Exploratory Trial of a Group Psychological Intervention for Postnatal Depression in British Mother's of South Asian Origin

Depression, Postpartum Clinical Trial

— ROSHNI-D  

Official title:

Exploratory RCT of a Group Psychological Intervention for Postnatal Depression in British Mother's of South Asian Origin

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01838889
• Other study ID #: 47847
• Secondary ID: PB-PG-1208-18087
• Status: Completed
• Phase: N/A
• First received: April 14, 2013
• Last updated: December 5, 2014
• Start date: March 2011
• Est. completion date: October 2013

Study information

• Verified date: December 2014
• Source: Lancashire Care NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics CommitteeUnited Kingdom: National Institute for Health Research
• Study type: Interventional

Clinical Trial Summary

This study is an exploratory randomized controlled trial (RCT) of a group psychological intervention for postnatal depression in British mother's of south Asian origin. The aim is to evaluate the efficacy of a group psychological intervention (PHP) based on the principles of Cognitive Behaviour Therapy in treating depression in postpartum women. The hypothesis is that depressed British women of South Asian origin receiving the group intervention will show significant improvements in terms of severity of depression as compared to the treatment as usual (TAU) control group.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 83
• Est. completion date: October 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

• self-ascribed British women of South Asian origin as defined by UK Office of -National Statistics,

• over the age of 16 years

• living with their babies,

• who meet the criteria for ICD-10 depression

Exclusion Criteria:

• women with diagnosed physical or learning disability,

• post-partum or other psychosis,

• severely depressed

• actively suicidal.

Study Design

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

Related Conditions & MeSH terms

• Depression
• Depression, Postpartum
• Depressive Disorder
• Postnatal Depression in British South Asian Women

Intervention

Behavioral:
• Culturally adapted psychological intervention (Positive Health Programme)
This study will evaluate the efficacy of a group psychological intervention (PHP) based on the principles of Cognitive Behaviour Therapy in treating depression in postpartum women.

Locations

Country	Name	City	State
United Kingdom	Primary Care; Mother and Baby Clinics	Borough of Blackburn with Darwen; Burnley; Preston; Manchester	Lancashire, Greater Manchester

Sponsors (2)

Lead Sponsor	Collaborator
Lancashire Care NHS Foundation Trust	University of Manchester

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Revised Clinical Interview Schedule (CIS-R)	Tool used to confirm the diagnosis of depression.	Assessment done at baseline	No
Primary	Edinburgh Post Natal Depression Scale (EPDS; Cox et al 1987)		Assessments will be carried out at baseline, 3 months (end of intervention) and 6 months (The primary end point is 3 months).	No
Secondary	EuroQoL-5 Dimensions (EQ-5D)		Assessments will be carried out at baseline, 3 months (end of intervention) and 6 months (The primary end point is 3 months)	No
Secondary	The Parenting Stress Index (PSI)		Assessments will be carried out at baseline, 3 months (end of intervention) and 6 months (The primary end point is 3 months)	No
Secondary	Multidimensional Scale of Perceived Social Support (MSPSS)		Assessments will be carried out at baseline, 3 months (end of intervention) and 6 months (The primary end point is 3 months)	No
Secondary	Dyadic Adjustment Scale (DAS)		Assessments will be carried out at baseline, 3 months (end of intervention) and 6 months (The primary end point is 3 months)	No
Secondary	Home Inventory (HI)		Assessments will be carried out at baseline, 3 months (end of intervention) and 6 months (The primary end point is 3 months)	No
Secondary	Hamilton Rating Scale for Depression (HRSD)		Assessments will be carried out at baseline, 3 months (end of intervention) and 6 months (The primary end point is 3 months)	No
Secondary	Client Service Receipt Inventory (CSRI)		Assessments will be carried out at baseline, 3 months (end of intervention) and 6 months (The primary end point is 3 months)	No