NCT03499756

Brief Summary

Postnatal depression is a common public health problem which has long-term sequelae on the family and the infant's psychosocial development. Interpersonal psychotherapy has demonstrated its value as one of the most effective interventions for postnatal depression. The aim of this study is to examine the effect of a couple-based interpersonal psychotherapy for first-time Chinese mothers and fathers on depressive symptoms, family sense of coherence, and marital relationships immediately after intervention and at 6 weeks and 6 months postpartum.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
455

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2019

Longer than P75 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

First Submitted

Initial submission to the registry

April 3, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 17, 2018

Completed
1.1 years until next milestone

Study Start

First participant enrolled

May 30, 2019

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

May 10, 2023

Status Verified

May 1, 2023

Enrollment Period

3.6 years

First QC Date

April 3, 2018

Last Update Submit

May 9, 2023

Conditions

Keywords

Postnatal depression, interpersonal psychotherapy

Outcome Measures

Primary Outcomes (1)

  • Edinburgh Postnatal Depression Scale

    Edinburgh Postnatal Depression Scale is a 10-item self-report scale assessing the presence of depressive symptoms in the postnatal period. Each item is scored on a 4-point scale with total scores ranging from 0 to 30. Higher score indicates greater depressive symptoms, i.e. worse outcome.

    6 weeks postpartum

Secondary Outcomes (5)

  • Edinburgh Postnatal Depression Scale

    6 months postpartum

  • Family Sense of Coherence Scale (Short Form)

    6 weeks postpartum

  • Family Sense of Coherence Scale (Short Form)

    6 months postpartum

  • Dyadic Adjustment Scale

    6 weeks postpartum

  • Dyadic Adjustment Scale

    6 months postpartum

Study Arms (2)

Couple-based interpersonal psychotherapy

EXPERIMENTAL

The intervention consists of three weekly 2-hour antenatal sessions and two 30-minute telephone follow-up sessions delivered within four weeks postpartum.

Behavioral: Couple-based interpersonal psychotherapy

Control

NO INTERVENTION

The control group will receive the standard prenatal and postnatal care.

Interventions

The contents include: (1) an overview of changes associated with the role transition of parenthood and an introduction to the coping skills relating to role transition and parenting; (2) discussing common postpartum and interpersonal difficulties, such as conflicts with partners or extended family, and teaching effective communication skills to resolve interpersonal conflicts and maintain a good interpersonal relationship; and (3) building family strengths and resources by enhancing family sense of coherence, such as reassessing the challenges of the new role, applying problem solving techniques to deal with role transition and interpersonal problems, and developing new social support.

Couple-based interpersonal psychotherapy

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • aged 18 or above;
  • married, first-time parents, live together;
  • able to speak and read Chinese; and Hong Kong residents.

You may not qualify if:

  • a present history of psychiatric illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Queen Elizabeth Hospital

Kowloon, Hong Kong

Location

MeSH Terms

Conditions

Depression, Postpartum

Condition Hierarchy (Ancestors)

Puerperal DisordersPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDepressive DisorderMood DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 3, 2018

First Posted

April 17, 2018

Study Start

May 30, 2019

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

May 10, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations