Postpartum DepressionNCT07636005
Psychological Empowerment Program in Preventing Postpartum Depression Among Pregnant Women
A study testing Psychological Empowerment Program in people with Postpartum Depression, run by Miranie Safaringga at 1 site in Indonesia.
Trial summary
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. 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
- What is being tested?
- Psychological Empowerment Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteIndonesia
- Study dates
- 10 Mar 2026to 30 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Primary Health Centre Lubuk Begalung
Padang, West Sumatra, 25163
About this study
Official title: 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:
- Does the Psychological Empowerment program prevent postpartum depression at 6 weeks after delivery?
- Does the Psychological Empowerment program improve self-control of the postpartum women at 6 weeks after delivery?
- Does the Psychological Empowerment program improve the self-efficacy of postpartum women at 6 weeks after delivery?
- Does the Psychological Empowerment program provide a tendency to have adaptive coping strategies in women 6 weeks after delivery?
Read more
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
Read the detailed description
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.
- Conditions
- Postpartum Depression
- Being tested
- Psychological Empowerment Program
- Keywords
- Postpartum depression, psychological empowerment
- Medical subject headings
- Depression, Postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychological Empowerment ProgramBehavioural
Also called PEP
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: - 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
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.
Measured: - 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
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.
Measured: - 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
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.
Measured: - 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2026
- Study start10 Mar 2026
- Primary completion25 Aug 2026 (estimated)
- Study completion30 Aug 2026 (estimated)
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
- Masking
- None (open label)
- Enrolment
- 92 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Miranie Safaringga
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Miranie Safaringga, National Taipei University of Nursing and Health Sciences
- Investigators
- Yu Ying Lu, Professor, Principal investigator, National Taipei University of Nursing and Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07636005
- Sponsor's protocol ID
- NTUNHS_01
- Status last verified
- Jun 2026
- First submitted
- 28 May 2026
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Psychological Empowerment Program in Preventing Postpartum Depression Among Pregnant Women in Indonesia: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07636005
- Acronym / sponsor ID
- NTUNHS_01
- Conditions
- Postpartum Depression
- Keywords
- Postpartum depression, psychological empowerment
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 92 participants (estimated)
- Lead sponsor
- Miranie SafaringgaUniversity, hospital or other
- Study start
- 10 Mar 2026 (actual)
- Primary completion
- 25 Aug 2026 (estimated)
- Study completion
- 30 Aug 2026 (estimated)
- First posted
- 9 Jun 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.
The goal of this clinical trial is to prevent postpartum depression in pregnant women. The main questions it aims to answer are:
- Does the Psychological Empowerment program prevent postpartum depression at 6 weeks after delivery?
- Does the Psychological Empowerment program improve self-control of the postpartum women at 6 weeks after delivery?
- Does the Psychological Empowerment program improve the self-efficacy of postpartum women at 6 weeks after delivery?
- 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
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Psychological Empowerment ProgramParticipants 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
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 |
|---|---|---|
| Psychological Empowerment ProgramAlso: PEPThe 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. | Behavioural | Intervention Group |
Primary outcome
Postpartum Depression
Time frame: - 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.
3 secondary outcomes
Perceived Control
Time frame: - 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
Time frame: - 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
Time frame: - 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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2026.
- Individual participant dataSharing planned: Yes. 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.
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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.
Yu Ying Lu, Professor principal investigator
National Taipei University of Nursing and Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychological Empowerment Program in people with Postpartum Depression, run by Miranie Safaringga at 1 site in Indonesia.
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 5 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: under way, not looking for participants, as of the sponsor's last update on 9 Jun 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 Indonesia. 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?
This study is still under way. Results are not available in the source record yet.
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 Depression (time frame: - 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)). 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 9 Jun 2026.