Exploratory Trial of a Group Psychological Intervention for Postnatal Depression in British Mother's of South Asian Origin (ROSHNI-D)
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ClinicalTrials.gov Identifier: NCT01838889 |
Recruitment Status
:
Completed
First Posted
: April 24, 2013
Last Update Posted
: December 8, 2014
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Depression, Postpartum Postnatal Depression in British South Asian Women | Behavioral: Culturally adapted psychological intervention (Positive Health Programme) | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 83 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Exploratory RCT of a Group Psychological Intervention for Postnatal Depression in British Mother's of South Asian Origin |
Study Start Date : | March 2011 |
Actual Primary Completion Date : | August 2013 |
Actual Study Completion Date : | October 2013 |

Arm | Intervention/treatment |
---|---|
Experimental: Culturally adapted psychological intervention (PHP)
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)
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.
Other Name: PHP
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No Intervention: Treatment as usual (TAU)
Depressed mothers randomized to TAU arm will receive treatment as usual.
|
- 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). ]
- EuroQoL-5 Dimensions (EQ-5D) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: Assessments will be carried out at baseline, 3 months (end of intervention) and 6 months (The primary end point is 3 months) ]
- Revised Clinical Interview Schedule (CIS-R) [ Time Frame: Assessment done at baseline ]Tool used to confirm the diagnosis of depression.

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Ages Eligible for Study: | 16 Years and older (Child, Adult, Senior) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01838889
United Kingdom | |
Primary Care; Mother and Baby Clinics | |
Borough of Blackburn with Darwen; Burnley; Preston; Manchester, Lancashire, Greater Manchester, United Kingdom |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Lancashire Care NHS Foundation Trust |
ClinicalTrials.gov Identifier: | NCT01838889 History of Changes |
Other Study ID Numbers: |
47847 PB-PG-1208-18087 ( Other Grant/Funding Number: NIHR Research for Patient Benefit ) |
First Posted: | April 24, 2013 Key Record Dates |
Last Update Posted: | December 8, 2014 |
Last Verified: | December 2014 |
Keywords provided by Lancashire Care NHS Foundation Trust:
Culturally adapted Group psychological intervention British South Asian women CBT |
Additional relevant MeSH terms:
Depression Depressive Disorder Depression, Postpartum Behavioral Symptoms |
Mood Disorders Mental Disorders Puerperal Disorders Pregnancy Complications |