Randomised Control Trial of a Complex Intervention for Postnatal Depression

Study Description

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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).

Condition or disease	Intervention/treatment	Phase
Postnatal Depression; Depression, Postpartum	Behavioral: Complex Intervention	Phase 2

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.

Study Design

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	107 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Single (Outcomes Assessor)
Primary Purpose:	Treatment
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 Start Date :	May 2009
Actual Primary Completion Date :	December 2010
Actual Study Completion Date :	May 2011

Arms and Interventions

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
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.

Outcome Measures

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Depression [ Time Frame: 6 months ]
   We will measure change from baseline in symptoms of depression through Hamilton Depression Rating Scale (HDRS) at six months by using 17 item HDRS.
2. Postnatal Depression [ Time Frame: 6 months ]
   Edinburgh Postnatal Depression Scale (EPDS) will be used to identify mothers with postnatal depression.

Secondary Outcome Measures :

1. Infants' weight [ Time Frame: 6 months ]
   Will be measured through standard anthropometric techniques and equipments
2. Infants' height [ Time Frame: 6 months ]
   Will be measured through standard anthropometric techniques and equipments
3. Social Support [ Time Frame: 6 months ]
   Social support of participants will be measured with OSLO 3-Items Social Support Scale
4. health related quality of life [ Time Frame: 6 months ]
   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.
5. Maternal Attachment [ Time Frame: 6 months ]
   Maternal attachment with infants will be measured with Maternal Attachment Inventory (MAI)

Eligibility Criteria

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

Pakistan
Civil hospital
Karachi, Sindh, Pakistan, 75600
Abbasi Shaheed hospital Karachi
Karachi, Sindh, Pakistan

Sponsors and Collaborators

Pakistan Institute of Learning and Living

Dow University of Health Sciences

University of Manchester

Investigators

Principal Investigator:	Nusrat Husain, MD	University of Manchester

More Information

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

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

Responsible Party:	Pakistan Institute of Learning and Living
ClinicalTrials.gov Identifier:	NCT01309516 History of Changes
Other Study ID Numbers:	pill110409
First Posted:	March 7, 2011
Last Update Posted:	September 22, 2015
Last Verified:	September 2015

Keywords provided by Pakistan Institute of Learning and Living:

Postnatal depression; Maternal depression; Psychosocial intervention

Additional relevant MeSH terms:

Depression; Depressive Disorder; Depression, Postpartum; Behavioral Symptoms	Mood Disorders; Mental Disorders; Puerperal Disorders; Pregnancy Complications