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CompletedNCT01838889ROSHNI-DUpdated Dec 8, 2014

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

An interventional study of Culturally adapted psychological intervention (Positive Health Programme) in Depression, Postpartum and Postnatal Depression in British South Asian Women, sponsored by Lancashire Care NHS Foundation Trust. Completed at 1 site in United Kingdom. Open to female participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2014-12-08.

Sponsored by Lancashire Care NHS Foundation Trust · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
83
Allocation
Randomized
Ages
16 Years and older
Sex
Female
01

Study 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.

02

Conditions studied

  • Depression, Postpartum
  • Postnatal Depression in British South Asian Women

Keywords

  • Culturally adapted
  • Group psychological intervention
  • British South Asian women
  • CBT
03

Who can participate

Ages eligible
16 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

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

Exclusion Criteria:

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

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
83 participants (actual)

Study arms

  • 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)

  • No intervention
    Treatment as usual (TAU)

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

Interventions

  • BehavioralCulturally 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.

    Also known as: PHP

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What researchers measure

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)

    Tool used to confirm the diagnosis of depression.

    Time frame: Assessment done at baseline

06

Study locations

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

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. PubMed 26603604 ↗
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Registry details

Key details

Study ID
NCT01838889
Lead sponsor
Lancashire Care NHS Foundation Trust
Collaborators
University of Manchester
Responsible party
Sponsor
First posted
Apr 24, 2013
Start date
Mar 2011
Primary completion
Aug 2013
Completion
Oct 2013
Last update
Dec 8, 2014

Oversight

Data monitoring committee
No
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