- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06431672
Perinatal Interpersonal Psychotherapy Group for Distressed Women
May 27, 2024 updated by: Peyling Shieh, Chung Shan Medical University
The Feasibility and Effects of Perinatal Interpersonal Psychotherapy Group for Distressed Women
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
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.
The third-trimester women were recruited as intervention and control group participants by a quasi-experimental design.
Study Type
Interventional
Enrollment (Actual)
258
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Taichung, Taiwan, 402
- Chung Shan Medical University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 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."
Exclusion Criteria:
- women with schizophrenia, substance use, or suicide risk.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: intervention group
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.
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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.
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No Intervention: control group
The participants of control group reply questionnaires for four times.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Edinburgh Postnatal Depression Scale
Time Frame: the seventh to ninth month in pregnancy, four month postpartum, eight month postpartum,twelve month postpartum
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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.
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the seventh to ninth month in pregnancy, four month postpartum, eight month postpartum,twelve month postpartum
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Dyadic Adjustment Scale
Time Frame: the seventh to ninth month in pregnancy, four month postpartum, eight month postpartum,twelve month postpartum
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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.
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the seventh to ninth month in pregnancy, four month postpartum, eight month postpartum,twelve month postpartum
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Social Network Interaction System Questionnaire (SNISQ, Lay & Liu, 1996)
Time Frame: the seventh to ninth month in pregnancy, four month postpartum, eight month postpartum,twelve month postpartum
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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.
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the seventh to ninth month in pregnancy, four month postpartum, eight month postpartum,twelve month postpartum
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Satisfaction with Interpersonal Relationships Scale (Chan et al., 2002)
Time Frame: the seventh to ninth month in pregnancy, four month postpartum, eight month postpartum,twelve month postpartum
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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.
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the seventh to ninth month in pregnancy, four month postpartum, eight month postpartum,twelve month postpartum
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Mother-Infant Bonding Inventory (Shieh et al., 2015)
Time Frame: the seventh to ninth month in pregnancy, four month postpartum, eight month postpartum,twelve month postpartum
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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.
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the seventh to ninth month in pregnancy, four month postpartum, eight month postpartum,twelve month postpartum
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Peyling Shieh, Ph. D., Chung Shan Medical University, Taiwan
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 15, 2018
Primary Completion (Actual)
December 31, 2020
Study Completion (Actual)
December 31, 2020
Study Registration Dates
First Submitted
May 22, 2024
First Submitted That Met QC Criteria
May 27, 2024
First Posted (Actual)
May 28, 2024
Study Record Updates
Last Update Posted (Actual)
May 28, 2024
Last Update Submitted That Met QC Criteria
May 27, 2024
Last Verified
May 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MOST 106-2410-H-040-004 -SSS
- MOST 107-2410-H-040-005 -SSS (Other Grant/Funding Number: Ministry of Science and Technology, Taiwan)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
For confidentiality, we plan to share IPD with other researchers by contact.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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