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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06431672
Other study ID # MOST 106-2410-H-040-004 -SSS
Secondary ID MOST 107-2410-H-
Status Completed
Phase N/A
First received
Last updated
Start date March 15, 2018
Est. completion date December 31, 2020

Study information

Verified date May 2024
Source Chung Shan Medical University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 258
Est. completion date December 31, 2020
Est. primary completion date December 31, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 20 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
interpersonal group psychotherapy
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.

Locations

Country Name City State
Taiwan Chung Shan Medical University Taichung

Sponsors (1)

Lead Sponsor Collaborator
Chung Shan Medical University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
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