Clinical trial NCT01309516: Randomised Control Trial of a Complex Intervention for Postnatal Depression
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Postnatal Depression
Depression, Postpartum
Keywords: Postnatal depression
Maternal depression
Psychosocial intervention
Lead sponsor: Pakistan Institute of Living and Learning
Sponsor class: OTHER
Collaborators: name: Dow University of Health Sciences
name: University of Manchester
First posted: 2011-03-07
Enrollment: 107
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

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 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

Primary outcomes:
measure: Depression
timeFrame: 6 months
measure: Postnatal Depression
timeFrame: 6 months
Secondary outcomes:
measure: Infants' weight
timeFrame: 6 months
measure: Infants' height
timeFrame: 6 months
measure: Social Support
timeFrame: 6 months
measure: health related quality of life
timeFrame: 6 months
measure: Maternal Attachment
timeFrame: 6 months
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Civil hospital
state: Sindh
city: Karachi
country: Pakistan
facility: Abbasi Shaheed hospital Karachi
state: Sindh
Study officials:
affiliation: University of Manchester
name: Nusrat Husain, MD
role: PRINCIPAL_INVESTIGATOR
References: