Postpartum DepressionNCT07062159
Psychoeducational Intervention to Reduce Depressive Symptoms and Strengthen Mother-Infant Bonding
A study testing the psychoeducation intervention program and routine care in people with Postpartum Depression and Psychoeducation, run by Yasemin Ozhuner at 1 site in Turkey (Türkiye).
Trial summary
The study aims to evaluate the effectiveness of a psychoeducational intervention designed within the framework of the Watson Human Caring Model in reducing postpartum depressive symptoms and creating a stronger mother-infant bond. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postpartum Depression, Psychoeducation, Mother-Infant Interaction
- What is being tested?
- the psychoeducation intervention program and routine care
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 88 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Jul 2025to 5 Jan 2026
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- • Women in their 20-35th week of pregnancy,
- Volunteers,
- Over 18 years of age,
- Literate,
- No visual, hearing or mental disabilities,
- Having a healthy baby weighing over 2500 grams,
- Being in the same environment with their baby after birth,
- Having a healthy fetus on ultrasound will be included in the study.
Who cannot join
- • Those diagnosed with depression or other mental illnesses by a physician,
- Those taking medication for mental illness,
- Women who have given birth prematurely,
- Stillbirth,
- Those who have not participated in more than one interview will not be included in the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Eskisehir Osmangazi University
Eskişehir, Odunpazarı, 26000
About this study
Official title: Effectiveness of Psychoeducational Intervention in Reducing Postpartum Depressive Symptoms and Strengthening Mother-Infant Bonding: A Randomized Controlled Trial From the Watson Model Perspective
The study aims to evaluate the effectiveness of a psychoeducational intervention designed within the framework of the Watson Human Caring Model in reducing postpartum depressive symptoms and creating a stronger mother-infant bond. Specifically, it aims to investigate whether a person-centered approach based on the principles of Watson's caring science can significantly increase the psychological well-being of postpartum mothers and improve the quality of their relationship with their babies.
Read the detailed description
The pregnant women included in the sample were informed about the study and their written consent was obtained. Six interviews were conducted with the pregnant women, four at one-week intervals before birth and one on the seventh day and fourth week after birth. These interviews were conducted with the women one-on-one and face-to-face. The women in the control group did not receive any treatment other than routine care at family health centers. The psychoeducation program was applied to the women in the intervention group in six interviews.
- Being tested
- the psychoeducation intervention program, routine care
- Keywords
- Postpartum Depression, Watson model, psychoeducation, Mother-Infant Interaction
- Medical subject headings
- Depression, Postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the psychoeducation intervention programOther
The content of the psychoeducation intervention program based on the Watson Human Caring Model will consist of the postpartum process and care, maternal blues, postpartum psychosis, postpartum depression, frequency, causes, predisposing factors, symptoms, effects on mother, child and community health, diagnosis and treatment, preventive practices, social support, adaptation to the role of motherhood, mother and baby bonding, practices that will strengthen mother-baby bonding, breast milk and breastfeeding, nutrition and baby care, problems encountered in baby care and solution suggestions.
routine careOther
routine care
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Active comparator | Active Comparator: intervention group The pregnant women in the sample were informed about the study and their written consent was obtained. A total of six interviews were conducted with the pregnant women, four at one-week intervals before birth and one interview on the seventh day and fourth week after birth. These interviews were conducted with the women one-on-one and face-to-face. The psychoeducation program was applied to the women in the intervention group in six interviews. In the first interview, the women were given a booklet of the psychoeducation intervention program based on the Watson Human Caring Model for postpartum care and the interview was conducted within the scope of the program. The psychoeducation intervention program interviews based on the Watson Human Caring Model in the study were conducted according to the Watson Human Caring Model improvement processes and psychoeducation techniques. The interviews lasted between 60-90 minutes on average. Receives: Other: the psychoeducation intervention program |
| control group | Placebo comparator | Placebo Comparator: Control Group The pregnant women in the sample were informed about the study and their written consent was obtained. Six interviews were conducted with the pregnant women, four at one-week intervals before delivery and once on the seventh day and fourth week after delivery. These interviews were conducted with the women one-on-one and face-to-face. The women in the control group did not receive any treatment other than their routine care at family health centers. In routine care, pregnant women were examined for edema, varicose veins, weight, blood pressure, pulse, laboratory findings, baby heart sounds, medication intake, chronic disease follow-up and vaccination. Pregnant women were provided with counseling if they had any questions. After delivery, women were provided with medication intake, blood pressure, fever, pulse, bleeding and laboratory findings and counseling if they had any questions. Receives: Other: routine care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prenatal Attachment Scale
Prenatal Attachment Scale The scale consists of 21 items in total. The highest score on the scale is 84, the lowest score is 21, and the increase in the total score obtained from the scale indicates that prenatal attachment is positive.
