Completed

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

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What is being tested

Culturally adapted psychological intervention (Positive Health Programme)

Behavioral
Who is being recruted

Urogenital Diseases+5

+ Mental Disorders

+ Depressive Disorder

Over 16 Years
+8 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: March 2011
See protocol details

Summary

Principal SponsorLancashire Care NHS Foundation Trust
Last updated: December 8, 2014
Sourced from a government-validated database.Claim as a partner

Study start date: March 1, 2011

Actual date on which the first participant was enrolled.

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.

NCT01838889
Principal SponsorLancashire Care NHS Foundation Trust
Last updated: December 8, 2014
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

83 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

Over 16 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesMental DisordersDepressive DisorderFemale Urogenital Diseases and Pregnancy ComplicationsPregnancy ComplicationsPuerperal DisordersMood DisordersDepression, Postpartum

Criteria

4 inclusion criteria required to participate
living with their babies
over the age of 16 years
self-ascribed British women of South Asian origin as defined by UK Office of -National Statistics
who meet the criteria for ICD-10 depression
4 exclusion criteria prevent from participating
actively suicidal
post-partum or other psychosis
severely depressed
women with diagnosed physical or learning disability

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Depressed Mothers randomized to experimental arm will undergo a 12 week group psychological intervention on the 'positive health programme'.

Group II

No Intervention
Depressed mothers randomized to TAU arm will receive treatment as usual.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Primary Care; Mother and Baby Clinics

Borough of Blackburn With Darwen; Burnley; Preston; Manchester, United KingdomOpen Primary Care; Mother and Baby Clinics in Google Maps
CompletedOne Study Center