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Clinical Trials/NCT07267702
NCT07267702Not yet recruitingNot Applicable

Cultural Adaptation of a One-Day Online Cognitive Behavioral Therapy Group Workshop for Postpartum Depression in Türkiye: A Pilot Randomized Controlled Trial

Marmara University2 sites in 1 country60 target enrollmentStarted: December 1, 2025Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
60
Locations
2
Primary Endpoint
Recruitment Feasibility (Number of Participants Enrolled)

Study Overview

Brief 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. 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Other
Masking
None

Masking Description

This is an open-label pilot randomized controlled trial. Participants and facilitators cannot be blinded due to the nature of the behavioral intervention. However, outcome assessors and data analysts will remain blinded to group assignment to reduce potential assessment and analysis bias.

Eligibility Criteria

Ages
18 Years to 45 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Acceptability - TÜRBAD Satisfaction Questionnaire (TÜRBAD-SQ)(Immediately post-workshop and at 3-month follow-up)
  • Cognitive and Behavioral Change - Frequency of Actions and Thoughts Scale (FATS)(Baseline and 3 months)
  • Acceptability - TÜRBAD Satisfaction Questionnaire (TÜRBAD-SQ)(Immediately post-workshop and at 3-month follow-up)
  • Cognitive and Behavioral Change - Frequency of Actions and Thoughts Scale (FATS)(Baseline and 3 months)
  • Preliminary Treatment Effect - Edinburgh Postnatal Depression Scale (EPDS)(Baseline and 3 months)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Büşra Kalaça

Assistant Doctor

Marmara University

Study Sites (2)

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