Measured: 1 day (first meeting during pregnancy)
Edinburgh Postpartum Depression Scale
It is a 10-item self-report scale that measures maternal depressive symptoms over the past seven days. Higher scores reflect more depressive symptoms. Symptoms are rated on a 4-point Likert scale with scores ranging from 0 to 30. The cut-off score of the scale was determined as ≥13. If the total score of the scale is 12 or less, the participant is not at risk for PPD, but if he scores 13 or more, he is at risk.
Measured: 1 day (first meeting during pregnancy and at the fourth week postpartum)
Mother-Infant Attachment Scale
Mother-Infant Attachment Scale This scale, which is used from the first day after birth, allows the mother to describe her feelings towards her baby in one word. The lowest score that can be obtained from the scale is 0 and the highest score is 24. As the score increases, attachment is negatively affected.
Measured: fourth week postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2025
- Study start2 Jul 2025
- Primary completion19 Aug 2025
- Study completion5 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postpartum DepressionStudies 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
- The pregnant women included in the sample were informed about the study and their written consent was obtained. Six interviews were conducted with the pregnant women, four at one-week intervals before birth and one on the seventh day and fourth week after birth. These interviews were conducted with the women one-on-one and face-to-face. The women in the control group did not receive any treatment other than routine care at family health centers. The psychoeducation program was administered to the women in the intervention group in six interviews.
- Masking
- None (open label)
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yasemin Ozhuner
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yasemin Ozhuner, Eskisehir Osmangazi University
- Investigators
- Yasemin Özhüner, Principal investigator, Eskişehir Vadişehir Family center odunpazarı TurkeyNebahat Ozerdogan, Study director, Eskisehir Osmangazi University odunpazarı turkey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07062159
- Sponsor's protocol ID
- Attachment and depression
- Status last verified
- Jan 2026
- First submitted
- 2 Jul 2025
- Last updated
- 7 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Psychoeducational Intervention in Reducing Postpartum Depressive Symptoms and Strengthening Mother-Infant Bonding: A Randomized Controlled Trial From the Watson Model Perspective
- ClinicalTrials.gov ID
- NCT07062159
- Acronym / sponsor ID
- Attachment and depression
- Keywords
- Postpartum Depression, Watson model, psychoeducation, Mother-Infant Interaction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Yasemin OzhunerUniversity, hospital or other
- Study start
- 2 Jul 2025 (actual)
- Primary completion
- 19 Aug 2025 (actual)
- Study completion
- 5 Jan 2026 (actual)
- First posted
- 14 Jul 2025 (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.
The study aims to evaluate the effectiveness of a psychoeducational intervention designed within the framework of the Watson Human Caring Model in reducing postpartum depressive symptoms and creating a stronger mother-infant bond. Specifically, it aims to investigate whether a person-centered approach based on the principles of Watson's caring science can significantly increase the psychological well-being of postpartum mothers and improve the quality of their relationship with their babies.
