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Psychological Empowerment Program in Preventing Postpartum Depression Among Pregnant Women

4. juni 2026 opdateret af: Miranie Safaringga

The Effectiveness of Psychological Empowerment Program in Preventing Postpartum Depression Among Pregnant Women in Indonesia: A Randomized Controlled Trial

The goal of this clinical trial is to prevent postpartum depression in pregnant women. The main questions it aims to answer are:

  1. Does the Psychological Empowerment program prevent postpartum depression at 6 weeks after delivery?
  2. Does the Psychological Empowerment program improve self-control of the postpartum women at 6 weeks after delivery?
  3. Does the Psychological Empowerment program improve the self-efficacy of postpartum women at 6 weeks after delivery?
  4. Does the Psychological Empowerment program provide a tendency to have adaptive coping strategies in women 6 weeks after delivery?

Researchers will compare the intervention group to a control group with no intervention (routine care) to see if the psychological empowerment program can prevent postpartum depression at 6 weeks after delivery.

Participants in the intervention group will :

  • receive 5 sessions in 3 weeks ( 2 sessions per week)
  • get follow-up at 2 weeks and 6 weeks after delivery

Studieoversigt

Status

Aktiv, ikke rekrutterende

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Postpartum depression (PPD) is a common mental health problem that affects women during pregnancy and after childbirth. Women with postpartum depression may experience persistent sadness, anxiety, stress, low self-confidence, sleep disturbances, difficulty bonding with their baby, and emotional distress that can interfere with daily functioning and family relationships. In Indonesia, the prevalence of postpartum depression remains high, while preventive mental health services for pregnant women are still limited. Maternal care services primarily focus on physical health, with minimal attention given to psychological preparation and emotional well-being during pregnancy.

This study aims to evaluate the effectiveness of a Psychological Empowerment Program in preventing postpartum depression among pregnant women in Indonesia. The program is based on Zimmerman's Psychological Empowerment Theory and is designed to strengthen women's perceived control, self-efficacy, coping behaviour during pregnancy and the transition to motherhood.

This research will use a randomized controlled trial (RCT) design. Eligible pregnant women in their third trimester, together with their partners, will be randomly assigned to either an intervention group or a control group. Participants in the intervention group will receive the Psychological Empowerment Program in addition to routine antenatal care, while participants in the control group will receive standard antenatal and postnatal care only.

The intervention consists of structured weekly sessions delivered through interactive discussions, guided activities, emotional coping exercises, communication training, problem-solving activities, and empowerment-focused education. Topics include understanding emotional changes during pregnancy, increasing self-confidence in motherhood, improving coping strategies,, and building practical parenting skills. Sessions will be facilitated by trained healthcare professionals, including midwives, psychologists, and mental health nurses. (facilitator training will be conducted before the intervention)

The study will measure depressive symptoms, self-efficacy, perceived control, and coping strategies before the intervention, after completion of the program, and during the postpartum follow-up period. Standardized questionnaires, including the Edinburgh Postnatal Depression Scale (EPDS), General Self-Efficacy Scale (GSES), Pearlin Mastery Scale, and Brief COPE Inventory, will be used to evaluate outcomes.

The findings from this study are expected to provide evidence for culturally appropriate and empowerment-based strategies to prevent postpartum depression in Indonesia. The program may contribute to improving maternal mental health services, strengthening family support systems, and promoting healthier outcomes for mothers, infants, and families.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

92

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Indonesien
    • West Sumatra
      • Padang, West Sumatra, Indonesien, 25163
        • Primary Health Centre Lubuk Begalung

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ja

Beskrivelse

Inclusion Criteria :

  • Pregnant women between 30-33 weeks of gestation
  • Primiparous
  • Age 18 years and above
  • Able to read and communicate in the local language
  • Living with a partner

Exclusion Criteria:

  • History of diagnosed psychiatric illness (e.g., bipolar disorder, schizophrenia)
  • High-risk pregnancy conditions that require specialized medical care
  • Unwilling or unable to commit to the intervention schedule

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Intervention Group
Participants assigned to the intervention group will receive the Psychological Empowerment Program in addition to routine care. A total of 46 pregnant women will be divided into four groups based on their time convenience, with each group consisting of 10-12 women. It would be beneficial to increase intervention fidelity and make it easier for the researcher to follow up at the time, as well as provide opportunities for more interactions within the peer group. Each group will receive the intervention at a different time. The program consists of structured 5 sessions in 3 weekly sessions (2 sessions in one week). Sessions include psychoeducation, guided discussions, emotional coping exercises, communication and conflict resolution training, problem-solving activities, and practical parenting preparation The intervention is delivered by trained midwives, psychologists, and mental health nurses, through interactive workshops and supportive group activities.
Adfærdsmæssigt: Psychological Empowerment Program

The Psychological Empowerment Program is a theory-based behavioura intervention designed for pregnant women to prevent postpartum depression. The intervention is based on Zimmerman's Psychological Empowerment Theory and focuses on strengthening perceived control, self-efficacy, and coping behaviour during pregnancy and the transition to motherhood.

The program consists of 5 structured sessions conducted in 3 weeks a, each lasting approximately 90 minutes. Sessions are delivered in small groups (12 participants each group) through interactive workshops, guided discussions, role-play activities, coping skills training, communication exercises, problem-solving simulations, and reflective journaling. The intervention includes psychoeducation on postpartum depression, stress management techniques, emotional regulation strategies, assertive communication training, and practical preparation for parenting challenges.

