Condition category
Mental and Behavioural Disorders
Date applied
23/01/2017
Date assigned
26/01/2017
Last edited
26/01/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Postnatal depression (PND) is a type of depression that some mothers experience after having a baby. It can cause disability and suffering in women, negative consequences for their infants and their family with huge costs to society. Rates of PND in British South Asian (BSA) women are higher than the general population. Due to language and cultural barriers, BSA women often do not access appropriate health care services. This has been highlighted as a major contributor to unequal healthcare across the UK populations. Mothers of South-Asian backgrounds (Bangladesh, Pakistan and India) account for a large number of births in the UK. There is a growing concern about ethnic inequalities in the provision and access to postnatal depression services, which is an identified priority in both England and Scotland. The Positive Health Programme (PHP) is a new culturally adapted treatment program that has been developed to help women with PND. Smaller studies have shown that it may lead to improved mood, and successfully engages and supports women from a South Asian background. The aim of this study is to look at the effectiveness and cost-effectiveness of PHP in the treatment of BSA women with PND.

Who can participate?
British women of South Asian origin with PND who have had a baby within the last year.

What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group receive the PHP programme as well as standard treatment. This involves 12 group sessions which last for 60-90 minutes every week for two months and then fortnightly for a further two months. The sessions involve learning life skills and having the opportunity to meet other women in similar circumstances. Those in the second group receive usual care only. At the start of the study and then after four and 12 months, participants in both groups complete a questionnaire to measure their depression levels. At the end of the study, the costs of delivering the programme are also calculated from questionnaires completed by participants at the start of the study and after four and 12 months.

What are the possible benefits and risks of participating?
Participants who receive the programme may benefit from improvements to their mood. There are no major risks involved with participants, although some women may find taking about experiences and feelings to be difficult.

Where is the study run from?
Lancashire Care Foundation NHS Trust (UK)

When is the study starting and how long is it expected to run for?
July 2016 to June 2020

Who is funding the study?
National Institute for Health Research (UK)

Who is the main contact?
1. Dr Saadia Aseem (public)
saadia.aseem@manchester.ac.uk
2. Professor Nusrat Husain (scientific)
nusrat.husain@manchester.ac.uk

Trial website

lancashirecare.nhs.uk/Roshni2

Contact information

Type

Public

Primary contact

Dr Saadia Aseem

ORCID ID

Contact details

University of Manchester
Oxford Road
Manchester
M13 9PL
United Kingdom
+44 161 306 6000
saadia.aseem@manchester.ac.uk

Type

Scientific

Additional contact

Prof Nusrat Husain

ORCID ID

Contact details

University of Manchester & Lancashire Care NHS Foundation Trust
3rd Floor
Jean Mcfarlane Building University of Manchester
Oxford Road
Manchester
M13 9PL
United Kingdom
+44 161 306 7921
nusrat.husain@manchester.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

32313

Study information

Scientific title

Multi Centre RCT of a group psychOlogical intervention for poStnatal depression in britisH mothers of south asiaN origIn - ROSHNI-2

Acronym

ROSHNI-2

Study hypothesis

The aim of this study is to investigate the clinical and cost-effectiveness of a culturally adapted group psychological intervention called the Positive Health Programme (PHP) in British South Asian (BSA) women with post-natal depression.

Ethics approval

North West - Greater Manchester South Research Ethics Committee, 26/10/2016, ref: 16/NW/0727

Study design

Randomised; Interventional; Design type: Treatment, Screening, Diagnosis, Psychological & Behavioural

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Specialty: Primary Care, Primary sub-specialty: Mental Health; UKCRC code/ Disease: Mental Health/ Mood [affective] disorders, Reproductive Health and Childbirth/ Other maternal disorders predominantly related to pregnancy

Intervention

Consenting, eligible women will be randomized via an independent remote randomisation service based at the King's College Clinical trials unit (CTU). After each block of 18 women have been recruited into the trial in each centre, women will be block randomised to the two treatments to give 9 intervention and 9 control participants.

Intervention: Participants receive a CBT-based culturally adapted group psychological intervention called the Positive Health Programme (PHP) added to the Treatment As Usual. The manual assisted intervention PHP has been designed to be delivered by non-specialist mental health professionals. The 12 groups/sessions are educational life skills classes, based on a CBT model. Each PHP session will last for 60-90 minutes and will be delivered weekly for two months, and then fortnightly for further two months.

Treatment as usual (TAU): Participants undergo study assessments along with routine assessment and management as usually conducted by the participating general practices.

The assessments for both the arms will be at baseline, at 4 months (end of intervention) and then 12 months after baseline. The duration of the assessment will not be more than 45-60 minutes.

Intervention type

Other

Phase

Phase III

Drug names

Primary outcome measures

Recovery from postnatal depression is measured using the Hamilton Depression Rating Scale (HDRS) at 4 months (end of intervention)

Secondary outcome measures

1. Treatment response is measured using the Hamilton Depression Rating Scale (HDRS) at baseline, 4 and 12 months
2. Cost data will be collected using an Economic Patient Questionnaire at baseline, 4 and 12 months

Overall trial start date

01/07/2016

Overall trial end date

30/06/2020

Reason abandoned

Eligibility

Participant inclusion criteria

1. Self-ascribed British women of South Asian origin as defined by Office of National Statistics (ONS, 2011)
2. Over the age of 16 years and living with their infants up to the age of 12 months (1-Year)
3. Meet the criteria for DSM-V depression

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

Planned Sample Size: 720; UK Sample Size: 720

Participant exclusion criteria

1. Women with diagnosed learning disability that will impact on capacity to consent
2. Post-partum psychosis
3. Any other diagnosed psychosis
4. Actively suicidal (previous history of self-harm or suicide attempt).

Recruitment start date

01/11/2016

Recruitment end date

30/08/2018

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Lancashire Care Foundation NHS Trust
De Mount Whalley Road
Accrington
BB5 5AD
United Kingdom

Sponsor information

Organisation

Lancashire Care NHS Foundation Trust

Sponsor details

Sceptre Point
Sceptre Way
Bamber Bridge
Preston
PR5 6AW
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Study Protocol will be published before the end of 2017 and there is further planned publication in high-impact peer reviewed journals at the end of the recruitment and final results in year 2021.

IPD Sharing plan:
The datasets generated and/or analysed during the current study will be included in the subsequent results publication.

Intention to publish date

31/12/2021

Participant level data

Other

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes