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Postpartum 1-Day CBT Pilot Study (Türkiye)

Sponsored by Marmara University

About this trial

Last updated 6 months ago

Study ID

09.2025.118

Status

Not yet recruiting

Type

Interventional

Phase

N/A

Placebo

No

Accepting

18 to 45 Years
Female

Trial Timing

Started 7 months ago

What is this trial about?

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.

What are the participation requirements?

Inclusion Criteria

* 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

Exclusion Criteria

* 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