NCT06787300

Brief Summary

Postpartum depression is a condition that occurs after birth and is difficult for mothers. Research shows that experiencing postpartum depression once increases the risk of experiencing it in subsequent pregnancies. At the same time, there are findings in the literature that pregnant women with postpartum depression experience mental difficulties, anxiety or depression during pregnancy. For this reason, this study aims to determine the risk of postpartum depression in pregnant women who are pregnant for the first time during pregnancy and to prevent this risk from occurring in the postpartum period. For this purpose, 'Stories to empower mothers' programme was created. This programme was created by researchers who are specialist psychiatric nurses, psychotherapists and art therapists and finalised with expert opinions. The programme consists of six sessions. The sessions are individual and are conducted online except for the first session. A storybook is formed at the end of the programme with the steps followed during the sessions. While creating this storybook, the themes of self-knowledge, defining the situation, identifying difficulties, identifying sources of help, discovering strengths and creating new coping strategies are addressed by using art therapy techniques. The aim of the study is to examine the effect of the 'Stories Empowering Mothers Programme' on the risk of postpartum depression in pregnant women experiencing their first pregnancy. The research is conducted in a non-randomised experimental follow-up research design. Pregnant women who meet the inclusion criteria of the study can be included in the experimental or control group according to their wishes. The data collection process in the study proceeds in the order of determining the target group, pre-test (24-32nd gestational week), post-test (after 5 weeks), follow-up one test (postpartum 2nd-4th week) and follow-up two tests (postpartum 10th-12th week). The data are obtained with the Case Report Form and Postpartum Information Form prepared by the researcher and EPDI, BDI and Brief Psychological Resilience Scale forms. Expert support will be obtained for statistical analyses. Ethics committee permission was obtained before the research was started to be conducted. The research is a doctoral thesis supported by TÜBİTAK.

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2021

Completed
3.8 years until next milestone

First Submitted

Initial submission to the registry

January 11, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 22, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 10, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 2, 2025

Completed
Last Updated

January 22, 2025

Status Verified

January 1, 2025

Enrollment Period

4.2 years

First QC Date

January 11, 2025

Last Update Submit

January 18, 2025

Conditions

Keywords

postpartum depressionpschiatric nursingpromotion of mental healthnursing intervention

Outcome Measures

Primary Outcomes (5)

  • Case Report Form

    The case report form created by the researcher is a form consisting of questions regarding the contact information, age, marital status, pregnancy information, whether the pregnancy was desired, and whether any treatment was received for the pregnancy of the pregnant women participating in the study. The case report form will be applied to all pregnant women in order to determine the sample group.

    24 - 32. gestational week

  • Edinburgh postpartum depression scale

    It was developed by Cox et al. in 1987, and its validity and reliability have been tested in many countries and different languages to date, and its validity and reliability study in our country was conducted by Engindeniz et al. (1996). The scale consists of 10 items. The items are evaluated in a 4-point Likert format and are scored between 0-3. The lowest score that can be obtained from the scale is 0, and the highest score is 30. Each item in the scale is evaluated as 0, 1, 2, 3, and the scoring is reversed (3, 2, 1, 0) in the evaluation of items 3, 5, 6, 7, 8, 9, and 10.

    pre-test( 24 - 32. gestational week), post-test( (30 to 38 weeks of gestation, 6 weeks after the pretest) , follow-up 1 test, (2 - 4. postnatal week), follow-up 2 test (10 -12. postanal week)

  • Beck Depression Inventory

    eck Depression Inventory is a four-point Likert-type self-assessment scale developed by Beck et al. (1961) to measure the physical, emotional, cognitive and motivational components of depression. The scale is graded between '0-3' and consists of 21 questions. The minimum and maximum values of the scale are 0-63. Although depression is assessed in four degrees on the scale; 5-9 points indicate normal, 10-16 points indicate mild-moderate, 17-29 points indicate moderate-severe and 30-63 points indicate severe depression (Beck et al., 1961). The inventory will be used to support an inclusion-exclusion criterion in determining the target population of the research.

