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Randomised Control Trial of a Complex Intervention for Postnatal Depression

This study has been completed.
Sponsor:
Collaborators:
Dow University of Health Sciences
University of Manchester
Information provided by (Responsible Party):
Pakistan Institute of Learning and Living
ClinicalTrials.gov Identifier:
NCT01309516
First received: January 22, 2011
Last updated: September 19, 2015
Last verified: September 2015

January 22, 2011
September 19, 2015
May 2009
December 2010   (final data collection date for primary outcome measure)
  • Depression [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    We will measure change from baseline in symptoms of depression through Hamilton Depression Rating Scale (HDRS) at six months by using 17 item HDRS.
  • Postnatal Depression [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Edinburgh Postnatal Depression Scale (EPDS) will be used to identify mothers with postnatal depression.
  • 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.
Complete list of historical versions of study NCT01309516 on ClinicalTrials.gov Archive Site
  • 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
  • Social Support [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Social support of participants will be measured with OSLO 3-Items Social Support Scale
  • health related quality of life [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    EuroQol-5D(EQ-5 D) will be used to 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 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Maternal attachment with infants will be measured with Maternal Attachment Inventory (MAI)
  • 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
Not Provided
Not Provided
 
Randomised Control Trial of a Complex Intervention for Postnatal Depression
Efficacy of Learning Through Play Plus Intervention to Reduce Maternal Depression for Women With Under-nourished Children: A Randomized Controlled Trial From Pakistan

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).

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Postnatal Depression
  • Depression, Postpartum
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
  • Experimental: Complex Intervention (LTP-TH)
    The 12 sessions of complex intervention (LTP-TH) will be delivered to mothers.
    Intervention: Behavioral: Complex Intervention
  • No Intervention: Control group
    Control group will receive standard postnatal follow-up.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
107
May 2011
December 2010   (final data collection date for primary outcome measure)

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
Female
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Pakistan
 
NCT01309516
pill110409
No
Not Provided
Not Provided
Pakistan Institute of Learning and Living
Pakistan Institute of Learning and Living
  • Dow University of Health Sciences
  • University of Manchester
Principal Investigator: Nusrat Husain, MD University of Manchester
Pakistan Institute of Learning and Living
September 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP