Postnatal DepressionNCT01507649
Effect of a Telephone-based Intervention on Postnatal Depression
A study testing telephone-based cognitive-behavioral intervention in people with Postnatal Depression, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
Purpose: To evaluate the effectiveness of a telephone-based intervention using cognitive-behavioral approach in preventing postnatal depression and improving quality of life in first-time Chinese mothers. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Postnatal Depression
- What is being tested?
- telephone-based cognitive-behavioral intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 397 participants
- Where
- 1 siteHong Kong
- Study dates
- Jul 2012to Dec 2014
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- aged 18 or above
- first-time mother
- have given birth to a single full-term healthy baby
- able to speak and read the Chinese language
- Hong Kong residents
- score above 9 on EPDS.
Who cannot join
- single
- having complications after delivery
- having regular follow up with psychiatrists
- currently taking antidepressant or antipsychotic drugs.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of a Telephone-based Cognitive-behavioral Intervention on Postnatal Depression: a Randomized Controlled Trial
Purpose: To evaluate the effectiveness of a telephone-based intervention using cognitive-behavioral approach in preventing postnatal depression and improving quality of life in first-time Chinese mothers.
Hypothesis: Women who receive the telephone-based cognitive-behavioral intervention will have a lower level of depressive symptoms (primary outcome) and a higher level of quality of life at 6 weeks and 6 months postpartum than those who receive the usual postpartum care.
Read more
Design and subjects: Randomized controlled trial is used. A sample of postpartum women with high risk of postnatal depression (EPDS > 9, n = 498) will be randomly assigned to either the experimental (n = 249) or the control groups (n = 249). The experimental group receives the intervention and the control group receives usual postpartum care.
Study instruments: EPDS and Medical Outcomes Study Short Form Health Survey (SF-12).
Interventions: The intervention is based on the cognitive-behavioral approach. It consists of five, 30-minutes sessions delivered weekly from postpartum week one to week five via telephone.
Main outcome measures and analysis: Outcomes on postnatal depression and quality of life will be measured by EPDS and SF-12, respectively, at 6 weeks and 6 months postpartum. A repeated-measures multivariate analysis of variance will be used to compare differences between two groups.
Read the detailed description
The aim of this study is to design, implement and evaluate a telephone-based intervention using cognitive-behavioral approach for first-time mothers during the immediate postpartum period. The objective is to evaluate the effect of a telephone-based intervention using cognitive-behavioral approach on postnatal depression and quality of life at 6 weeks and 6 months postpartum.
A longitudinal, randomized, pre and post-test control group design will be used. This design involves providing a 5-week telephone-based intervention using cognitive-behavioral approach at the immediate postpartum period (first five weeks postpartum) to women with high risk of postnatal depression. The experimental group receives the intervention on top of the usual postpartum care, while the control group receives the usual postpartum care only. Participants will be recruited through the postnatal wards at three regional public hospitals in Hong Kong. Eligible participants will be randomly assigned to either the telephone-based intervention or control group. The allocation schedule will be prepared in advanced using a restricted randomization scheme (random permutated blocks of six) by a random number table. The random numbers will be placed in sequentially numbered, opaque and sealed envelopes. After the women have given informed written consent at 2-3 days postpartum at the postnatal units, the research assistant will open the envelope containing the group assignment.
Participants will be postpartum women who meet the inclusion and exclusion criteria. The research nurse will determine if the women meet the sample inclusion criteria from their records. Potential eligible participants will be approached on the second or third postpartum day at the postnatal units. Women will be provided with essential information on the nature of the study and invited to complete the EPDS. Women who score above 9 on EPDS are considered at risk of postnatal depression and they will be invited to participate in the study. Verbal and written explanations of the purpose and the procedure of the study will be provided by the research nurse and written consent will be obtained from women who agree to participate in the study. Participants will be asked to complete the baseline measures, including EPDS and SF-12. Post-test measures will be collected at 6 weeks and 6 months postpartum through mail.
- Conditions
- Postnatal Depression
- Being tested
- telephone-based cognitive-behavioral intervention
- Keywords
- postnatal depression, quality of life
- Medical subject headings
- Depression, Postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
telephone-based cognitive-behavioral interventionBehavioural
The intervention is based on the cognitive-behavioral approach. It consists of five, 30-minutes sessions delivered weekly from postpartum week one to week five via telephone.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Not described |
| Telephone-based intervention | Experimental | Not described Receives: Behavioral: telephone-based cognitive-behavioral intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in depressive symptoms
change from baseline depressive symptoms at 6 weeks postpartum and change from baseline depressive symptoms at 6 months postpartum
Measured: 6 weeks and 6 months postpartum
Secondary outcomes (1)
Change in quality of life
change from baseline quality of life at 6 weeks postpartum and change from baseline quality of life at 6 months postpartum
Measured: 6 weeks and 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 posted11 Jan 2012 (estimated)
- Study startJul 2012
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Postnatal DepressionStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 397 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01507649
- Sponsor's protocol ID
- 09101031
- Status last verified
- Dec 2015
- First submitted
- 3 Jan 2012
- Last updated
- 2 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ngai FW, Wong PW, Chung KF, Leung KY. The effect of a telephone-based cognitive behavioral therapy on quality of life: a randomized controlled trial. Arch Womens Ment Health. 2017 Jun;20(3):421-426. doi: 10.1007/s00737-017-0722-0. Epub 2017 Mar 30.
