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Randomised Control Trial of a Complex Intervention for Postnatal Depression

NCT01309516 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 107

Last updated 2015-09-22

No results posted yet for this study

Summary

The study aims to:

1. Develop a culturally appropriate psychosocial intervention
2. Test feasibility and acceptability of psychosocial intervention in women suffering from postnatal depression.

Primary Hypothesis:

Depressed mothers who will receive the group intervention will show significant improvements in terms of symptoms of depression.

Design:

Randomised controlled trial.

Setting:

Outpatient department of Civil hospital Karachi.

Participants:

A total of 84 depressed mothers will be randomised equally to an intervention group and a Treatment as usual control group.

Interventions:

The 12 session multimodal psychosocial intervention will be delivered to mothers in the intervention group over a three months period. Each session would take up to 45 minutes. Control group will receive standard postnatal follow-up.

Outcome measures:

Primary outcome measures would be mothers' scores on Edinburgh Postnatal Depression Scale (EPDS)and Hamilton Depression Rating Scale (HDRS).

Conditions

  • Postnatal Depression
  • Depression, Postpartum

Interventions

BEHAVIORAL

Complex Intervention

This 12 session Multimodal Psychosocial Intervention will include a supportive component, an educational component, psychosocial component and a parenting programme.

Sponsors & Collaborators

  • Dow University of Health Sciences

    collaborator OTHER

  • University of Manchester

    collaborator OTHER

  • Pakistan Institute of Living and Learning

    lead OTHER

Principal Investigators

  • Nusrat Husain, MD · University of Manchester

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-05-31
Primary Completion
2010-12-31
Completion
2011-05-31

Countries

  • Pakistan

Study Locations

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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 NCT01309516 on ClinicalTrials.gov