Clinical trial NCT03499756: Couple-based Interpersonal Psychotherapy on Postnatal Depression and Family Sense of Coherence
Official title: A Couple-based Interpersonal Psychotherapy on Postnatal Depression and Family Sense of Coherence: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postnatal Depression
Keywords: Postnatal depression, interpersonal psychotherapy
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2018-04-17
Enrollment: 455
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Edinburgh Postnatal Depression Scale
timeFrame: 6 weeks postpartum
Secondary outcomes:
measure: Edinburgh Postnatal Depression Scale
timeFrame: 6 months postpartum
measure: Family Sense of Coherence Scale (Short Form)
timeFrame: 6 weeks postpartum
measure: Family Sense of Coherence Scale (Short Form)
timeFrame: 6 months postpartum
measure: Dyadic Adjustment Scale
timeFrame: 6 weeks postpartum
measure: Dyadic Adjustment Scale
timeFrame: 6 months postpartum
Other outcomes:
Locations:
city: Kowloon
country: Hong Kong
facility: Queen Elizabeth Hospital
Study officials:
References: