Skip to main content
OpenTrials
Completed

NCT Number: NCT01309516

Randomised Control Trial of a Complex Intervention for Postnatal Depression

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).

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Abbasi Shaheed hospital Karachi, Karachi, Sindh, Pakistan

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Complex intervention

Behavioral

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

Other names: Multimodal Psychosocial Intervention

Primary outcomes

  1. Depression

    Time frame: 6 months

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

  2. Postnatal Depression

    Time frame: 6 months

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

Secondary outcomes

  1. Infants' weight

    Time frame: 6 months

    Will be measured through standard anthropometric techniques and equipments

  2. Infants' height

    Time frame: 6 months

    Will be measured through standard anthropometric techniques and equipments

  3. Social Support

    Time frame: 6 months

    Social support of participants will be measured with OSLO 3-Items Social Support Scale

  4. health related quality of life

    Time frame: 6 months

    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.

  5. Maternal Attachment

    Time frame: 6 months

    Maternal attachment with infants will be measured with Maternal Attachment Inventory (MAI)

Sponsors and collaborators

Lead sponsor

Pakistan Institute of Living and Learning

Other

Collaborators

  • Dow University of Health Sciences
  • University of Manchester

Registry information

Official study title

Efficacy of Learning Through Play Plus Intervention to Reduce Maternal Depression for Women With Under-nourished Children: A Randomized Controlled Trial From Pakistan

Important dates

Study start
2009
Primary completion
2010
Study completion
2011
First posted
Mar 7, 2011
Registry last updated
Sep 22, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.