Andre navne:
  • PEP
Ingen indgriben: Control Group
Participants assigned to the control group will receive routine antenatal and postnatal care provided by the healthcare facility, including standard health education and pregnancy monitoring, without the structured psychological empowerment intervention.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Postpartum Depression
Tidsramme: - From enrollment to the end of the intervention will take 3 weeks (during pregnancy, participants' gestation age in the range 35-38 weeks) - Follow-up 1: at 2 weeks after delivery - Follow-up 2: at 6 weeks after delivery (each participant may vary)
Postpartum Depression Symptoms (EPDS) The Edinburgh Postnatal Depression Scale (EPDS) is a 10-item self-report questionnaire used to assess depressive symptoms during the perinatal period. Each item is scored on a 4-point scale (0-3), with total scores ranging from 0 to 30. Higher scores indicate more severe depressive symptoms. A score of 13 or higher is considered indicative of probable postpartum depression and suggests the need for further psychological assessment. Lower scores represent better mental health outcomes and fewer depressive symptoms.
- From enrollment to the end of the intervention will take 3 weeks (during pregnancy, participants' gestation age in the range 35-38 weeks) - Follow-up 1: at 2 weeks after delivery - Follow-up 2: at 6 weeks after delivery (each participant may vary)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Perceived Control
Tidsramme: - From enrollment to the end of the intervention will take 3 weeks (during pregnancy, participants' gestation age in the range 35-38 weeks) - Follow-up 1: at 2 weeks after delivery - Follow-up 2: at 6 weeks after delivery (each participant may vary)
Perceived Control measure using Pearlin Mastery Scale The Pearlin Mastery Scale is a 7-item questionnaire that assesses an individual's perceived sense of control over life circumstances. Items are rated on a 4-point Likert scale ranging from 1 ("Strongly agree") to 4 ("Strongly disagree"). Total scores range from 7 to 28. Higher scores indicate a stronger sense of personal mastery and perceived control over life events, whereas lower scores indicate feelings of helplessness and reduced control.
- From enrollment to the end of the intervention will take 3 weeks (during pregnancy, participants' gestation age in the range 35-38 weeks) - Follow-up 1: at 2 weeks after delivery - Follow-up 2: at 6 weeks after delivery (each participant may vary)
Self Efficacy
Tidsramme: - From enrollment to the end of the intervention will take 3 weeks (during pregnancy, participants' gestation age in the range 35-38 weeks) - Follow-up 1: at 2 weeks after delivery - Follow-up 2: at 6 weeks after delivery (each participant may vary)
Self-Efficacy measure used The General Self-Efficacy Scale (GSES). GSES is a 10-item self-report instrument measuring an individual's confidence in managing stressful situations and overcoming challenges. Each item is rated on a 4-point Likert scale ranging from 1 ("Not at all true") to 4 ("Exactly true"). Total scores range from 10 to 40. Higher scores indicate greater self-efficacy and stronger confidence in one's ability to cope with difficulties, while lower scores indicate lower perceived self-efficacy.
- From enrollment to the end of the intervention will take 3 weeks (during pregnancy, participants' gestation age in the range 35-38 weeks) - Follow-up 1: at 2 weeks after delivery - Follow-up 2: at 6 weeks after delivery (each participant may vary)
Coping Behavior
Tidsramme: - From enrollment to the end of the intervention will take 3 weeks (during pregnancy, participants' gestation age in the range 35-38 weeks) - Follow-up 1: at 2 weeks after delivery - Follow-up 2: at 6 weeks after delivery (each participant may vary)
Coping Behavior will asess usind The Brief COPE Inventory. The Brief COPE Inventory is a 28-item self-report instrument used to assess adaptive and maladaptive coping strategies. Each item is scored on a 4-point Likert scale ranging from 1 ("I haven't been doing this at all") to 4 ("I've been doing this a lot"). Subscale scores are calculated for different coping domains. Higher scores on adaptive coping domains (e.g., active coping, emotional support, positive reframing) indicate better coping abilities, while higher scores on maladaptive coping domains (e.g., denial, behavioral disengagement, self-blame) indicate less effective coping strategies.
- From enrollment to the end of the intervention will take 3 weeks (during pregnancy, participants' gestation age in the range 35-38 weeks) - Follow-up 1: at 2 weeks after delivery - Follow-up 2: at 6 weeks after delivery (each participant may vary)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Miranie Safaringga

Efterforskere

  • Ledende efterforsker: Yu Ying Lu, Professor, National Taipei University of Nursing and Health Sciences

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

10. marts 2026

Primær færdiggørelse (Anslået)

25. august 2026

Studieafslutning (Anslået)

30. august 2026

Datoer for studieregistrering

Først indsendt

28. maj 2026

Først indsendt, der opfyldte QC-kriterier

4. juni 2026

Først opslået (Faktiske)

9. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

9. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

4. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • NTUNHS_01

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

All IPD that underlie results in a publication will be shared. The shared datasets may include participant demographic characteristics, baseline measures, intervention allocation, and outcome data collected at all study time points, including scores on the Edinburgh Postnatal Depression Scale (EPDS), the General Self-Efficacy Scale (GSES), the Pearlin Mastery Scale, and the Brief COPE Inventory. Data will be provided in a de-identified format to protect participant confidentiality.

IPD-delingstidsramme

De-identified individual participant data (IPD) and supporting documentation will be available beginning 6 months after publication of the primary study results and will remain available for 5 years following publication.

IPD-delingsadgangskriterier

Data will be available to qualified researchers who provide a methodologically sound research proposal. Requests will be reviewed by the principal investigator. Data will be shared after approval of a data use agreement designed to protect participant confidentiality.

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

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