, structured, and scalable models are urgently needed.
A one-day CBT-based group workshop developed in Ontario, Canada has demonstrated feasibility, acceptability, and effectiveness in reducing postpartum depression. This study represents one of the first efforts to culturally adapt and evaluate this workshop for women in Türkiye. The adaptation followed Bernal's cultural adaptation framework to ensure conceptual, linguistic, and contextual relevance. All intervention materials were refined and finalized for pilot implementation following this adaptation phase.
This pilot randomized controlled trial aims to evaluate the feasibility, acceptability, and preliminary effectiveness of the culturally adapted one-day online CBT-based workshop among women with postpartum depressive symptoms in Türkiye. Sixty participants aged 18-45 years within the first postpartum year and with an Edinburgh Postnatal Depression Scale (EPDS) score ≥10 will be randomly assigned (1:1) to one of two groups: (1) a workshop group, who will receive the one-day online CBT-based workshop within the first month after enrollment; or (2) a control group, who will continue to receive usual postpartum care.
Eligible participants will be women aged 18-45 years who are within one year postpartum, have an EPDS score ≥10, are literate in Turkish, and have access to a stable internet connection. Exclusion criteria include current psychotic, bipolar, organic mental, or substance use disorders; a severe depressive episode requiring immediate clinical intervention; active suicidal ideation or intent; serious medical or neurological conditions that impair participation; or having an infant with a life-threatening congenital condition.
Assessments will be administered at baseline and at three months and will include the EPDS, Patient Health Questionnaire-9 (PHQ-9), Generalized Anxiety Disorder-7 (GAD-7), Frequency of Actions and Thoughts Scale (FATS), and the TÜRBAD Satisfaction Questionnaire (TÜRBAD-SQ). Although some Turkish validation studies suggest an EPDS cut-off of 12-13, a threshold of 10 was selected to align with international postpartum mental health research and to capture clinically relevant depressive symptoms.
Participants will be recruited through Marmara University clinical settings and community outreach channels.
Data collection and randomization will be conducted using REDCap (Research Electronic Data Capture) to ensure secure data management and methodological rigor. Findings from this pilot study will inform refinement of the intervention procedures, feasibility targets, and outcome measures, and will guide the development of a future large-scale randomized controlled trial.
- Conditions
- Postpartum Depression
- Being tested
- One-Day Online CBT-Based Workshop
- Keywords
- Cognitive Behavioral Therapy, Online Intervention, Cultural Adaptation, Women, Gender and Mental Health, Feasibility Study, Randomized Controlled Trial, Psychotherapy, Mood Disorders, Depressive Disorder, Behavioral Disciplines and Activities, Depression, Postpartum
- Medical subject headings
- Depression, Postpartum, Coitus, Psychological Well-Being, Mood Disorders, Depressive Disorder, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
One-Day Online CBT-Based WorkshopBehavioural
The online workshop is a culturally adapted, one-day group intervention designed for women experiencing postpartum depression in Türkiye. Adapted from a validated Canadian model, it is delivered online by trained facilitators and includes approximately six hours of instruction. The four-module program provides brief psychoeducation about postpartum depression, introduces core cognitive and behavioral skills (e.g., cognitive restructuring, problem-solving, behavioral activation, assertiveness), and concludes with goal setting and action planning. Teaching methods include short lectures, group discussions, and role-plays. Regular breaks are included, and each participant receives a Turkish-language booklet to support engagement.
| Study group | Role | What they receive |
|---|---|---|
| One-Day Online CBT-Based Workshop | Experimental | Participants in this arm will receive the culturally adapted one-day online CBT-based workshop within the first month after enrollment, in addition to standard postpartum care. Receives: Behavioral: One-Day Online CBT-Based Workshop |
| Control Usual Care | No intervention | Participants assigned to the control arm will continue to receive standard postnatal care from their healthcare providers. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment Feasibility (Number of Participants Enrolled)
The total number of participants successfully enrolled in the study will be recorded to assess recruitment feasibility. The target is to enroll 60 participants (30 intervention, 30 control) within six months.
Measured: 6 months
Proportion of Participants Completing All Study Questionnaires (EPDS, PHQ-9, GAD-7, FATS, TSQ)
This outcome will assess the proportion of participants who complete all required study questionnaires (EPDS, PHQ-9, GAD-7, FATS, and TÜRBAD-SQ) at both baseline and the 3-month follow-up. Completion will be calculated by dividing the number of participants who complete all instruments at both time points by the total number enrolled. The intervention will be considered feasible if at least 70% of participants complete all required questionnaires.
