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Trial for Postnatal Depression

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by Pakistan Institute of Learning and Living.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Dow University of Health Sciences
University of Manchester
Information provided by:
Pakistan Institute of Learning and Living
ClinicalTrials.gov Identifier:
NCT01309516
First received: January 22, 2011
Last updated: March 4, 2011
Last verified: March 2011
  Purpose

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).


Condition Intervention Phase
Postnatal Depression
Depression, Postpartum
Behavioral: Complex Intervention
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomised Control Trial of a Complex Intervention for Postnatal Depression

Resource links provided by NLM:


Further study details as provided by Pakistan Institute of Learning and Living:

Primary Outcome Measures:
  • Hamilton Depression Rating Scale (HDRS) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    We will measure change from baseline in symptoms of depression at six months by using 17 item HDRS.

  • Edinburgh Postnatal Depression Scale (EPDS) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    This is 10 item self report questionnaire with four possible responses used to identify mothers with postnatal depression.


Secondary Outcome Measures:
  • Infants' weight [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Will be measured through standard anthropometric techniques and equipments

  • Infants' height [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Will be measured through standard anthropometric techniques and equipments

  • OSLO 3-Items Social Support Scale [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    This is a 3 item scale which measures social support of participants from family, friends and neighbourhood

  • EuroQol-5D(EQ-5 D) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    This instrument measures health related quality of life in five dimensions. It provides a simple descriptive profile and a single index value for health status.

  • Maternal Attachment Inventory (MAI) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    It is a 26 item scale that measures maternal attachment with infants


Estimated Enrollment: 84
Study Start Date: May 2009
Estimated Study Completion Date: May 2011
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Complex Intervention (LTP-TH)
The 12 sessions of complex intervention (LTP-TH) will be delivered to mothers.
Behavioral: Complex Intervention
This 12 session Multimodal Psychosocial Intervention will include a supportive component, an educational component, psychosocial component and a parenting programme.
Other Name: Multimodal Psychosocial Intervention
No Intervention: Control group
Control group will receive standard postnatal follow-up.

Detailed Description:

A number of individual and group interventions targeting maternal depression have been developed and tested, mostly in developed countries. Group-based approaches have usually been used to improve outcomes in children through parent-training programmes. A meta-analysis of such programmes shows that these can also be effective in improving psychosocial and mental health of the mothers. However, a number of health system and cultural differences make it difficult for mental health interventions to be extrapolated from the developed to the developing world.

Design:

The interventions will be assessed using a prospective randomised controlled design, using two groups: psychosocial group therapy (Learning Through Play + principles of Cognitive Behaviour Therapy)and treatment as usual.

Defining the intervention:

The intervention will include a supportive component, an educational component, and practical advice on using health services, a parenting component, and a psychosocial component. The objective will be to help mothers feel supported, empowered and confident about their parenting abilities, which in turn may help to reduce their level of depression. Further qualitative testing of the intervention will take place to refine the manualized intervention.

Psychiatric Measures:

The level of severity of depression will be assessed using the Edinburgh Postnatal Depression Scale (EPDS) (Cox and Holden, 1994) and the Hamilton Depression Rating Scale (HDRS) (Hamilton, 1960).

Women scoring 12 or over on the EPDS and 13 or over on the HDRS will be asked to undergo a diagnostic interview using the Clinical Interview Schedule-Revised (CIS-R).

To measure mother infant attachment the Maternal Attachment Inventory (Muller, 1994) will be used.

OSLO-3 item Social Support Scale (Dalgard, 1996) will be used to measure social support.

The adapted Verona Service Satisfaction Scale (Tansella, 1991) will be used to measure patient satisfaction with support and treatment.

Quality of life will be measured by using the EuroQol-5D (EQ-5D).

The qualitative interviews will be used to elicit information about previous attempts for help with mental health issues and questions regarding participants understanding of their postnatal depression and their future expectations from a perinatal service.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Women or child with diagnosed physical or learning disability and women having post-partum or other psychosis
  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: NCT01309516

Contacts
Contact: Nusrat Husain, MD +44 1254 226394 nusrat.husain@manchester.ac.uk
Contact: Imran Chaudhry, MD +44 1254 226392 imran.chaudhry@manchester.ac.uk

Locations
Pakistan
Civil hospital Recruiting
Karachi, Sindh, Pakistan, 75600
Contact: Inkisar Ali    +923332148192    inkisarali@yahoo.com   
Contact: Raza Rahman    +92 3002579364    razaur@yahoo.com   
Sponsors and Collaborators
Pakistan Institute of Learning and Living
Dow University of Health Sciences
University of Manchester
Investigators
Principal Investigator: Nusrat Husain, MD University of Manchester
  More Information

Additional Information:
No publications provided

Responsible Party: Dr Nusrat Husain, University Of Manchester
ClinicalTrials.gov Identifier: NCT01309516     History of Changes
Other Study ID Numbers: pill110409
Study First Received: January 22, 2011
Last Updated: March 4, 2011
Health Authority: Pakistan: Ministry of Health

Keywords provided by Pakistan Institute of Learning and Living:
Postnatal depression
Maternal depression
Psychosocial intervention

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

ClinicalTrials.gov processed this record on October 29, 2014