Randomised Control Trial of a Complex Intervention for Postnatal Depression
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).
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.
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