PubMed 28361441Ngai FW, Wong PW, Chung KF, Leung KY. The effect of telephone-based cognitive-behavioural therapy on parenting stress: A randomised controlled trial. J Psychosom Res. 2016 Jul;86:34-8. doi: 10.1016/j.jpsychores.2016.03.016. Epub 2016 Apr 16.
PubMed 27302544
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Telephone-based Cognitive-behavioral Intervention on Postnatal Depression: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01507649
- Acronym / sponsor ID
- 09101031
- Conditions
- Postnatal Depression
- Keywords
- postnatal depression, quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 397 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 11 Jan 2012 (estimated)
- 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.
Purpose: To evaluate the effectiveness of a telephone-based intervention using cognitive-behavioral approach in preventing postnatal depression and improving quality of life in first-time Chinese mothers.
Hypothesis: Women who receive the telephone-based cognitive-behavioral intervention will have a lower level of depressive symptoms (primary outcome) and a higher level of quality of life at 6 weeks and 6 months postpartum than those who receive the usual postpartum care.
Design and subjects: Randomized controlled trial is used. A sample of postpartum women with high risk of postnatal depression (EPDS > 9, n = 498) will be randomly assigned to either the experimental (n = 249) or the control groups (n = 249). The experimental group receives the intervention and the control group receives usual postpartum care.
Study instruments: EPDS and Medical Outcomes Study Short Form Health Survey (SF-12).
Interventions: The intervention is based on the cognitive-behavioral approach. It consists of five, 30-minutes sessions delivered weekly from postpartum week one to week five via telephone.
Main outcome measures and analysis: Outcomes on postnatal depression and quality of life will be measured by EPDS and SF-12, respectively, at 6 weeks and 6 months postpartum. A repeated-measures multivariate analysis of variance will be used to compare differences between two groups.
Detailed description
The aim of this study is to design, implement and evaluate a telephone-based intervention using cognitive-behavioral approach for first-time mothers during the immediate postpartum period. The objective is to evaluate the effect of a telephone-based intervention using cognitive-behavioral approach on postnatal depression and quality of life at 6 weeks and 6 months postpartum.
A longitudinal, randomized, pre and post-test control group design will be used. This design involves providing a 5-week telephone-based intervention using cognitive-behavioral approach at the immediate postpartum period (first five weeks postpartum) to women with high risk of postnatal depression. The experimental group receives the intervention on top of the usual postpartum care, while the control group receives the usual postpartum care only. Participants will be recruited through the postnatal wards at three regional public hospitals in Hong Kong. Eligible participants will be randomly assigned to either the telephone-based intervention or control group. The allocation schedule will be prepared in advanced using a restricted randomization scheme (random permutated blocks of six) by a random number table. The random numbers will be placed in sequentially numbered, opaque and sealed envelopes. After the women have given informed written consent at 2-3 days postpartum at the postnatal units, the research assistant will open the envelope containing the group assignment.
Participants will be postpartum women who meet the inclusion and exclusion criteria. The research nurse will determine if the women meet the sample inclusion criteria from their records. Potential eligible participants will be approached on the second or third postpartum day at the postnatal units. Women will be provided with essential information on the nature of the study and invited to complete the EPDS. Women who score above 9 on EPDS are considered at risk of postnatal depression and they will be invited to participate in the study. Verbal and written explanations of the purpose and the procedure of the study will be provided by the research nurse and written consent will be obtained from women who agree to participate in the study. Participants will be asked to complete the baseline measures, including EPDS and SF-12. Post-test measures will be collected at 6 weeks and 6 months postpartum through mail.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | – |
| Telephone-based intervention | Experimental | Behavioral: telephone-based cognitive-behavioral intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- aged 18 or above
- first-time mother
- have given birth to a single full-term healthy baby
- able to speak and read the Chinese language
- Hong Kong residents
Key exclusion criteria (4 listed)
- single
- having complications after delivery
- having regular follow up with psychiatrists
- currently taking antidepressant or antipsychotic drugs.
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 |
|---|---|---|
| telephone-based cognitive-behavioral interventionThe intervention is based on the cognitive-behavioral approach. It consists of five, 30-minutes sessions delivered weekly from postpartum week one to week five via telephone. | Behavioural | Telephone-based intervention |
Primary outcome
Change in depressive symptoms
Time frame: 6 weeks and 6 months postpartum
change from baseline depressive symptoms at 6 weeks postpartum and change from baseline depressive symptoms at 6 months postpartum
1 secondary outcome
Change in quality of life
Time frame: 6 weeks and 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 2 Dec 2015.
- Derived from this study: PubMed 28361441Ngai FW, Wong PW, Chung KF, Leung KY. The effect of a telephone-based cognitive behavioral therapy on quality of life: a randomized controlled trial. Arch Womens Ment Health. 2017 Jun;20(3):421-426. doi: 10.1007/s00737-017-0722-0. Epub 2017 Mar 30.
- Derived from this study: PubMed 27302544Ngai FW, Wong PW, Chung KF, Leung KY. The effect of telephone-based cognitive-behavioural therapy on parenting stress: A randomised controlled trial. J Psychosom Res. 2016 Jul;86:34-8. doi: 10.1016/j.jpsychores.2016.03.016. Epub 2016 Apr 16.
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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 telephone-based cognitive-behavioral intervention in people with Postnatal Depression, run by The University of Hong Kong 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 6 inclusion and 4 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 2 Dec 2015. 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?
Change in depressive symptoms (time frame: 6 weeks and 6 months postpartum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01507649, which also lists 2 linked publications.
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 2 Dec 2015.