Postpartum 1-Day CBT Pilot Study (Türkiye)

NCT ID: NCT07267702

Last Updated: 2025-12-05

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-31
• Study Completion Date: 2026-07-31

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

One-Day Online CBT-Based Workshop

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.

Group Type: EXPERIMENTAL

One-Day Online CBT-Based Workshop

Intervention Type: BEHAVIORAL

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.

Control Usual Care

Participants assigned to the control arm will continue to receive standard postnatal care from their healthcare providers.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

One-Day Online CBT-Based Workshop

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Marmara University

OTHER

Sponsor Role: lead

Responsible Party

Büşra Kalaça

Assistant Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Büşra Kalaça, MD

Role: PRINCIPAL_INVESTIGATOR

Marmara University, Department of Psychiatry

Ayşe Sakallı Kani, MD

Role: STUDY_DIRECTOR

Marmara University, Department of Psychiatry

Locations

Marmara University, Department of Psychiatry

Istanbul, Marmara, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Central Contacts

Büşra Kalaça, MD

Role: CONTACT

busraergut11@gmail.com

+90536 949 2031 ext. +90216 6254545

Ayşe Sakallı Kani, MD

Role: CONTACT

asakalli@marmara.edu.tr

+9505 814 9354 ext. +90216 6254545

Facility Contacts

Büşra Kalaça, MD

Role: primary

busraergut11@gmail.com

+90536 949 2031 ext. +90216 6254545

Ayşe Sakallı Kani, MD

Role: backup

asakalli@marmara.edu.tr

+9505 814 9354 ext. +90216 6254545

References

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.

Reference Type: BACKGROUND

PMID: 34495285 (View on PubMed)

Other Identifiers

09.2025.118

Identifier Type: -

Identifier Source: org_study_id