Detailed description
The pregnant women included in the sample were informed about the study and their written consent was obtained. Six interviews were conducted with the pregnant women, four at one-week intervals before birth and one on the seventh day and fourth week after birth. These interviews were conducted with the women one-on-one and face-to-face. The women in the control group did not receive any treatment other than routine care at family health centers. The psychoeducation program was applied to the women in the intervention group in six interviews.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The pregnant women included in the sample were informed about the study and their written consent was obtained. Six interviews were conducted with the pregnant women, four at one-week intervals before birth and one on the seventh day and fourth week after birth. These interviews were conducted with the women one-on-one and face-to-face. The women in the control group did not receive any treatment other than routine care at family health centers. The psychoeducation program was administered to the women in the intervention group in six interviews.
| Arm | Type | Receives |
|---|---|---|
| intervention group | Active comparator | Other: the psychoeducation intervention programActive Comparator: intervention group The pregnant women in the sample were informed about the study and their written consent was obtained. A total of six interviews were conducted with the pregnant women, four at one-week intervals before birth and one interview on the seventh day and fourth week after birth. These interviews were conducted with the women one-on-one and face-to-face. The psychoeducation program was applied to the women in the intervention group in six interviews. In the first interview, the women were given a booklet of the psychoeducation intervention program based on the Watson Human Caring Model for postpartum care and the interview was conducted within the scope of the program. The psychoeducation intervention program interviews based on the Watson Human Caring Model in the study were conducted according to the Watson Human Caring Model improvement processes and psychoeducation techniques. The interviews lasted between 60-90 minutes on average. |
| control group | Placebo comparator | Other: routine carePlacebo Comparator: Control Group The pregnant women in the sample were informed about the study and their written consent was obtained. Six interviews were conducted with the pregnant women, four at one-week intervals before delivery and once on the seventh day and fourth week after delivery. These interviews were conducted with the women one-on-one and face-to-face. The women in the control group did not receive any treatment other than their routine care at family health centers. In routine care, pregnant women were examined for edema, varicose veins, weight, blood pressure, pulse, laboratory findings, baby heart sounds, medication intake, chronic disease follow-up and vaccination. Pregnant women were provided with counseling if they had any questions. After delivery, women were provided with medication intake, blood pressure, fever, pulse, bleeding and laboratory findings and counseling if they had any questions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- • Women in their 20-35th week of pregnancy,
Key exclusion criteria (5 listed)
- • Those diagnosed with depression or other mental illnesses by a physician,
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 |
|---|---|---|
| the psychoeducation intervention programThe content of the psychoeducation intervention program based on the Watson Human Caring Model will consist of the postpartum process and care, maternal blues, postpartum psychosis, postpartum depression, frequency, causes, predisposing factors, symptoms, effects on mother, child and community health, diagnosis and treatment, preventive practices, social support, adaptation to the role of motherhood, mother and baby bonding, practices that will strengthen mother-baby bonding, breast milk and breastfeeding, nutrition and baby care, problems encountered in baby care and solution suggestions. | Other | intervention group |
| routine careroutine care | Other | control group |
Primary outcome
Prenatal Attachment Scale
Time frame: 1 day (first meeting during pregnancy)
Prenatal Attachment Scale The scale consists of 21 items in total. The highest score on the scale is 84, the lowest score is 21, and the increase in the total score obtained from the scale indicates that prenatal attachment is positive.
Edinburgh Postpartum Depression Scale
Time frame: 1 day (first meeting during pregnancy and at the fourth week postpartum)
It is a 10-item self-report scale that measures maternal depressive symptoms over the past seven days. Higher scores reflect more depressive symptoms. Symptoms are rated on a 4-point Likert scale with scores ranging from 0 to 30. The cut-off score of the scale was determined as ≥13. If the total score of the scale is 12 or less, the participant is not at risk for PPD, but if he scores 13 or more, he is at risk.
Mother-Infant Attachment Scale
Time frame: fourth week postpartum
Mother-Infant Attachment Scale This scale, which is used from the first day after birth, allows the mother to describe her feelings towards her baby in one word. The lowest score that can be obtained from the scale is 0 and the highest score is 24. As the score increases, attachment is negatively affected.
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 7 Jan 2026.
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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.
Yasemin Özhüner principal investigator
Eskişehir Vadişehir Family center odunpazarı Turkey
Nebahat Ozerdogan study director
Eskisehir Osmangazi University odunpazarı turkey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing the psychoeducation intervention program and routine care in people with Postpartum Depression and Psychoeducation, run by Yasemin Ozhuner 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 8 inclusion and 5 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 7 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. Some participants in this study may receive a placebo. 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?
Prenatal Attachment Scale (time frame: 1 day (first meeting during pregnancy)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Jan 2026.