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Trial registered on ANZCTR

Registration number

ACTRN12623000047695

Ethics application status

Approved

Date submitted

5/12/2022

Date registered

16/01/2023

Date last updated

16/01/2023

Date data sharing statement initially provided

16/01/2023

Date results provided

16/01/2023

Type of registration

Retrospectively registered

Titles & IDs

Public title

Does participation in Nae Umeed (New Hope) group psychosocial intervention improve mental health for carers of people with disability during the acute COVID-19 pandemic in India? A pre-post uncontrolled study.

Scientific title

Does participation in Nae Umeed (New Hope) group psychosocial intervention improve mental health and social participation for carers of people with disability during the acute COVID-19 pandemic in India? A pre-post uncontrolled study.

Secondary ID [1]

Nil

Universal Trial Number (UTN)

Trial acronym

NU-COVID

Linked study record

Health condition

Health condition(s) or problem(s) studied:

mental distress

social exclusion

Condition category

Condition code

Mental Health

Other mental health disorders

Mental Health

Anxiety

Mental Health

Depression

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Nae Umeed is a 9-module intervention facilitated in groups by a community health worker which focus on skills and knowledge for self-care and caregiving, that is followed by 5 modules related to financial management and budgeting for the household, a critical skill deficit which is even more necessary give the economic impacts of the COVID-19 crisis. Participation in facilitated Curriculum titled Nae Umeed was over 14 sessions in the same group of carers - each session was face to face and lasted 1.5 hours. The sessions were conducted over 14-15 weeks (one module per week).
Session attendance and summary minutes was collected during every session.
We used a convenience sampling technique to invite participation from carers in communities in 3 locations in Dehradun district with whom we have existing relationships as we work with their family members in the Burans programme. There was a total of 21 groups with 5 -7 participants in each ie n=115.
The content of Nae Umeed includes;
Module One: What is a Caregiver?
Module Two: Mental Illness
Module Three: Caring for Someone with Mental Illness I - Communication Skill
Module Four: Caring for Someone with Mental Illness II – Interaction
Module Five: Medication
Module Six: Alcohol and Health
Module Seven: Managing Stress
Module Eight: Self-Care
Module Nine: Being an Effective Caregiver and Review
Module ten to fourteen - Budgeting and home finance management

The sessions were facilitated by community health workers who met with groups of caregivers within the communities of Dehradun, Uttarakhand. They were trained by Project officers and an online platform to deliver Nae Umeed with an interactive and participatory facilitation style. Activities during sessions included brief explanations delivered by the facilitator using visual aids from the manuals, whole group or small group discussions oriented around pre-defined discussion questions, role play activities, group team-building activities, and group revision quizzes.

Intervention code [1]

Prevention

Intervention code [2]

Treatment: Other

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Any change in mental health measured using Patient Health Questionnaire 9 (PHQ9)

Timepoint [1]

Baseline and 15 weeks post-intervention commencement

Primary outcome [2]

Any change in mental health measured using General Health Questionnaire 12 (GHQ12)

Timepoint [2]

Baseline and 15 weeks post-intervention commencement

Secondary outcome [1]

Any change in social participation measured with Participation scale (P- scale)

Timepoint [1]

Baseline and 15 weeks post-intervention commencement

Secondary outcome [2]

Feasibility, acceptability and relevance of the Nae Umeed intervention for carers duing the COVID-19 crisis using attendance and qualitative interviews. These components will be analysed together as a composite outcome to indicate the acceptability, feasibility and relevance of the study.

Timepoint [2]

15 weeks post-intervention commencement

Eligibility

Key inclusion criteria

Women or men resident in target slums of Dehradun and Selaqui (Sahaspur, Selaqui, Brahmanwala, Kanwali Road, Prem Nagar)
Aged 18 y and older
Carers of person with disability or psychosocial disability
Personally affected by psychosocial disability

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Women or men not residing in the area for the ensuing 15 weeks

Study design

Purpose of the study

Prevention

Allocation to intervention

Non-randomised trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Single group

Other design features

Pre Post uncontrolled study

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

Descriptive analysis and t test to determine significant change in mean scores

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

Actual

10/08/2020

Date of last participant enrolment

Anticipated

Actual

31/08/2020

Date of last data collection

Anticipated

Actual

28/02/2021

Sample size

Target

100

Accrual to date

Final

115

Recruitment outside Australia

Country [1]

India

State/province [1]

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Herbertpur Christian Hosptial

Address [1]

