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Completed

NCT Number: NCT01838889

Exploratory Trial 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.

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Key information

Conditions

Depression, Postpartum Depressive Disorder Female Urogenital Diseases and Pregnancy Complications Mental Disorders Mood Disorders Postnatal Depression in British South Asian Women Pregnancy Complications Puerperal Disorders Urogenital Diseases

Age range

16 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Primary Care; Mother and Baby Clinics

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: PHP

Primary outcomes

  1. 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 outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. 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)

  6. 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)

  7. 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 outcomes

  1. Revised Clinical Interview Schedule (CIS-R)

    Time frame: Assessment done at baseline

    Tool used to confirm the diagnosis of depression.

Sponsors and collaborators

Lead sponsor

Lancashire Care NHS Foundation Trust

Network

Collaborators

  • University of Manchester

Registry information

Official study title

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

Acronym: ROSHNI-D

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Apr 24, 2013
Registry last updated
Dec 8, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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