Trial for Postnatal Depression
Recruitment status was Recruiting
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Purpose
The study aims to:
- Develop a culturally appropriate psychosocial intervention
- 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).
| Condition | Intervention | Phase |
|---|---|---|
|
Postnatal Depression Depression, Postpartum |
Behavioral: Complex Intervention |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Randomised Control Trial of a Complex Intervention for Postnatal Depression |
- Hamilton Depression Rating Scale (HDRS) [ Time Frame: 6 months ] [ Designated as safety issue: No ]We will measure change from baseline in symptoms of depression at six months by using 17 item HDRS.
- Edinburgh Postnatal Depression Scale (EPDS) [ Time Frame: 6 months ] [ Designated as safety issue: No ]This is 10 item self report questionnaire with four possible responses used to identify mothers with postnatal depression.
- Infants' weight [ Time Frame: 6 months ] [ Designated as safety issue: No ]Will be measured through standard anthropometric techniques and equipments
- Infants' height [ Time Frame: 6 months ] [ Designated as safety issue: No ]Will be measured through standard anthropometric techniques and equipments
- OSLO 3-Items Social Support Scale [ Time Frame: 6 months ] [ Designated as safety issue: No ]This is a 3 item scale which measures social support of participants from family, friends and neighbourhood
- EuroQol-5D(EQ-5 D) [ Time Frame: 6 months ] [ Designated as safety issue: No ]This instrument measures health related quality of life in five dimensions. It provides a simple descriptive profile and a single index value for health status.
- Maternal Attachment Inventory (MAI) [ Time Frame: 6 months ] [ Designated as safety issue: No ]It is a 26 item scale that measures maternal attachment with infants
| Estimated Enrollment: | 84 |
| Study Start Date: | May 2009 |
| Estimated Study Completion Date: | May 2011 |
| Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Complex Intervention (LTP-TH)
The 12 sessions of complex intervention (LTP-TH) will be delivered to mothers.
|
Behavioral: Complex Intervention
This 12 session Multimodal Psychosocial Intervention will include a supportive component, an educational component, psychosocial component and a parenting programme.
Other Name: Multimodal Psychosocial Intervention
|
|
No Intervention: Control group
Control group will receive standard postnatal follow-up.
|
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT01309516
| Contact: Nusrat Husain, MD | +44 1254 226394 | nusrat.husain@manchester.ac.uk | |
| Contact: Imran Chaudhry, MD | +44 1254 226392 | imran.chaudhry@manchester.ac.uk |
| Pakistan | |
| Civil hospital | Recruiting |
| Karachi, Sindh, Pakistan, 75600 | |
| Contact: Inkisar Ali +923332148192 inkisarali@yahoo.com | |
| Contact: Raza Rahman +92 3002579364 razaur@yahoo.com | |
| Principal Investigator: | Nusrat Husain, MD | University of Manchester |
More Information
Additional Information:
No publications provided
| Responsible Party: | Dr Nusrat Husain, University Of Manchester |
| ClinicalTrials.gov Identifier: | NCT01309516 History of Changes |
| Other Study ID Numbers: | pill110409 |
| Study First Received: | January 22, 2011 |
| Last Updated: | March 4, 2011 |
| Health Authority: | Pakistan: Ministry of Health |
Keywords provided by Pakistan Institute of Learning and Living:
|
Postnatal depression Maternal depression Psychosocial intervention |
Additional relevant MeSH terms:
|
Depression Depression, Postpartum Depressive Disorder Behavioral Symptoms |
Mental Disorders Mood Disorders Pregnancy Complications Puerperal Disorders |
ClinicalTrials.gov processed this record on March 02, 2015