Psychological Empowerment Program in Preventing Postpartum Depression Among Pregnant Women

NCT07636005 | Active Not Recruiting

• 1 other identifier: NTUNHS_01
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

Brief Summary

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

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

Conditions

Postpartum Depression

Keywords

Postpartum depression; psychological empowerment

Outcome Measures

Primary Outcomes (1)

• Postpartum Depression

  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)

Secondary Outcomes (3)

• Perceived 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

  - 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

  - 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)

Study Arms (2)

Intervention Group

EXPERIMENTAL

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.

Behavioral: Psychological Empowerment Program

Control Group

NO INTERVENTION

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.

Interventions

Psychological Empowerment Program BEHAVIORAL

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.

Also known as: PEP

Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Participant must be a pregant women who expected first child with a gestational age range of 30-33 weeks
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Miranie Safaringga: lead

Study Sites (1)

Primary Health Centre Lubuk Begalung

Padang, West Sumatra, 25163, Indonesia

Location

MeSH Terms

Conditions

Depression, Postpartum

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Yu Ying Lu, Professor

  National Taipei University of Nursing and Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Doctoral Researcher

Study Record Dates

• First Submitted: May 28, 2026
• First Posted: June 9, 2026
• Study Start: March 10, 2026
• Primary Completion (Estimated): August 25, 2026
• Study Completion (Estimated): August 30, 2026
• Last Updated: June 9, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 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.
• Access Criteria: 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.

Locations

ID (1)