An interventional study of One-Day Online CBT-Based Workshop in Postpartum Depression, sponsored by Marmara University. Not yet recruiting at 1 site in Turkey (Türkiye). Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2025-12-05.
Sponsored by Marmara University · Not applicable, Interventional, and Other
Among 55 studies in Depression, Postpartum with a site in Turkey — 11 open to participants now, 12 under way, none of them phase 3. Depression, Postpartum · Turkey.
Among the 55 studies in Depression, Postpartum with a site in Turkey, this one is the 35th largest by planned enrollment of the 43 interventional ones, is one of 9 that started in 2025, is one of 43 with no phase, reaches primary completion later than 3 of the 11 other live ones, and was the 41st registered.
569 studies on the registry are indexed under Depression, Postpartum; 134 are open to participants now.
This study's planned enrollment of 60 is below the median of 104 across 454 interventional studies indexed under Depression, Postpartum.
Browse Depression, Postpartum studies →11 of the 55 studies in Depression, Postpartum with a site in Turkey are open now, in 1 country. Each count lists the studies.
Of the 86 Depression, Postpartum studies recruiting now, 54 (63%) set no upper age limit and 29 (34%) stop at 75 or younger; 13 take children under 18; 40 take healthy volunteers.
This study: 18 Years to 45 Years · female · no healthy volunteers.
The full table on the hub →55 studies; the count open now beside each. This study's row is marked.
First in 2016; this study’s year is marked. 9 started in 2025.
Median enrollment 88 across the 43 interventional studies, 99 across the 12 observational. Of the 38 that completed or were terminated, 0 (0%) have results posted.
None of the 55 has an industry lead sponsor. The 10 most frequent:
Marmara University is the lead sponsor of 599 studies on the registry; 138 are open to participants now.
Marmara University has 3 studies filed under Depression, Postpartum — fewer than ten, so there is no comparison to draw.
4 of the studies in Depression, Postpartum with a site in Turkey that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07354334Selcuk UniversityEffect of Listening to Surah Al-Inshirah (The Opening-Up of the Heart) After Cesarean Birth on Postpartum Outcomes | 2026-12 |
| NCT07370025Istanbul University - CerrahpasaThe Effect of Lullaby During Bath Time on Mother-Infant Bonding, Postpartum Depression, and Parental Self-Efficacy in Infants | 2026-12-15 |
| NCT07396415Marmara UniversityTelehealth-Supported Breastfeeding Counseling in Primiparous Mothers | 2027-01-25 |
| NCT07887178Istanbul University - CerrahpasaMethyl Donor-Rich Diet in the Postpartum Period | 2027-10 |
Among the 55 studies in Depression, Postpartum with a site in Turkey, from their registry updates:
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Behavioral: One-Day Online CBT-Based Workshop
Participants assigned to the control arm will continue to receive standard postnatal care from their healthcare providers.
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 1 day
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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline and 3 months
Plan to share: 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.
Start is estimated for Dec 2025; primary completion for May 2026, 5 months later.
Of 256 non-industry interventional studies with no phase under Depression, Postpartum, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 36. This study's planned 5 months is below that.
Counting every sponsor, half of 262 studies reached it within 23 months; a quarter within 11 and three quarters within 36.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.
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