Clinical trial NCT01838889: Exploratory Trial of a Group Psychological Intervention for Postnatal Depression in British Mother's of South Asian Origin
Official title: Exploratory RCT of a Group Psychological Intervention for Postnatal Depression in British Mother's of South Asian Origin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression, Postpartum
Postnatal Depression in British South Asian Women
Keywords: Culturally adapted
Group psychological intervention
British South Asian women
CBT
Lead sponsor: Lancashire Care NHS Foundation Trust
Sponsor class: NETWORK
Collaborators: name: University of Manchester
First posted: 2013-04-24
Enrollment: 83
Sex: FEMALE
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Edinburgh Post Natal Depression Scale (EPDS; Cox et al 1987)
timeFrame: Assessments will be carried out at baseline, 3 months (end of intervention) and 6 months (The primary end point is 3 months).
Secondary outcomes:
measure: EuroQoL-5 Dimensions (EQ-5D)
timeFrame: Assessments will be carried out at baseline, 3 months (end of intervention) and 6 months (The primary end point is 3 months)
measure: The Parenting Stress Index (PSI)
timeFrame: Assessments will be carried out at baseline, 3 months (end of intervention) and 6 months (The primary end point is 3 months)
measure: Multidimensional Scale of Perceived Social Support (MSPSS)
timeFrame: Assessments will be carried out at baseline, 3 months (end of intervention) and 6 months (The primary end point is 3 months)
measure: Dyadic Adjustment Scale (DAS)
timeFrame: Assessments will be carried out at baseline, 3 months (end of intervention) and 6 months (The primary end point is 3 months)
measure: Home Inventory (HI)
timeFrame: Assessments will be carried out at baseline, 3 months (end of intervention) and 6 months (The primary end point is 3 months)
measure: Hamilton Rating Scale for Depression (HRSD)
timeFrame: Assessments will be carried out at baseline, 3 months (end of intervention) and 6 months (The primary end point is 3 months)
measure: Client Service Receipt Inventory (CSRI)
timeFrame: Assessments will be carried out at baseline, 3 months (end of intervention) and 6 months (The primary end point is 3 months)
Other outcomes:
measure: Revised Clinical Interview Schedule (CIS-R)
timeFrame: Assessment done at baseline
Locations:
city: Borough of Blackburn with Darwen; Burnley; Preston; Manchester
country: United Kingdom
facility: Primary Care; Mother and Baby Clinics
state: Lancashire, Greater Manchester
Study officials:
References:
citation: Masood Y, Lovell K, Lunat F, Atif N, Waheed W, Rahman A, Mossabir R, Chaudhry N, Husain N. Group psychological intervention for postnatal depression: a nested qualitative study with British South Asian women. BMC Womens Health. 2015 Nov 25;15:109. doi: 10.1186/s12905-015-0263-5.