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Effect of a Telephone-based Intervention on Postnatal Depression

NCT01507649 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 397

Last updated 2015-12-02

No results posted yet for this study

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.

Conditions

  • Postnatal Depression

Interventions

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.

Sponsors & Collaborators

  • The University of Hong Kong

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-07-31
Primary Completion
2014-12-31
Completion
2014-12-31

Countries

  • Hong Kong

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01507649 on ClinicalTrials.gov