Trial record 3 of 99 for:    "Depression, Postpartum" [DISEASE]

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by Lancashire Care NHS Foundation Trust
Sponsor:
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: April 19, 2013
Last verified: April 2013
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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). ] [ Designated as safety issue: No ]

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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Revised Clinical Interview Schedule (CIS-R) [ Time Frame: Assessment done at baseline ] [ Designated as safety issue: No ]
    Tool used to confirm the diagnosis of depression.


Estimated Enrollment: 86
Study Start Date: March 2011
Estimated Study Completion Date: October 2013
Estimated 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
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01838889

Contacts
Contact: Nusrat Husain, MBBS, Dip Psyche +44 161 306 7928 nusrat.husain@manchester.ac.uk
Contact: Nasim Chaudhry, MBBS nasimchaudhry@btinternet.com

Locations
United Kingdom
Primary Care; Mother and Baby Clinics Recruiting
Borough of Blackburn with Darwen; Burnley; Preston; Manchester, Lancashire, Greater Manchester, United Kingdom
Principal Investigator: Nusrat Husain, MBBS, Dip Psyche, MCPS (Psych)         
Sponsors and Collaborators
Lancashire Care NHS Foundation Trust
University of Manchester
  More Information

No publications provided

Responsible Party: Lancashire Care NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT01838889     History of Changes
Other Study ID Numbers: 47847, PB-PG-1208-18087
Study First Received: April 14, 2013
Last Updated: April 19, 2013
Health Authority: United Kingdom: Research Ethics Committee
United Kingdom: National Institute for Health Research

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 July 26, 2014