Measured: Baseline and 3 months
Retention Rate (Number of Participants Remaining at 3-Month Follow-up)
This outcome will measure the proportion of participants who remain enrolled in the study through the 3-month follow-up assessment. Retention will be calculated as the number of participants who complete the 3-month assessment divided by the number enrolled at baseline. Retention will be considered acceptable if at least 75% of participants remain in the study at the 3-month follow-up.
Measured: Baseline and 3 months
Intervention Adherence (Number of Participants Completing the Full One-Day Workshop)
This outcome will assess adherence to the one-day online CBT-based workshop among participants in the intervention group. The workshop consists of four modules delivered across a single day. Adherence will be defined as attending at least three of the four workshop modules. Adherence will be calculated as the number of participants meeting this criterion divided by the total number assigned to the intervention arm. The intervention will be considered feasible if at least 75% of participants meet the adherence threshold.
Measured: 1 day
Secondary outcomes (3)
Acceptability - TÜRBAD Satisfaction Questionnaire (TÜRBAD-SQ)
The 6-item TÜRBAD-SQ assesses participants' satisfaction with the one-day online workshop and the perceived feasibility of the intervention procedures. The first five items use "yes/no" response options to evaluate satisfaction and feasibility, while the sixth item is open-ended and allows participants to provide additional comments. Higher proportions of "yes" responses on the closed-ended items indicate greater acceptability. The intervention will be considered acceptable if at least 70% of participants endorse "yes" on the satisfaction-related items.
Measured: Immediately post-workshop and at 3-month follow-up
Cognitive and Behavioral Change - Frequency of Actions and Thoughts Scale (FATS)
The FATS is a 12-item self-report scale that measures the frequency of adaptive cognitive and behavioral skills commonly taught in Cognitive Behavioral Therapy (CBT), such as cognitive restructuring, behavioral activation, and problem solving. Items are rated on a Likert-type scale, and total scores reflect how often participants use these adaptive CBT-related thoughts and behaviors. Higher scores indicate greater use of CBT-based coping skills.
Measured: Baseline and 3 months
Preliminary Treatment Effect - Edinburgh Postnatal Depression Scale (EPDS)
Change in EPDS scores to estimate the preliminary effect on depressive symptoms. The EPDS is a 10-item self-report measure (0-30 total score); ≥13 indicates clinically significant symptoms, and a reduction >4 points is considered clinically meaningful.
Measured: Baseline and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2025
- Study startDec 2025 (estimated)
- Primary completion30 May 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postpartum DepressionStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned (1:1) to one of two parallel groups: (1) an intervention group receiving the culturally adapted one-day online CBT-based workshop, or (2) a control-usual care group.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Büşra Kalaça, Marmara University
- Investigators
- Büşra Kalaça, MD, Principal investigator, Marmara University, Department of PsychiatryAyşe Sakallı Kani, MD, Study director, Marmara University, Department of Psychiatry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07267702
- Sponsor's protocol ID
- 09.2025.118
- Status last verified
- Nov 2025
- First submitted
- 14 Nov 2025
- Last updated
- 5 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to institutional and ethical restrictions. Aggregate (summary) results will be made available in related publications and presentations.
Publications
Van Lieshout RJ, Layton H, Savoy CD, Brown JSL, Ferro MA, Streiner DL, Bieling PJ, Feller A, Hanna S. Effect of Online 1-Day Cognitive Behavioral Therapy-Based Workshops Plus Usual Care vs Usual Care Alone for Postpartum Depression: A Randomized Clinical Trial. JAMA Psychiatry. 2021 Nov 1;78(11):1200-1207. doi: 10.1001/jamapsychiatry.2021.2488.
PubMed 34495285
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cultural Adaptation of a One-Day Online Cognitive Behavioral Therapy Group Workshop for Postpartum Depression in Türkiye: A Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07267702
- Acronym / sponsor ID
- 09.2025.118
- Conditions
- Postpartum Depression
- Keywords
- Cognitive Behavioral Therapy, Online Intervention, Cultural Adaptation, Women, Gender and Mental Health, Feasibility Study, Randomized Controlled Trial, Psychotherapy, Mood Disorders
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- Dec 2025 (estimated)
- Primary completion
- 30 May 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 5 Dec 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.
This pilot randomized controlled trial aims to evaluate the feasibility, acceptability, and preliminary effects of a culturally adapted, one-day online Cognitive Behavioral Therapy (CBT)-based group workshop for women with postpartum depression in Türkiye. The intervention was adapted from a validated model developed in Ontario, Canada, using Bernal's cultural adaptation framework.
