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

NCT01838889 | Completed

• 2 other identifiers: 47847PB-PG-1208-18087
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression, Postpartum; Postnatal Depression in British South Asian Women

Keywords

Culturally adapted; Group psychological intervention; British South Asian women; CBT

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• 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)

Other Outcomes (1)

• Revised Clinical Interview Schedule (CIS-R)

  Assessment done at baseline

Study Arms (2)

Culturally adapted psychological intervention (PHP)

EXPERIMENTAL

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)

Treatment as usual (TAU)

NO INTERVENTION

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

Interventions

Culturally adapted psychological intervention (Positive Health Programme) BEHAVIORAL

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.

Also known as: PHP

Culturally adapted psychological intervention (PHP)

Eligibility Criteria

• Age: 16 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• women with diagnosed physical or learning disability,
• post-partum or other psychosis,
• severely depressed
• actively suicidal.

Sponsors & Collaborators

• Lancashire Care NHS Foundation Trust: lead
• University of Manchester: collaborator

Study Sites (1)

Primary Care; Mother and Baby Clinics

Borough of Blackburn With Darwen; Burnley; Preston; Manchester, Lancashire, Greater Manchester, United Kingdom

Location

Related Publications (2)

• Husain N, Lunat F, Lovell K, Sharma D, Zaidi N, Bokhari A, Syed A, Tomenson B, Islam A, Chaudhry N, Waheed W. Exploratory RCT of a group psychological intervention for postnatal depression in British mothers of South Asian origin - ROSHNI-D. Acta Psychol (Amst). 2023 Aug;238:103974. doi: 10.1016/j.actpsy.2023.103974. Epub 2023 Jul 4.

  PMID: 37413896 DERIVED

• 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.

  PMID: 26603604 DERIVED

MeSH Terms

Conditions

Depression, Postpartum

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2013
• First Posted: April 24, 2013
• Study Start: March 1, 2011
• Primary Completion: August 1, 2013
• Study Completion: October 1, 2013
• Last Updated: December 8, 2014

Record last verified: 2014-12

Locations

GB (1)