NCT01309516

Brief Summary

The study aims to:

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
107

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started May 2009

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2009

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 22, 2011

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 7, 2011

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
Last Updated

September 22, 2015

Status Verified

September 1, 2015

Enrollment Period

1.6 years

First QC Date

January 22, 2011

Last Update Submit

September 19, 2015

Conditions

Postnatal DepressionDepression, Postpartum

Keywords

Postnatal depressionMaternal depressionPsychosocial intervention

Outcome Measures

Primary Outcomes (2)

  • Depression

    We will measure change from baseline in symptoms of depression through Hamilton Depression Rating Scale (HDRS) at six months by using 17 item HDRS.

    6 months

  • Postnatal Depression

    Edinburgh Postnatal Depression Scale (EPDS) will be used to identify mothers with postnatal depression.

    6 months

Secondary Outcomes (5)

  • Infants' weight

    6 months

  • Infants' height

    6 months

  • Social Support

    6 months

  • health related quality of life

    6 months

  • Maternal Attachment

    6 months

Study Arms (2)

Complex Intervention (LTP-TH)

EXPERIMENTAL

The 12 sessions of complex intervention (LTP-TH) will be delivered to mothers.

Behavioral: Complex Intervention

Control group

NO INTERVENTION

Control group will receive standard postnatal follow-up.

Interventions

Complex InterventionBEHAVIORAL

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

Also known as: Multimodal Psychosocial Intervention
Complex Intervention (LTP-TH)

Eligibility Criteria

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

You may qualify if:

  • Depressed mothers over the age of 18 years
  • Having one or more infants 6-18 months old
  • Ability to give informed consent
  • Resident in the study catchment area

You may not qualify if:

  • Women or child with diagnosed physical or learning disability and women having post-partum or other psychosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Civil hospital

Karachi, Sindh, 75600, Pakistan

Location

Abbasi Shaheed hospital Karachi

Karachi, Sindh, Pakistan

Location

Related Links

MeSH Terms

Conditions

Depression, Postpartum

Condition Hierarchy (Ancestors)

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

Study Officials

  • Nusrat Husain, MD

    University of Manchester

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 22, 2011

First Posted

March 7, 2011

Study Start

May 1, 2009

Primary Completion

December 1, 2010

Study Completion

May 1, 2011

Last Updated

September 22, 2015

Record last verified: 2015-09

Locations

PA(2)