Effect of a Telephone-based Intervention on Postnatal Depression
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01507649|
Recruitment Status : Completed
First Posted : January 11, 2012
Last Update Posted : December 2, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Postnatal Depression||Behavioral: telephone-based cognitive-behavioral intervention||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||397 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||The Effect of a Telephone-based Cognitive-behavioral Intervention on Postnatal Depression: a Randomized Controlled Trial|
|Study Start Date :||July 2012|
|Actual Primary Completion Date :||December 2014|
|Actual Study Completion Date :||December 2014|
|No Intervention: Control|
|Experimental: Telephone-based intervention||
Behavioral: telephone-based cognitive-behavioral intervention
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.
- 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
- Change in quality of life [ Time Frame: 6 weeks and 6 months postpartum ]change from baseline quality of life at 6 weeks postpartum and change from baseline quality of life at 6 months postpartum
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01507649
|The University of Hong Kong|
|Hong Kong, Hong Kong|