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

Not Applicable

Completed

• Conditions: Depression, Postpartum; Postnatal Depression in British South Asian Women

• Registration Number: NCT01838889
• Lead Sponsor: Lancashire Care NHS Foundation Trust

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-03
• Study First Submitted: 2013-04-14
• Study First Submitted QC: 2013-04-19
• Study First Posted: 2013-04-24
• Primary Completion: 2013-08
• Study Completion: 2013-10
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-05
• Last Update Posted: 2014-12-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 83

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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).

Secondary Outcome Measures

Name	Time	Method
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)
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)
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)
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)
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)
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)
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)

Trial Locations

Locations (1)

Primary Care; Mother and Baby Clinics; 🇬🇧 Borough of Blackburn with Darwen; Burnley; Preston; Manchester, Lancashire, Greater Manchester, United Kingdom

Primary Care; Mother and Baby Clinics

🇬🇧Borough of Blackburn with Darwen; Burnley; Preston; Manchester, Lancashire, Greater Manchester, United Kingdom