## Protocol Section
### Identification Module
**NCT ID:** NCT06431672

**Brief Title:** Perinatal Interpersonal Psychotherapy Group for Distressed Women

**Official Title:** The Feasibility and Effects of Perinatal Interpersonal Psychotherapy Group for Distressed Women

#### Organization Study ID Info
**ID:** MOST 106-2410-H-040-004 -SSS
#### Organization
**Class:** OTHER
**Full Name:** Chung Shan Medical University
#### Secondary ID Infos
**Domain:** Ministry of Science and Technology, Taiwan
**ID:** MOST 107-2410-H-040-005 -SSS
**Type:** OTHER_GRANT
### Status Module
#### Completion Date
**Date:** 2020-12-31

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-28

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-27

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2020-12-31

**Type:** ACTUAL

#### Start Date
**Date:** 2018-03-15

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-22
**Study First Submit QC Date:** 2024-05-27
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Chung Shan Medical University

#### Responsible Party

**Investigator Affiliation:** Chung Shan Medical University

**Investigator Full Name:** Peyling Shieh

**Investigator Title:** Associate professor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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.

**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.

### Conditions Module

**Conditions:**

- Depression, Postpartum

- Social Adjustment

**Keywords:**

- feasibility

- group psychotherapy

- interpersonal psychotherapy

- maternal depression

- perinatal adjustment

### Design Module

#### Design Info

**Allocation:** NON_RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** PREVENTION

#### Enrollment Info

**Count:** 258

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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.

**Intervention Names:**

- Other: interpersonal group psychotherapy

**Label:** intervention group

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** The participants of control group reply questionnaires for four times.

**Label:** control group

**Type:** NO_INTERVENTION

### Interventions

#### Intervention 1

**Arm Group Labels:**

- intervention group

**Description:** 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.

**Name:** interpersonal group psychotherapy

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**Measure:** Edinburgh Postnatal Depression Scale

**Time Frame:** the seventh to ninth month in pregnancy, four month postpartum, eight month postpartum,twelve month postpartum

**Description:** 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.

**Measure:** Dyadic Adjustment Scale

**Time Frame:** the seventh to ninth month in pregnancy, four month postpartum, eight month postpartum,twelve month postpartum

**Description:** 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.

**Measure:** 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

**Description:** 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.

**Measure:** 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

**Description:** 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.

**Measure:** 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

### Eligibility Module

**Eligibility Criteria:** 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.

**Gender Based:** True

**Gender Description:** women in pregnancy and postpartum

**Healthy Volunteers:** True

**Minimum Age:** 20 Years

**Sex:** FEMALE

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Taichung

**Country:** Taiwan

**Facility:** Chung Shan Medical University

**Zip:** 402

#### Overall Officials

**Official 1:**

**Affiliation:** Chung Shan Medical University, Taiwan

**Name:** Peyling Shieh, Ph. D.

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

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

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000001526

- Term: Behavioral Symptoms

- ID: D000003866

- Term: Depressive Disorder

- ID: D000019964

- Term: Mood Disorders

- ID: D000001523

- Term: Mental Disorders

- ID: D000011644

- Term: Puerperal Disorders

- ID: D000011248

- Term: Pregnancy Complications

- ID: D000005261

- Term: Female Urogenital Diseases and Pregnancy Complications

- ID: D000091642

- Term: Urogenital Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: All

- Name: All Conditions

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

### Condition Browse Module - Browse Leaves

- ID: M7058

- Name: Depression

- Relevance: HIGH

- As Found: Depression

- ID: M7061

- Name: Depressive Disorder

- Relevance: LOW

- As Found: Unknown

- ID: M21076

- Name: Depression, Postpartum

- Relevance: HIGH

- As Found: Depression, Postpartum

- ID: M4818

- Name: Behavioral Symptoms

- Relevance: LOW

- As Found: Unknown

- ID: M21835

- Name: Mood Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M4815

- Name: Mental Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M14473

- Name: Psychotic Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M14499

- Name: Puerperal Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M14127

- Name: Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M27093

- Name: Female Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8399

- Name: Female Urogenital Diseases and Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000019052

- Term: Depression, Postpartum

- ID: D000003863

- Term: Depression

### Misc Info Module

- Version Holder: 2024-05-31
