Couple-based Interpersonal Psychotherapy on Postnatal Depression and Family Sense of Coherence

Sponsor
The Hong Kong Polytechnic University (Other)
Overall Status
Recruiting
CT.gov ID
NCT03499756
Collaborator
(none)
472
1
2
43.1
11

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Couple-based interpersonal psychotherapy
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
472 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
A Couple-based Interpersonal Psychotherapy on Postnatal Depression and Family Sense of Coherence: a Randomized Controlled Trial
Actual Study Start Date :
May 30, 2019
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Couple-based interpersonal psychotherapy

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
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.

No Intervention: Control

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

Outcome Measures

Primary Outcome Measures

  1. Edinburgh Postnatal Depression Scale [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 Outcome Measures

  1. Edinburgh Postnatal Depression Scale [6 months 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.

  2. Family Sense of Coherence Scale (Short Form) [6 weeks postpartum]

    Family Sense of Coherence Scale Short Form is a 12-item scale assessing the extent to which the family perceives the environment as meaningful, comprehensible and manageable. Each item is scored on a 7-point scale, with total scores ranging from 7 to 84. Higher scores indicates a stronger perception of family life coherence, i.e. better outcome.

  3. Family Sense of Coherence Scale (Short Form) [6 months postpartum]

    Family Sense of Coherence Scale Short Form is a 12-item scale assessing the extent to which the family perceives the environment as meaningful, comprehensible and manageable. Each item is scored on a 7-point scale, with total scores ranging from 7 to 84. Higher scores indicates a stronger perception of family life coherence, i.e. better outcome.

  4. Dyadic Adjustment Scale [6 weeks postpartum]

    Dyadic Adjustment Scale is a 32-item measure with four sub-scales: consensus (13 items), satisfaction (10 items), cohesion (5 items), and affectional expression (4 items). A total score is calculated by summing all four subscales' score, with a range of 0-151. Higher scores indicates better adjustment to one's relationship, i.e. better outcome.

  5. Dyadic Adjustment Scale [6 months postpartum]

    Dyadic Adjustment Scale is a 32-item measure with four sub-scales: consensus (13 items), satisfaction (10 items), cohesion (5 items), and affectional expression (4 items). A total score is calculated by summing all four subscales' score, with a range of 0-151. Higher scores indicates better adjustment to one's relationship, i.e. better outcome.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Queen Elizabeth Hospital Kowloon Hong Kong

Sponsors and Collaborators

  • The Hong Kong Polytechnic University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ngai Fei Wan, Assistant Professor, The Hong Kong Polytechnic University
ClinicalTrials.gov Identifier:
NCT03499756
Other Study ID Numbers:
  • PolyU 156082/17H
First Posted:
Apr 17, 2018
Last Update Posted:
Apr 25, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Ngai Fei Wan, Assistant Professor, The Hong Kong Polytechnic University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 25, 2022