Effect of a Telephone-based Intervention on Postnatal Depression

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by The University of Hong Kong.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
The University of Hong Kong
ClinicalTrials.gov Identifier:
NCT01507649
First received: January 3, 2012
Last updated: January 6, 2012
Last verified: January 2012
  Purpose

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 Intervention
Postnatal Depression
Behavioral: telephone-based cognitive-behavioral intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Effect of a Telephone-based Cognitive-behavioral Intervention on Postnatal Depression: a Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by The University of Hong Kong:

Primary Outcome Measures:
  • Change in depressive symptoms [ Time Frame: 6 weeks and 6 months postpartum ] [ Designated as safety issue: No ]
    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 [ Time Frame: 6 weeks and 6 months postpartum ] [ Designated as safety issue: No ]
    change from baseline quality of life at 6 weeks postpartum and change from baseline quality of life at 6 months postpartum


Estimated Enrollment: 498
Study Start Date: February 2012
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01507649

Locations
Hong Kong
The University of Hong Kong Not yet recruiting
Hong Kong, Hong Kong
Contact: Ngai       fwngai@hku.hk   
Principal Investigator: Fei Wan Ngai, PhD         
Sponsors and Collaborators
The University of Hong Kong
  More Information

No publications provided

Responsible Party: The University of Hong Kong
ClinicalTrials.gov Identifier: NCT01507649     History of Changes
Other Study ID Numbers: 09101031
Study First Received: January 3, 2012
Last Updated: January 6, 2012
Health Authority: Hong Kong: Ethics Committee

Keywords provided by The University of Hong Kong:
postnatal depression
quality of life

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depression, Postpartum
Behavioral Symptoms
Mood Disorders
Mental Disorders
Puerperal Disorders
Pregnancy Complications

ClinicalTrials.gov processed this record on July 20, 2014