Atten Bagh Rd, PO, Herbertpur, Uttarakhand 248142, India

Country [1]

India

Primary sponsor type

Individual

Name

Kaaren Mathias

Address

University of Canterbury
20 Kirkwood Avenue, Upper Riccarton, Christchurch 8041
NZ

Country

New Zealand

Secondary sponsor category [1]

Individual

Name [1]

Pooja S Pillai

Address [1]

Herbertpur Christian Hospital, Emmanuel Hospital Association, Athan Bagh, Herbertpur, Uttarakhand 248142

Country [1]

India

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Institutional Ethics Committee Emmanuel Hospital Association

Ethics committee address [1]

808/92, Deepali Building, Nehru Place, New Delhi, Delhi 110019, India

Ethics committee country [1]

India

Date submitted for ethics approval [1]

15/07/2020

Approval date [1]

04/08/2020

Ethics approval number [1]

Protocol 240

Summary

Brief summary

Internationally 
The COVID-19 virus has been declared a global pandemic and is one of the most serious respiratory infections the world has seen since the 1918 influenza epidemic. 

Locally
In both rural and urban communities where we work with Emmanuel Hospital Association (EHA) teams in rural and urban Uttarakhand, we have identified high levels of anxiety and limited knowledge and skills on how to respond to both COVID-19 and the lockdown response. People with disabilities and mental illness are not able to access medicines and usual support services such as Disabled persons organisations and early learning centres are not available. Our interactions with caregivers in the preceding 3 months as well as research we conducted among people with disabilities and their acute mental health impacts which included interviews with their carers demonstrated they are experiencing increased anxiety and distress linked to concerns for themselves and their family members. Due to COVID-19 lockdown and stress there are also widespread reports of increased domestic violence as well as neglect of people with high needs
Research gap
A Lancet paper published on 16 April 2020 (doi:10.1016/S2215-0366(20)30168-1) outlines key priorities for mental health science research in response to COVID-19. They identify the following research as highest priority:
1.	Documenting the mental health effects of the COVID-19 pandemic, and the suppression control measures on the population, with a focus on vulnerable groups
2.	Develop, evaluate and refine mechanistically driven interventions to address the psychological, social, and neuro-scientific aspects of the pandemic.

Taking all this into account we are keen to increase skills and knowledge for mental health among carers during the COVID-19 crisis using a resource for carers that we have already developed

STUDY QUESTION
What is the effectiveness of the Nae Umeed intervention in increasing mental health and social participation for caregivers of people with disability and mental health problems during the COVID-19 crisis.

What is the feasibility, acceptability and relevance of the Nae Umeed intervention for carers duing the COVID-19 crisis.

We wanted to examine whether a 14 module intervention can improve social participation and mental health status among carers in urban and peri-urban Uttarakhand and to assess implementation issues and factors to guide the value and pragmatic issues necessary for scaling.

Trial website

Trial related presentations / publications

Public notes

This study was conducted during COVID-19 period in India.

Contacts

Principal investigator

Name

Mrs Pooja Pillai

Address

Herbertpur Christian Hospital
Atten Bagh Rd, PO, Herbertpur, Uttarakhand 248142, India

Country

India

Phone

+1 7300836960

Fax

poojas.burans@gmail.com

Contact person for public queries

Name

Pooja Pillai

Address

Herbertpur Christian Hospital
Atten Bagh Rd, PO, Herbertpur, Uttarakhand 248142, India

Country

India

Phone

+1 7300836960

Fax

poojas.burans@gmail.com

Contact person for scientific queries

Name

Kaaren Mathias

Address

University of Canterbury
20 Kirkwood Avenue, Upper Riccarton, Christchurch 8041
NZ

Country

New Zealand

Phone

+64 2041497530

Fax

kaarenmathias@gmail.com

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

Sensitive data pertaining to mental health status cannot be shared and needs to maintain confidentiality.

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
17786	Ethical approval				Ethics approval from Emmanuel Hospital Association... [More Details]	382872-(Uploaded-10-12-2022-07-42-28)-Study-related document.pdf
17787	Other				Nae Umeed manual (9 modules) out of the 14 modules... [More Details]	382872-(Uploaded-05-12-2022-09-51-52)-Study-related document.pdf

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Does the Nae Umeed group intervention improve mental health and social participation? A pre-post study in Uttarakhand, India.	2023	https://dx.doi.org/10.1017/gmh.2023.38

N.B. These documents automatically identified may not have been verified by the study sponsor.

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