Postnatal DepressionNCT03499756
Couple-based Interpersonal Psychotherapy on Postnatal Depression and Family Sense of Coherence
A study testing Couple-based interpersonal psychotherapy in people with Postnatal Depression, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Postnatal Depression
- What is being tested?
- Couple-based interpersonal psychotherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 455 participants
- Where
- 1 siteHong Kong
- Study dates
- 30 May 2019to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- aged 18 or above;
- married, first-time parents, live together;
- able to speak and read Chinese; and Hong Kong residents.
Who cannot join
- a present history of psychiatric illness
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Couple-based Interpersonal Psychotherapy on Postnatal Depression and Family Sense of Coherence: a Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Postnatal Depression
- Being tested
- Couple-based interpersonal psychotherapy
- Keywords
- Postnatal depression, interpersonal psychotherapy
- Medical subject headings
- Depression, Postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Couple-based interpersonal psychotherapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Couple-based interpersonal psychotherapy | Experimental | The intervention consists of three weekly 2-hour antenatal sessions and two 30-minute telephone follow-up sessions delivered within four weeks postpartum. Receives: Behavioral: Couple-based interpersonal psychotherapy |
| Control | No intervention | The control group will receive the standard prenatal and postnatal care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 weeks postpartum
Secondary outcomes (5)
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.
Measured: 6 months postpartum
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.
Measured: 6 weeks postpartum
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.
Measured: 6 months postpartum
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.
Measured: 6 weeks postpartum
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.
Measured: 6 months postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2018
- Study start30 May 2019
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postnatal DepressionStudies of the same condition, open and under way.
- More trials run by The Hong Kong Polytechnic UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 455 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ngai Fei Wan, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03499756
- Sponsor's protocol ID
- PolyU 156082/17H
- Status last verified
- May 2023
- First submitted
- 3 Apr 2018
- Last updated
- 10 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Couple-based Interpersonal Psychotherapy on Postnatal Depression and Family Sense of Coherence: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03499756
- Acronym / sponsor ID
- PolyU 156082/17H
- Conditions
- Postnatal Depression
- Keywords
- Postnatal depression, interpersonal psychotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 455 participants (actual)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 30 May 2019 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 17 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Couple-based interpersonal psychotherapy | Experimental | Behavioral: Couple-based interpersonal psychotherapyThe intervention consists of three weekly 2-hour antenatal sessions and two 30-minute telephone follow-up sessions delivered within four weeks postpartum. |
| Control | No intervention | –The control group will receive the standard prenatal and postnatal care. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- aged 18 or above;
- married, first-time parents, live together;
- able to speak and read Chinese; and Hong Kong residents.
Key exclusion criteria (1 listed)
- a present history of psychiatric illness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Couple-based interpersonal psychotherapyThe 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. | Behavioural | Couple-based interpersonal psychotherapy |
Primary outcome
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.
5 secondary outcomes
Edinburgh Postnatal Depression Scale
Time frame: 6 months postpartum
Family Sense of Coherence Scale (Short Form)
Time frame: 6 weeks postpartum
Family Sense of Coherence Scale (Short Form)
Time frame: 6 months postpartum
Dyadic Adjustment Scale
Time frame: 6 weeks postpartum
Dyadic Adjustment Scale
Time frame: 6 months postpartum
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Couple-based interpersonal psychotherapy in people with Postnatal Depression, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Edinburgh Postnatal Depression Scale (time frame: 6 weeks postpartum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2023.