NCT01507649

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
397

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 3, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 11, 2012

Completed
6 months until next milestone

Study Start

First participant enrolled

July 1, 2012

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

December 2, 2015

Status Verified

December 1, 2015

Enrollment Period

2.4 years

First QC Date

January 3, 2012

Last Update Submit

December 1, 2015

Conditions

Postnatal Depression

Keywords

postnatal depressionquality of life

Outcome Measures

Primary Outcomes (1)

  • Change in depressive symptoms

    change from baseline depressive symptoms at 6 weeks postpartum and change from baseline depressive symptoms at 6 months postpartum

    6 weeks and 6 months postpartum

Secondary Outcomes (1)

  • Change in quality of life

    6 weeks and 6 months postpartum

Study Arms (2)

Control

NO INTERVENTION

Telephone-based intervention

EXPERIMENTAL
Behavioral: telephone-based cognitive-behavioral intervention

Interventions

telephone-based cognitive-behavioral interventionBEHAVIORAL

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.

Telephone-based intervention

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • single
  • having complications after delivery
  • having regular follow up with psychiatrists
  • currently taking antidepressant or antipsychotic drugs.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Hong Kong

Hong Kong, Hong Kong

Location

Related Publications (2)

  • 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.

    PMID: 28361441DERIVED

  • 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.

    PMID: 27302544DERIVED

MeSH Terms

Conditions

Depression, Postpartum

Condition Hierarchy (Ancestors)

Puerperal DisordersPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDepressive DisorderMood DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 3, 2012

First Posted

January 11, 2012

Study Start

July 1, 2012

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

December 2, 2015

Record last verified: 2015-12

Locations

HK(1)