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Clinical Trials/NCT03499756
NCT03499756
Completed
Not Applicable

A Couple-based Interpersonal Psychotherapy on Postnatal Depression and Family Sense of Coherence: a Randomized Controlled Trial

The Hong Kong Polytechnic University1 site in 1 country455 target enrollmentMay 30, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Postnatal Depression
Sponsor
The Hong Kong Polytechnic University
Enrollment
455
Locations
1
Primary Endpoint
Edinburgh Postnatal Depression Scale
Status
Completed
Last Updated
2 years ago

Overview

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.

Detailed Description

Background: 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. Enhancement of family sense of coherence may be helpful for women who are at risk for postnatal depression. However, few studies in the context of Chinese parenthood have evaluated the effect of interpersonal psychotherapy on postnatal depression and the underlying mechanisms. Aim: To examine the effect of a couple-based interpersonal psychotherapy for first-time Chinese mothers and fathers on depressive symptoms (primary outcome), family sense of coherence (secondary outcome), and marital relationships (secondary outcome) immediately after intervention and at 6 weeks and 6 months postpartum. Method: A randomized controlled trial will be used to evaluate the effect of a couple-based interpersonal psychotherapy on depressive symptoms (primary outcome), family sense of coherence (secondary outcome), and marital relationships (secondary outcome) immediately after intervention and at 6 weeks and 6 months postpartum. A convenience sample of 125 couples will be recruited at the antenatal clinics and randomly assigned to either experimental or control group. The experimental group will receive the intervention in addition to the standard perinatal care, while the control group will only receive the standard perinatal care. Intervention: The intervention consists of three weekly 2-hour antenatal sessions using an interpersonal psychotherapy approach that focused on enhancement of family sense of coherence and two telephone follow-ups within the first four weeks after delivery. Outcome measures: The primary outcome measure of postnatal depression will be assessed by the Edinburgh Postnatal Depression Scale. Secondary outcome measures of family sense of coherence and the marital relationship, will be assessed by the Family Sense of Coherence Scale and Dyadic Adjustment, respectively, at baseline, immediately post-intervention, 6 weeks and 6 months postpartum. Data analysis: Linear mixed models will be used to test for significant differences between the groups on outcome variables.

Registry
clinicaltrials.gov
Start Date
May 30, 2019
End Date
December 31, 2022
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ngai Fei Wan

Assistant Professor

The Hong Kong Polytechnic University

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • a present history of psychiatric illness

Outcomes

Primary Outcomes

Edinburgh Postnatal Depression Scale

Time Frame: 6 weeks postpartum

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.

Secondary Outcomes

  • Dyadic Adjustment Scale(6 months postpartum)
  • Family Sense of Coherence Scale (Short Form)(6 months postpartum)
  • Edinburgh Postnatal Depression Scale(6 months postpartum)

Study Sites (1)

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