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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Exploratory RCT of a Group Psychological Intervention for Postnatal Depression in British Mother's of South Asian Origin

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.

Detailed Summary:
Sponsor: Lancashire Care NHS Foundation Trust

Current Primary Outcome: 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). ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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) ]


Original Secondary Outcome: Same as current

Information By: Lancashire Care NHS Foundation Trust

Dates:
Date Received: April 14, 2013
Date Started: March 2011
Date Completion:
Last Updated: December 5, 2014
Last Verified: December 2014