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

Postnatal Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03499756
• Other study ID #: PolyU 156082/17H
• Status: Completed
• Phase: N/A
• Start date: May 30, 2019
• Est. completion date: December 31, 2022

Study information

• Verified date: May 2023
• Source: The Hong Kong Polytechnic University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 455
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depression, Postpartum
• Depressive Disorder
• Postnatal Depression

Intervention

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.

Locations

Country	Name	City	State
Hong Kong	Queen Elizabeth Hospital	Kowloon

Sponsors (1)

Lead Sponsor	Collaborator
The Hong Kong Polytechnic University

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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 months postpartum
Secondary	Family Sense of Coherence Scale (Short Form)	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.	6 weeks postpartum
Secondary	Family Sense of Coherence Scale (Short Form)	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.	6 months postpartum
Secondary	Dyadic Adjustment Scale	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.	6 weeks postpartum
Secondary	Dyadic Adjustment Scale	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.	6 months postpartum