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

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

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.

Study Overview

• Status: Completed
• Conditions: Depression, Postpartum; Postnatal Depression in British South Asian Women
• Intervention / Treatment: Behavioral: Culturally adapted psychological intervention (Positive Health Programme)

• Study Type: Interventional
• Enrollment (Actual): 83
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Lancashire, Greater Manchester
    • Borough of Blackburn with Darwen; Burnley; Preston; Manchester, Lancashire, Greater Manchester, United Kingdom
      • Primary Care; Mother and Baby Clinics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: PHP
No Intervention: Treatment as usual (TAU); Depressed mothers randomized to TAU arm will receive treatment as usual.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Edinburgh Post Natal Depression Scale (EPDS; Cox et al 1987)	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

Outcome Measure	Time Frame
EuroQoL-5 Dimensions (EQ-5D)	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)	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)	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)	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)	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)	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)	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

Outcome Measure	Measure Description	Time Frame
Revised Clinical Interview Schedule (CIS-R)	Tool used to confirm the diagnosis of depression.	Assessment done at baseline

Collaborators and Investigators

• Sponsor: Lancashire Care NHS Foundation Trust
• Collaborators: University of Manchester

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: March 1, 2011
• Primary Completion (Actual): August 1, 2013
• Study Completion (Actual): October 1, 2013

Study Registration Dates

• First Submitted: April 14, 2013
• First Submitted That Met QC Criteria: April 19, 2013
• First Posted (Estimate): April 24, 2013

Study Record Updates

• Last Update Posted (Estimate): December 8, 2014
• Last Update Submitted That Met QC Criteria: December 5, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Keywords: CBT; Culturally adapted; Group psychological intervention; British South Asian women
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Pregnancy Complications; Puerperal Disorders; Depression; Depressive Disorder; Depression, Postpartum
• Other Study ID Numbers: 47847; PB-PG-1208-18087 (Other Grant/Funding Number: NIHR Research for Patient Benefit)