Exploratory Trial of a Group Psychological Intervention for Postnatal Depression in British Mother's of South Asian Origin (ROSHNI-D)

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

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 Design

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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

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
No Intervention: Treatment as usual (TAU); Depressed mothers randomized to TAU arm will receive treatment as usual.

Outcome Measures

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Primary Outcome Measures :

1. 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 :

1. 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) ]
2. 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) ]
3. 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) ]
4. 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) ]
5. 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) ]
6. 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) ]
7. 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:

1. Revised Clinical Interview Schedule (CIS-R) [ Time Frame: Assessment done at baseline ]
   Tool used to confirm the diagnosis of depression.

Eligibility Criteria

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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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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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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
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