Randomised Control Trial of a Complex Intervention for Postnatal Depression

Depression, Postpartum Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01309516
• Other study ID #: pill110409
• Status: Completed
• Phase: Phase 2
• First received: January 22, 2011
• Last updated: September 19, 2015
• Start date: May 2009
• Est. completion date: May 2011

Study information

• Verified date: September 2015
• Source: Pakistan Institute of Learning and Living
• Contact: n/a
• Is FDA regulated: No
• Health authority: Pakistan: Ministry of Health
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 107
• Est. completion date: May 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depression, Postpartum
• Depressive Disorder
• Postnatal Depression

Intervention

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

Locations

Country	Name	City	State
Pakistan	Abbasi Shaheed hospital Karachi	Karachi	Sindh
Pakistan	Civil hospital	Karachi	Sindh

Sponsors (3)

Lead Sponsor	Collaborator
Pakistan Institute of Learning and Living	Dow University of Health Sciences, University of Manchester

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	Postnatal Depression	Edinburgh Postnatal Depression Scale (EPDS) will be used to identify mothers with postnatal depression.	6 months	No
Secondary	Infants' weight	Will be measured through standard anthropometric techniques and equipments	6 months	No
Secondary	Infants' height	Will be measured through standard anthropometric techniques and equipments	6 months	No
Secondary	Social Support	Social support of participants will be measured with OSLO 3-Items Social Support Scale	6 months	No
Secondary	health related quality of life	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.	6 months	No
Secondary	Maternal Attachment	Maternal attachment with infants will be measured with Maternal Attachment Inventory (MAI)	6 months	No

External Links

•   Pakistan Institute of Learning & Living, Organization (Collaborator) offering logistic and technical support.