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