Postpartum 1-Day CBT Pilot Study (Türkiye)
ConditionPostpartum Depression
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorMarmara University
About this 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).
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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)
Trial design
Design model
Parallel
Treatments tested in this trial
One-Day Online CBT-Based Workshop
BehavioralThe 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.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: One-Day Online CBT-Based WorkshopExperimental treatment 1 intervention
Group B: Control Usual CareNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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 months2
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 months3
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 months4
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 daySecondary outcomes
1
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-up2
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 months3
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 monthsSponsors and contacts
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Source ClinicalTrials.gov
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