Effect of a Telephone-based Intervention on Postnatal Depression
Primary Purpose
Postnatal Depression
Status
Completed
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
telephone-based cognitive-behavioral intervention
Sponsored by
About this trial
This is an interventional prevention trial for Postnatal Depression focused on measuring postnatal depression, quality of life
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- single
- having complications after delivery
- having regular follow up with psychiatrists
- currently taking antidepressant or antipsychotic drugs.
Sites / Locations
- The University of Hong Kong
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control
Telephone-based intervention
Arm Description
Outcomes
Primary Outcome Measures
Change in depressive symptoms
change from baseline depressive symptoms at 6 weeks postpartum and change from baseline depressive symptoms at 6 months postpartum
Secondary Outcome Measures
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
Full Information
NCT ID
NCT01507649
First Posted
January 3, 2012
Last Updated
December 1, 2015
Sponsor
The University of Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT01507649
Brief Title
Effect of a Telephone-based Intervention on Postnatal Depression
Official Title
The Effect of a Telephone-based Cognitive-behavioral Intervention on Postnatal Depression: a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The University of Hong Kong
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postnatal Depression
Keywords
postnatal depression, quality of life
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
397 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Title
Telephone-based intervention
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
telephone-based cognitive-behavioral intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in depressive symptoms
Description
change from baseline depressive symptoms at 6 weeks postpartum and change from baseline depressive symptoms at 6 months postpartum
Time Frame
6 weeks and 6 months postpartum
Secondary Outcome Measure Information:
Title
Change in quality of life
Description
change from baseline quality of life at 6 weeks postpartum and change from baseline quality of life at 6 months postpartum
Time Frame
6 weeks and 6 months postpartum
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
single
having complications after delivery
having regular follow up with psychiatrists
currently taking antidepressant or antipsychotic drugs.
Facility Information:
Facility Name
The University of Hong Kong
City
Hong Kong
Country
Hong Kong
12. IPD Sharing Statement
Citations:
PubMed Identifier
28361441
Citation
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.
Results Reference
derived
PubMed Identifier
27302544
Citation
Ngai 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.
Results Reference
derived
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Effect of a Telephone-based Intervention on Postnatal Depression
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