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

Lancashire Care NHS Foundation Trust1 site in 1 country83 target enrollmentMarch 2011

ConditionsDepression, Postpartum Postnatal Depression in British South Asian Women

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Depression, Postpartum
Sponsor: Lancashire Care NHS Foundation Trust
Enrollment: 83
Locations: 1
Primary Endpoint: Edinburgh Post Natal Depression Scale (EPDS; Cox et al 1987)
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

March 2011

End Date

October 2013

Last Updated

11 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

Lancashire Care NHS Foundation Trust

Responsible Party

Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Edinburgh Post Natal Depression Scale (EPDS; Cox et al 1987)

Time Frame: Assessments will be carried out at baseline, 3 months (end of intervention) and 6 months (The primary end point is 3 months).

Secondary Outcomes

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))
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))
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))
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))
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))
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))