Participants will be randomly assigned in a 1:1 ratio to either a workshop group, who will receive the one-day online CBT-based workshop within the first month after enrollment, or a control group who will continue to receive usual postpartum care throughout the study period. Data will be collected at baseline and at the 3-month follow-up using the Edinburgh Postnatal Depression Scale (EPDS), Patient Health Questionnaire-9 (PHQ-9), Generalized Anxiety Disorder-7 (GAD-7), the Frequency of Actions and Thoughts Scale (FATS), and the TÜRBAD Satisfaction Questionnaire (TÜRBAD-SQ).
The study will assess feasibility indicators including recruitment, randomization procedures, completion of study questionnaires, retention through the 3-month follow-up, and adherence to the one-day workshop. Acceptability and preliminary changes in depressive, anxiety, and cognitive-behavioral outcomes will also be explored.
This pilot trial represents the first culturally adapted, one-day online CBT-based group intervention for postpartum depression in Türkiye and will inform the design of a future large-scale randomized controlled trial.
Detailed description
Postpartum depression (PPD) is a major public health concern affecting approximately one in five women worldwide and nearly one in five mothers in Türkiye. Despite its high prevalence, access to brief, evidence-based, and scalable psychological interventions remains limited, particularly in low- and middle-income settings. Untreated PPD increases the risk of chronic depression, impaired mother-infant bonding, and adverse emotional, behavioral, and developmental outcomes in children.
Cognitive Behavioral Therapy (CBT) is recommended as a first-line treatment for mild to moderate depression in the perinatal period; however, conventional CBT typically requires 12-15 weekly sessions, which can be difficult for new mothers due to caregiving demands, time limitations, and social isolation. Group-based interventions promote normalization and peer support but remain relatively inaccessible. Therefore, brief, structured, and scalable models are urgently needed.
A one-day CBT-based group workshop developed in Ontario, Canada has demonstrated feasibility, acceptability, and effectiveness in reducing postpartum depression. This study represents one of the first efforts to culturally adapt and evaluate this workshop for women in Türkiye. The adaptation followed Bernal's cultural adaptation framework to ensure conceptual, linguistic, and contextual relevance. All intervention materials were refined and finalized for pilot implementation following this adaptation phase.
This pilot randomized controlled trial aims to evaluate the feasibility, acceptability, and preliminary effectiveness of the culturally adapted one-day online CBT-based workshop among women with postpartum depressive symptoms in Türkiye. Sixty participants aged 18-45 years within the first postpartum year and with an Edinburgh Postnatal Depression Scale (EPDS) score ≥10 will be randomly assigned (1:1) to one of two groups: (1) a workshop group, who will receive the one-day online CBT-based workshop within the first month after enrollment; or (2) a control group, who will continue to receive usual postpartum care.
Eligible participants will be women aged 18-45 years who are within one year postpartum, have an EPDS score ≥10, are literate in Turkish, and have access to a stable internet connection. Exclusion criteria include current psychotic, bipolar, organic mental, or substance use disorders; a severe depressive episode requiring immediate clinical intervention; active suicidal ideation or intent; serious medical or neurological conditions that impair participation; or having an infant with a life-threatening congenital condition.
Assessments will be administered at baseline and at three months and will include the EPDS, Patient Health Questionnaire-9 (PHQ-9), Generalized Anxiety Disorder-7 (GAD-7), Frequency of Actions and Thoughts Scale (FATS), and the TÜRBAD Satisfaction Questionnaire (TÜRBAD-SQ). Although some Turkish validation studies suggest an EPDS cut-off of 12-13, a threshold of 10 was selected to align with international postpartum mental health research and to capture clinically relevant depressive symptoms.
Participants will be recruited through Marmara University clinical settings and community outreach channels.
Data collection and randomization will be conducted using REDCap (Research Electronic Data Capture) to ensure secure data management and methodological rigor. Findings from this pilot study will inform refinement of the intervention procedures, feasibility targets, and outcome measures, and will guide the development of a future large-scale randomized controlled trial.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned (1:1) to one of two parallel groups: (1) an intervention group receiving the culturally adapted one-day online CBT-based workshop, or (2) a control-usual care group.
