NCT06431672

Brief Summary

This is the first perinatal interpersonal psychotherapy group (P-IPTG) implemented for distressed women from pregnancy to postpartum. The feasibility and effects of P-IPTG are explored.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
258

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

March 15, 2018

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

May 22, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 28, 2024

Completed
Last Updated

May 28, 2024

Status Verified

May 1, 2024

Enrollment Period

2.8 years

First QC Date

May 22, 2024

Last Update Submit

May 27, 2024

Conditions

Keywords

feasibilitygroup psychotherapyinterpersonal psychotherapymaternal depressionperinatal adjustment

Outcome Measures

Primary Outcomes (5)

  • Edinburgh Postnatal Depression Scale

    The Edinburgh Postnatal Depression Scale (EPDS, Cox et al., 1987) was used to assess depressive symptoms. It consists of ten Likert-type items with 0 to 3 points, with higher scores indicating more depressive symptoms over the past week. Following the previous study (Su et al., 2007), we used higher than 12 to define participants with significant depressive tendencies.

    the seventh to ninth month in pregnancy, four month postpartum, eight month postpartum,twelve month postpartum

  • Dyadic Adjustment Scale

    The Dyadic Adjustment Scale (DAS, Spanier, 1976) assessed women's perceived quality of either married or unmarried couple relationship. The scale consists of 32 items, primarily scored in a 6-point scale (27 items). It measures four factors: dyadic consensus, dyadic satisfaction, dyadic cohesion, and affectionate expression. Higher scores indicate better dyadic adjustment in respective aspects.

    the seventh to ninth month in pregnancy, four month postpartum, eight month postpartum,twelve month postpartum

  • Social Network Interaction System Questionnaire (SNISQ, Lay & Liu, 1996)

    The Social Network Interaction System Questionnaire (SNISQ, Lay \& Liu, 1996) was used to evaluate perceptions of social support from partners, original families, and in-laws. The SNISQ consists of nine Likert-type items with 1 to 4 points, with higher scores indicating better- perceived support from specific individuals.

    the seventh to ninth month in pregnancy, four month postpartum, eight month postpartum,twelve month postpartum

  • Satisfaction with Interpersonal Relationships Scale (Chan et al., 2002)

    Chan et al. (2002) used the Satisfaction with Interpersonal Relationships Scale (SWIRS,) to assess women's satisfaction with their relationships with partners and mothers-in-law over the past few weeks. We expanded the scale to include ratings of relationships with fathers, mothers, and fathers-in-law, resulting in five items. The SWIRS is a Likert-type item with 1 to 7 points, with higher scores indicating greater satisfaction with the relationship.

    the seventh to ninth month in pregnancy, four month postpartum, eight month postpartum,twelve month postpartum

  • Mother-Infant Bonding Inventory (Shieh et al., 2015)

    The Mother-Infant Bonding Inventory (MIBI, Shieh et al., 2015) assessed mothers' thoughts, feelings, and commitment toward their infants. The MIBI consists of 25 items scored on 1 to 6 points. Its four factors are proximity, parental adjustment, commitment, and confidence of reciprocity. Higher scores indicate good mother-infant bonding in specific aspects.

    the seventh to ninth month in pregnancy, four month postpartum, eight month postpartum,twelve month postpartum

Study Arms (2)

intervention group

EXPERIMENTAL

The intervention was an eight-session P-IPTG, which consisted of four sessions in pregnancy and four in postpartum. All participants replied to the measures at four waves from baseline to one year postpartum. The outcome variables were within-group and between-group changes in depression, social support, dyadic adjustment, interpersonal relationship satisfaction, and mother-infant bonding.

Other: interpersonal group psychotherapy

control group

NO INTERVENTION

The participants of control group reply questionnaires for four times.

Interventions

Interpersonal psychotherapy (IPT) was developed by Stuart and O'Hara (1995). It addresses four domains of conflict. The intervention is an eight-session P-IPTG, which consisted of four sessions in pregnancy and four in postpartum.

intervention group

Eligibility Criteria

Age20 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailswomen in pregnancy and postpartum
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • women in the third trimester of pregnancy, at least 20 years old, able to read and write in Chinese, and "depressed, anxious, or wishing to improve family relationships."

You may not qualify if:

  • women with schizophrenia, substance use, or suicide risk.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chung Shan Medical University

Taichung, 402, Taiwan

Location

MeSH Terms

Conditions

Depression, PostpartumSocial Adjustment

Condition Hierarchy (Ancestors)

Puerperal DisordersPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDepressive DisorderMood DisordersMental DisordersSocial BehaviorBehavior

Study Officials

  • Peyling Shieh, Ph. D.

    Chung Shan Medical University, Taiwan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

May 22, 2024

First Posted

May 28, 2024

Study Start

March 15, 2018

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

May 28, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

For confidentiality, we plan to share IPD with other researchers by contact.

Locations