Postpartum Depression (PPD)TIPPDPNCT07329270
A Trauma-Informed Primary Health Care Intervention to Prevent Postpartum Depression After Disaster
A study testing Trauma-Informed Preventive Intervention in people with Postpartum Depression (PPD), run by Istanbul Bilgi University at 1 site in Turkey (Türkiye).
Trial summary
Postpartum depression is a common mental health problem that can affect women after childbirth and may have long-lasting consequences for both mothers and infants. The risk of postpartum depression is substantially higher in disaster-affected regions due to exposure to trauma, loss, displacement, disruption of health… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Postpartum Depression (PPD)
- What is being tested?
- Trauma-Informed Preventive Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2024to 30 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Postpartum women aged 18 years or older
- Having an infant younger than 60 days at the time of enrollment
- Living in earthquake-affected regions of Türkiye
- Receiving routine postpartum follow-up through primary health care services
- Able to communicate in Turkish
- Provided written informed consent
Who cannot join
- History of a diagnosed psychiatric disorder prior to the current postpartum period
- Severe medical conditions requiring specialized care
- Cognitive impairment or any con
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Narlıca 2 No'lu Family Physician Center
Hatay, Antakya
About this study
Official title: Postpartum Depression Prevention Program in Disaster-Affected Regions
Postpartum depression is a common mental health problem that can affect women after childbirth and may have long-lasting consequences for both mothers and infants. The risk of postpartum depression is substantially higher in disaster-affected regions due to exposure to trauma, loss, displacement, disruption of health services, and ongoing psychosocial stressors.
This study aimed to develop and evaluate a trauma-informed postpartum depression prevention program for women living in earthquake-affected regions of Türkiye using a sequential mixed-methods design. In the first phase, the program was developed based on qualitative findings obtained through in-depth interviews with postpartum women. In the second phase, the effectiveness of the newly developed program was tested using an experimental design.
Read more
During the qualitative phase, in-depth interviews were conducted with 24 postpartum women, and data were analyzed using interpretative phenomenological analysis (IPA) to explore women's lived experiences, perceived needs, and priorities related to mental health and psychosocial support after childbirth in a disaster context. The findings from this phase informed the content, structure, and delivery of the trauma-informed prevention program.
In the quantitative phase, the program was evaluated through a randomized controlled trial. Eligible postpartum women were randomly assigned either to the trauma-informed prevention program or to a comparison group receiving usual primary health care services. Postpartum depressive symptoms were assessed using validated measures.
The primary objective of the study was to evaluate the effectiveness of the trauma-informed program in reducing postpartum depressive symptoms. The findings are expected to contribute to evidence-based, trauma-informed approaches for preventing postpartum depression in disaster-affected settings.
Read the detailed description
Women living in disaster-affected regions face increased vulnerability to postpartum depression due to exposure to traumatic events, loss of social and material resources, disruptions in health care delivery, and prolonged uncertainty. Addressing postpartum mental health in such contexts requires interventions that are both evidence-based and responsive to women's lived experiences.
This study employed a sequential mixed-methods design to develop and evaluate a trauma-informed postpartum depression prevention program for women living in earthquake-affected regions of Türkiye. The study consisted of two consecutive phases: a qualitative program development phase and a quantitative experimental evaluation phase.
In the first phase, the trauma-informed postpartum depression prevention program was developed by the research team based on qualitative data collected from 24 postpartum women. In-depth, semi-structured interviews were conducted to explore participants' lived experiences of the postpartum period in a disaster context, perceived psychosocial needs, sources of distress and support, and expectations from health care services. The qualitative data were analyzed using interpretative phenomenological analysis (IPA), allowing for an in-depth understanding of participants' subjective experiences and meaning-making processes. The findings from this phase directly informed the content, focus, and delivery strategies of the intervention.
In the second phase, the effectiveness of the newly developed program was evaluated using an experimental design. Eligible postpartum women were recruited through primary health care services and randomly assigned to either the intervention group, which received the trauma-informed postpartum depression prevention program, or a comparison group receiving usual postpartum care. The intervention was delivered within routine primary health care settings by trained health care professionals.
The primary outcome of the study was postpartum depressive symptoms, assessed using validated screening instruments at predefined follow-up points. Secondary outcomes included measures of perceived social support, stress and coping perception. Data collection and outcome assessments were conducted in accordance with the study protocol.
By combining qualitative insights from postpartum women with rigorous experimental testing, this study aimed to generate robust evidence on the development and effectiveness of trauma-informed preventive interventions for postpartum depression in disaster-affected settings. The findings are intended to inform maternal mental health practice, program development, and public health policy in disaster and post-disaster contexts.
