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Exploratory Trial of a Group Psychological Intervention for Postnatal Depression in British Mother's of South Asian Origin (ROSHNI-D)
This study has been completed.
Sponsor:
Lancashire Care NHS Foundation Trust
Collaborator:
University of Manchester
Information provided by (Responsible Party):
Lancashire Care NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT01838889
First received: April 14, 2013
Last updated: December 5, 2014
Last verified: December 2014
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Purpose
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.
| Condition | Intervention |
|---|---|
| Depression, Postpartum Postnatal Depression in British South Asian Women | Behavioral: Culturally adapted psychological intervention (Positive Health Programme) |
| Study Type: | Interventional |
| Study Design: | 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 |
Resource links provided by NLM:
Further study details as provided by Lancashire Care NHS Foundation Trust:
Primary Outcome Measures:
- 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 Outcome Measures:
- 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) ]
Other Outcome Measures:
- Revised Clinical Interview Schedule (CIS-R) [ Time Frame: Assessment done at baseline ]Tool used to confirm the diagnosis of depression.
| Enrollment: | 83 |
| Study Start Date: | March 2011 |
| Study Completion Date: | October 2013 |
| Primary Completion Date: | August 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
|
No Intervention: Treatment as usual (TAU)
Depressed mothers randomized to TAU arm will receive treatment as usual.
|
Eligibility| Ages Eligible for Study: | 16 Years and older (Child, Adult, Senior) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01838889
Please refer to this study by its ClinicalTrials.gov identifier: NCT01838889
Locations
| United Kingdom | |
| Primary Care; Mother and Baby Clinics | |
| Borough of Blackburn with Darwen; Burnley; Preston; Manchester, Lancashire, Greater Manchester, United Kingdom | |
Sponsors and Collaborators
Lancashire Care NHS Foundation Trust
University of Manchester
More Information
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 ) |
| Study First Received: | April 14, 2013 |
| Last Updated: | December 5, 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 |
ClinicalTrials.gov processed this record on September 21, 2017