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

Primary Purpose

Depression, Postpartum, Postnatal Depression in British South Asian Women

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Culturally adapted psychological intervention (Positive Health Programme)
Sponsored by
Lancashire Care NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression, Postpartum focused on measuring Culturally adapted, Group psychological intervention, British South Asian women, CBT

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Primary Care; Mother and Baby Clinics

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Culturally adapted psychological intervention (PHP)

Treatment as usual (TAU)

Arm Description

Depressed Mothers randomized to experimental arm will undergo a 12 week group psychological intervention on the 'positive health programme'.

Depressed mothers randomized to TAU arm will receive treatment as usual.

Outcomes

Primary Outcome Measures

Edinburgh Post Natal Depression Scale (EPDS; Cox et al 1987)

Secondary Outcome Measures

EuroQoL-5 Dimensions (EQ-5D)
The Parenting Stress Index (PSI)
Multidimensional Scale of Perceived Social Support (MSPSS)
Dyadic Adjustment Scale (DAS)
Home Inventory (HI)
Hamilton Rating Scale for Depression (HRSD)
Client Service Receipt Inventory (CSRI)

Full Information

First Posted
April 14, 2013
Last Updated
December 5, 2014
Sponsor
Lancashire Care NHS Foundation Trust
Collaborators
University of Manchester
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1. Study Identification

Unique Protocol Identification Number
NCT01838889
Brief Title
Exploratory Trial of a Group Psychological Intervention for Postnatal Depression in British Mother's of South Asian Origin
Acronym
ROSHNI-D
Official Title
Exploratory RCT of a Group Psychological Intervention for Postnatal Depression in British Mother's of South Asian Origin
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
October 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lancashire Care NHS Foundation Trust
Collaborators
University of Manchester

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Postpartum, Postnatal Depression in British South Asian Women
Keywords
Culturally adapted, Group psychological intervention, British South Asian women, CBT

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
83 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Culturally adapted psychological intervention (PHP)
Arm Type
Experimental
Arm Description
Depressed Mothers randomized to experimental arm will undergo a 12 week group psychological intervention on the 'positive health programme'.
Arm Title
Treatment as usual (TAU)
Arm Type
No Intervention
Arm Description
Depressed mothers randomized to TAU arm will receive treatment as usual.
Intervention Type
Behavioral
Intervention Name(s)
Culturally adapted psychological intervention (Positive Health Programme)
Other Intervention Name(s)
PHP
Intervention Description
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.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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)
Title
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)
Title
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)
Title
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)
Title
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)
Title
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)
Title
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 Pre-specified Outcome Measures:
Title
Revised Clinical Interview Schedule (CIS-R)
Description
Tool used to confirm the diagnosis of depression.
Time Frame
Assessment done at baseline

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Primary Care; Mother and Baby Clinics
City
Borough of Blackburn with Darwen; Burnley; Preston; Manchester
State/Province
Lancashire, Greater Manchester
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
26603604
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.
Results Reference
derived

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

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