- Conditions
- Postpartum Depression (PPD)
- Being tested
- Trauma-Informed Preventive Intervention
- Keywords
- postpartum depression | trauma-informed care | disaster response | maternal mental health | primary health care | resilience | Türkiye earthquakes
- Medical subject headings
- Depression, Postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trauma-Informed Preventive InterventionBehavioural
This is a newly developed trauma-informed postpartum depression prevention program designed for women living in earthquake-affected regions. The program was developed by the research team based on qualitative findings from in-depth interviews with postpartum women analyzed using interpretative phenomenological analysis. It was delivered within primary health care settings by trained health care professionals and included psychoeducation, emotional support, coping skills enhancement, and facilitation of social support and referral when needed.
| Study group | Role | What they receive |
|---|---|---|
| Trauma-Informed Postpartum Depression Prevention Program | Experimental | Participants in this arm received a trauma-informed postpartum depression prevention program developed by the research team. The program was informed by findings from an initial qualitative phase using interpretative phenomenological analysis and was integrated into routine primary health care services in earthquake-affected regions. The intervention focused on early identification of psychological distress, psychoeducation, emotional support, strengthening coping skills, and enhancing social support. Receives: Behavioral: Trauma-Informed Preventive Intervention |
| No Intervention / Usual Care | No intervention | Participants in this arm received usual postpartum care provided through routine primary health care services without a structured trauma-informed mental health prevention component. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postpartum Depressive Symptoms
Postpartum depressive symptoms were assessed using the Edinburgh Postnatal Depression Scale (EPDS), a validated 10-item self-report instrument widely used for screening depressive symptoms during the postpartum period. Higher scores indicate greater severity of depressive symptoms. The primary outcome was the change in EPDS scores from baseline to six months post-intervention.
Measured: Baseline and at infant age 6 months.
Secondary outcomes (1)
Perceived Stress
Perceived stress was assessed using a self-report item asking participants how often they felt stressed during the past week, rated on a five-point scale ranging from "never" to "very often." Higher scores indicate higher perceived stress levels.
Measured: Baseline and at infant age 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2026
- Study start1 Nov 2024
- Primary completion1 Jul 2025
- Study completion30 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postpartum Depression (PPD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were assigned in parallel to either a trauma-informed postpartum depression prevention program or to usual postpartum care. The intervention was developed using findings from an initial qualitative phase and evaluated using an experimental design.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Bilgi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zeynep Şimşek, Istanbul Bilgi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07329270
- Sponsor's protocol ID
- BAP-2023.02.002
- Other IDs
- TUBİTAK424K188
- Acronym
- TIPPDP
- Status last verified
- Dec 2025
- First submitted
- 29 Dec 2025
- Last updated
- 9 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The dataset includes sensitive mental health information collected from postpartum women living in disaster-affected regions, and data sharing is restricted due to ethical and confidentiality considerations.
Publications
Manuscript under peer review.
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postpartum Depression Prevention Program in Disaster-Affected Regions
- ClinicalTrials.gov ID
- NCT07329270
- Acronym / sponsor ID
- TIPPDP / BAP-2023.02.002
- Conditions
- Postpartum Depression (PPD)
- Keywords
- postpartum depression | trauma-informed care | disaster response | maternal mental health | primary health care | resilience | Türkiye earthquakes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Istanbul Bilgi UniversityUniversity, hospital or other
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 1 Jul 2025 (actual)
- Study completion
- 30 Jul 2025 (actual)
- First posted
- 9 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Postpartum depression is a common mental health problem that can affect women after childbirth and may have long-lasting consequences for both mothers and infants. The risk of postpartum depression is substantially higher in disaster-affected regions due to exposure to trauma, loss, displacement, disruption of health services, and ongoing psychosocial stressors.
This study aimed to develop and evaluate a trauma-informed postpartum depression prevention program for women living in earthquake-affected regions of Türkiye using a sequential mixed-methods design. In the first phase, the program was developed based on qualitative findings obtained through in-depth interviews with postpartum women. In the second phase, the effectiveness of the newly developed program was tested using an experimental design.
During the qualitative phase, in-depth interviews were conducted with 24 postpartum women, and data were analyzed using interpretative phenomenological analysis (IPA) to explore women's lived experiences, perceived needs, and priorities related to mental health and psychosocial support after childbirth in a disaster context. The findings from this phase informed the content, structure, and delivery of the trauma-informed prevention program.
In the quantitative phase, the program was evaluated through a randomized controlled trial. Eligible postpartum women were randomly assigned either to the trauma-informed prevention program or to a comparison group receiving usual primary health care services. Postpartum depressive symptoms were assessed using validated measures.
The primary objective of the study was to evaluate the effectiveness of the trauma-informed program in reducing postpartum depressive symptoms. The findings are expected to contribute to evidence-based, trauma-informed approaches for preventing postpartum depression in disaster-affected settings.
