Postpartum 1-Day CBT Pilot Study (Türkiye)

NCT07267702 | Not Yet Recruiting

• 1 other identifier: 09.2025.118
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Postpartum Depression

Keywords

Cognitive Behavioral Therapy; Online Intervention; Cultural Adaptation; Women, Gender and Mental Health; Feasibility Study; Randomized Controlled Trial; Psychotherapy; Mood Disorders; Depressive Disorder; Behavioral Disciplines and Activities; Depression, Postpartum

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  1 day

Secondary Outcomes (3)

• 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

Study Arms (2)

One-Day Online CBT-Based Workshop

EXPERIMENTAL

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

Control Usual Care

NO INTERVENTION

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

Interventions

One-Day Online CBT-Based Workshop 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.

One-Day Online CBT-Based Workshop

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Marmara University, Department of Psychiatry

Istanbul, Marmara, 34854, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 34495285 BACKGROUND

MeSH Terms

Conditions

Depression, Postpartum; Coitus; Psychological Well-Being; Mood Disorders; Depressive Disorder; Motor Activity

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Mental Disorders; Sexual Behavior; Behavior; Personal Satisfaction

Study Officials

• Büşra Kalaça, MD

  Marmara University, Department of Psychiatry

  PRINCIPAL INVESTIGATOR

• Ayşe Sakallı Kani, MD

  Marmara University, Department of Psychiatry

  STUDY DIRECTOR

Central Study Contacts

Büşra Kalaça, MD

CONTACT

+90536 949 2031; busraergut11@gmail.com

Ayşe Sakallı Kani, MD

CONTACT

+9505 814 9354; asakalli@marmara.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Doctor

Model Details: Participants will be randomly assigned (1:1) to one of two parallel groups: (1) an intervention group receiving the culturally adapted one-day online CBT-based workshop, or (2) a control-usual care group.

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: December 5, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: December 5, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)