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

Study Overview
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Brief Summary
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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.

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

Conditions
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Depression, Postpartum, Postnatal Depression in British South Asian Women

Intervention / Treatment
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* Behavioral: Culturally adapted psychological intervention (Positive Health Programme)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Culturally adapted psychological intervention (PHP)<br>Depressed Mothers randomized to experimental arm will undergo a 12 week group psychological intervention on the 'positive health programme'. | Behavioral: Culturally adapted psychological intervention (Positive Health Programme)<br>* 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.<br>* Other names: PHP;|
| No Intervention: Treatment as usual (TAU)<br>Depressed mothers randomized to TAU arm will receive treatment as usual. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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) | 
| 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) | 
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Culturally adapted, Group psychological intervention, British South Asian women, CBT