- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03499756
Couple-based Interpersonal Psychotherapy on Postnatal Depression and Family Sense of Coherence
A Couple-based Interpersonal Psychotherapy on Postnatal Depression and Family Sense of Coherence: a Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Fei Wan Ngai, PhD
- Phone Number: 6775 2766
- Email: vivian.ngai@polyu.edu.hk
Study Locations
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Kowloon, Hong Kong
- Queen Elizabeth Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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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.
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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.
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No Intervention: Control
The control group will receive the standard prenatal and postnatal care.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Edinburgh Postnatal Depression Scale
Time Frame: 6 weeks postpartum
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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.
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6 weeks postpartum
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Edinburgh Postnatal Depression Scale
Time Frame: 6 months postpartum
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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.
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6 months postpartum
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Family Sense of Coherence Scale (Short Form)
Time Frame: 6 weeks postpartum
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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.
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6 weeks postpartum
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Family Sense of Coherence Scale (Short Form)
Time Frame: 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.
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6 months postpartum
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Dyadic Adjustment Scale
Time Frame: 6 weeks postpartum
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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.
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6 weeks postpartum
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Dyadic Adjustment Scale
Time Frame: 6 months postpartum
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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.
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6 months postpartum
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PolyU 156082/17H
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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