| Arm | Type | Receives |
|---|---|---|
| One-Day Online CBT-Based Workshop | Experimental | Behavioral: One-Day Online CBT-Based WorkshopParticipants in this arm will receive the culturally adapted one-day online CBT-based workshop within the first month after enrollment, in addition to standard postpartum care. |
| Control Usual Care | No intervention | –Participants assigned to the control arm will continue to receive standard postnatal care from their healthcare providers. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Female participants aged 18-45 years
- Having an infant aged 1-12 months
- Presence of clinically relevant postpartum depressive symptoms (EPDS ≥10)
- Literate in Turkish (able to read and write)
- Access to a stable internet connection
Key exclusion criteria (5 listed)
- Current psychotic, bipolar, organic mental, or substance use disorder
- Severe depressive episode or impaired judgment due to psychiatric illness
- Active suicidal ideation or intent
- Medical or neurological condition preventing participation (e.g., dementia, intellectual disability, severe hearing or visual impairment)
- Infant with a life-threatening congenital disorder
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 |
|---|---|---|
| One-Day Online CBT-Based WorkshopThe online workshop is a culturally adapted, one-day group intervention designed for women experiencing postpartum depression in Türkiye. Adapted from a validated Canadian model, it is delivered online by trained facilitators and includes approximately six hours of instruction. The four-module program provides brief psychoeducation about postpartum depression, introduces core cognitive and behavioral skills (e.g., cognitive restructuring, problem-solving, behavioral activation, assertiveness), and concludes with goal setting and action planning. Teaching methods include short lectures, group discussions, and role-plays. Regular breaks are included, and each participant receives a Turkish-language booklet to support engagement. | Behavioural | One-Day Online CBT-Based Workshop |
Primary outcome
Recruitment Feasibility (Number of Participants Enrolled)
Time frame: 6 months
The total number of participants successfully enrolled in the study will be recorded to assess recruitment feasibility. The target is to enroll 60 participants (30 intervention, 30 control) within six months.
Proportion of Participants Completing All Study Questionnaires (EPDS, PHQ-9, GAD-7, FATS, TSQ)
Time frame: Baseline and 3 months
This outcome will assess the proportion of participants who complete all required study questionnaires (EPDS, PHQ-9, GAD-7, FATS, and TÜRBAD-SQ) at both baseline and the 3-month follow-up. Completion will be calculated by dividing the number of participants who complete all instruments at both time points by the total number enrolled. The intervention will be considered feasible if at least 70% of participants complete all required questionnaires.
Retention Rate (Number of Participants Remaining at 3-Month Follow-up)
Time frame: Baseline and 3 months
This outcome will measure the proportion of participants who remain enrolled in the study through the 3-month follow-up assessment. Retention will be calculated as the number of participants who complete the 3-month assessment divided by the number enrolled at baseline. Retention will be considered acceptable if at least 75% of participants remain in the study at the 3-month follow-up.
Intervention Adherence (Number of Participants Completing the Full One-Day Workshop)
Time frame: 1 day
This outcome will assess adherence to the one-day online CBT-based workshop among participants in the intervention group. The workshop consists of four modules delivered across a single day. Adherence will be defined as attending at least three of the four workshop modules. Adherence will be calculated as the number of participants meeting this criterion divided by the total number assigned to the intervention arm. The intervention will be considered feasible if at least 75% of participants meet the adherence threshold.
3 secondary outcomes
Acceptability - TÜRBAD Satisfaction Questionnaire (TÜRBAD-SQ)
Time frame: Immediately post-workshop and at 3-month follow-up
Cognitive and Behavioral Change - Frequency of Actions and Thoughts Scale (FATS)
Time frame: Baseline and 3 months
Preliminary Treatment Effect - Edinburgh Postnatal Depression Scale (EPDS)
Time frame: Baseline and 3 months
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 5 Dec 2025.
- Background: PubMed 34495285Van Lieshout RJ, Layton H, Savoy CD, Brown JSL, Ferro MA, Streiner DL, Bieling PJ, Feller A, Hanna S. Effect of Online 1-Day Cognitive Behavioral Therapy-Based Workshops Plus Usual Care vs Usual Care Alone for Postpartum Depression: A Randomized Clinical Trial. JAMA Psychiatry. 2021 Nov 1;78(11):1200-1207. doi: 10.1001/jamapsychiatry.2021.2488.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to institutional and ethical restrictions. Aggregate (summary) results will be made available in related publications and presentations.
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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.
Büşra Kalaça, MD principal investigator
Marmara University, Department of Psychiatry
Ayşe Sakallı Kani, MD study director
Marmara University, Department of Psychiatry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing One-Day Online CBT-Based Workshop in people with Postpartum Depression, run by Marmara University at 1 site in Turkey (Türkiye).
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 6 inclusion and 5 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: opening soon, as of the sponsor's last update on 5 Dec 2025. 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 Turkey (Türkiye). 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 Büşra Kalaça, MD (+90536 949 2031 ext. +90216 6254545, busraergut11@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment Feasibility (Number of Participants Enrolled) (time frame: 6 months). The study lists 4 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 NCT07267702, which also lists 1 linked publication.
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 5 Dec 2025.