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

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ClinicalTrials.gov Identifier: NCT03499756
Recruitment Status : Not yet recruiting
First Posted : April 17, 2018
Last Update Posted : April 17, 2018
Sponsor:
Information provided by (Responsible Party):
Ngai Fei Wan, The Hong Kong Polytechnic University

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
Postnatal Depression Behavioral: Couple-based interpersonal psychotherapy Not Applicable

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 : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Start Date : May 1, 2018
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


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.



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Edinburgh Postnatal Depression Scale [ Time Frame: 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) [ Time Frame: 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) [ 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.

  4. Dyadic Adjustment Scale [ Time Frame: 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 [ Time Frame: 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.



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

Responsible Party: Ngai Fei Wan, Assistant Professor, The Hong Kong Polytechnic University
ClinicalTrials.gov Identifier: NCT03499756     History of Changes
Other Study ID Numbers: PolyU 156082/17H
First Posted: April 17, 2018    Key Record Dates
Last Update Posted: April 17, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
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, The Hong Kong Polytechnic University:
Postnatal depression, interpersonal psychotherapy

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depression, Postpartum
Behavioral Symptoms
Mood Disorders
Mental Disorders
Puerperal Disorders
Pregnancy Complications