Detailed description
Women living in disaster-affected regions face increased vulnerability to postpartum depression due to exposure to traumatic events, loss of social and material resources, disruptions in health care delivery, and prolonged uncertainty. Addressing postpartum mental health in such contexts requires interventions that are both evidence-based and responsive to women's lived experiences.
This study employed a sequential mixed-methods design to develop and evaluate a trauma-informed postpartum depression prevention program for women living in earthquake-affected regions of Türkiye. The study consisted of two consecutive phases: a qualitative program development phase and a quantitative experimental evaluation phase.
In the first phase, the trauma-informed postpartum depression prevention program was developed by the research team based on qualitative data collected from 24 postpartum women. In-depth, semi-structured interviews were conducted to explore participants' lived experiences of the postpartum period in a disaster context, perceived psychosocial needs, sources of distress and support, and expectations from health care services. The qualitative data were analyzed using interpretative phenomenological analysis (IPA), allowing for an in-depth understanding of participants' subjective experiences and meaning-making processes. The findings from this phase directly informed the content, focus, and delivery strategies of the intervention.
In the second phase, the effectiveness of the newly developed program was evaluated using an experimental design. Eligible postpartum women were recruited through primary health care services and randomly assigned to either the intervention group, which received the trauma-informed postpartum depression prevention program, or a comparison group receiving usual postpartum care. The intervention was delivered within routine primary health care settings by trained health care professionals.
The primary outcome of the study was postpartum depressive symptoms, assessed using validated screening instruments at predefined follow-up points. Secondary outcomes included measures of perceived social support, stress and coping perception. Data collection and outcome assessments were conducted in accordance with the study protocol.
By combining qualitative insights from postpartum women with rigorous experimental testing, this study aimed to generate robust evidence on the development and effectiveness of trauma-informed preventive interventions for postpartum depression in disaster-affected settings. The findings are intended to inform maternal mental health practice, program development, and public health policy in disaster and post-disaster contexts.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Participants were assigned in parallel to either a trauma-informed postpartum depression prevention program or to usual postpartum care. The intervention was developed using findings from an initial qualitative phase and evaluated using an experimental design.
| Arm | Type | Receives |
|---|---|---|
| Trauma-Informed Postpartum Depression Prevention Program | Experimental | Behavioral: Trauma-Informed Preventive InterventionParticipants in this arm received a trauma-informed postpartum depression prevention program developed by the research team. The program was informed by findings from an initial qualitative phase using interpretative phenomenological analysis and was integrated into routine primary health care services in earthquake-affected regions. The intervention focused on early identification of psychological distress, psychoeducation, emotional support, strengthening coping skills, and enhancing social support. |
| No Intervention / Usual Care | No intervention | –Participants in this arm received usual postpartum care provided through routine primary health care services without a structured trauma-informed mental health prevention component. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Postpartum women aged 18 years or older
- Having an infant younger than 60 days at the time of enrollment
- Living in earthquake-affected regions of Türkiye
- Receiving routine postpartum follow-up through primary health care services
- Able to communicate in Turkish
Key exclusion criteria (3 listed)
- History of a diagnosed psychiatric disorder prior to the current postpartum period
- Severe medical conditions requiring specialized care
- Cognitive impairment or any con
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trauma-Informed Preventive InterventionThis is a newly developed trauma-informed postpartum depression prevention program designed for women living in earthquake-affected regions. The program was developed by the research team based on qualitative findings from in-depth interviews with postpartum women analyzed using interpretative phenomenological analysis. It was delivered within primary health care settings by trained health care professionals and included psychoeducation, emotional support, coping skills enhancement, and facilitation of social support and referral when needed. | Behavioural | Trauma-Informed Postpartum Depression Prevention Program |
Primary outcome
Postpartum Depressive Symptoms
Time frame: Baseline and at infant age 6 months.
Postpartum depressive symptoms were assessed using the Edinburgh Postnatal Depression Scale (EPDS), a validated 10-item self-report instrument widely used for screening depressive symptoms during the postpartum period. Higher scores indicate greater severity of depressive symptoms. The primary outcome was the change in EPDS scores from baseline to six months post-intervention.
1 secondary outcome
Perceived Stress
Time frame: Baseline and at infant age 6 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2026.
- BackgroundManuscript under peer review.
- Individual participant dataSharing planned: No. The dataset includes sensitive mental health information collected from postpartum women living in disaster-affected regions, and data sharing is restricted due to ethical and confidentiality considerations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trauma-Informed Preventive Intervention in people with Postpartum Depression (PPD), run by Istanbul Bilgi University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postpartum Depressive Symptoms (time frame: Baseline and at infant age 6 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07329270, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2026.