    pre- test( 24 - 32. gestational week),

  • Brief Resilience Scale

    The scale was developed by Smith et al. (2008) to measure the psychological resilience of individuals. KPSS is a 5-point Likert-type, 6-item, self-reporting measurement tool. Items 2, 4 and 6 are reverse coded. KPSS is a 5-point Likert-type scale. It has an answer key of "Not at all appropriate" (1), "Not appropriate" (2), "Somewhat appropriate" (3), "Appropriate" (4), "Completely appropriate" (5). After the reverse coded items in the scale are translated, high scores indicate high psychological resilience.

    pre-test( 24 - 32. gestational week), post-test(30 to 38 weeks of gestation, 6 weeks after the pretest)

  • Postpartum Information Form

    The postpartum interview form is a form that will be applied to both the experimental and control groups after the women give birth. The form evaluates the women's birth dates, birth methods, and whether they received support during the postpartum period.

    Follow-up 1 test, (2 - 4. postnatal week)

Study Arms (2)

SEM

EXPERIMENTAL

these participants are willing to attemp for programme(Stories that Empower Mothers "SEM")

Behavioral: Stories that Empowered Mother

control group

NO INTERVENTION

these participant is control group.this group is expected to complete only the post-test and follow-up tests. Pregnant women will continue routine pregnancy follow-up.

Interventions

this intervention is made by resercher for this research.

Also known as: Stories that Empower Mothers Programme
SEM

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsThe study is conducted with primagravida pregnant women.
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • First pregnancy,
  • Singleton pregnancy,
  • Gestational week between 24-32,
  • Regular doctor follow-up,
  • Scored ≥ 10 on the EDBS,
  • Scored \< 17 on the BDI,
  • Literate,
  • No disability in sensory organs that would prevent communication,
  • Owning a smart phone or computer,
  • Having internet access,
  • Volunteering

You may not qualify if:

  • Being in the first trimester of pregnancy,
  • Being treated/therapized with any psychiatric diagnosis,
  • Having a risky pregnancy,
  • Being at risk of premature birth and developing it,
  • Having any complications related to pregnancy (gestational diabetes, hypertension, bleeding, etc.),
  • The baby is not healthy,
  • Developing complications during and after birth,
  • The baby needs intensive care after birth,
  • Having a baby lost,
  • Having a premature birth (\<37 weeks),
  • The mother has experienced serious daily life difficulties (disaster, loss, etc.),
  • Not attending three or more of the six sessions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ege University

Izmir, 35100, Turkey (Türkiye)

RECRUITING

Related Publications (3)

  • Perkins R, Yorke S, Fancourt D. How group singing facilitates recovery from the symptoms of postnatal depression: a comparative qualitative study. BMC Psychol. 2018 Aug 17;6(1):41. doi: 10.1186/s40359-018-0253-0.

  • Demecs IP, Fenwick J, Gamble J. Women's experiences of attending a creative arts program during their pregnancy. Women Birth. 2011 Sep;24(3):112-21. doi: 10.1016/j.wombi.2010.08.004. Epub 2010 Sep 24.

  • Crane T, Buultjens M, Fenner P. Art-based interventions during pregnancy to support women's wellbeing: An integrative review. Women Birth. 2021 Jul;34(4):325-334. doi: 10.1016/j.wombi.2020.08.009. Epub 2020 Sep 8.

MeSH Terms

Conditions

Depression, Postpartum

Condition Hierarchy (Ancestors)

Puerperal DisordersPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDepressive DisorderMood DisordersMental Disorders

Central Study Contacts

Ege M Topcu, Research Asst.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: The research is conducted in a non-randomised experimental follow-up research design.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
research assistant

Study Record Dates

First Submitted

January 11, 2025

First Posted

January 22, 2025

Study Start

April 1, 2021

Primary Completion

June 10, 2025

Study Completion

November 2, 2025

Last Updated

January 22, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will share

all IPD collected

Shared Documents
STUDY PROTOCOL
Time Frame
december 2025 - december 2028

Locations