Trial Review

Technical difficulties have been reported by some users of the search function and is being investigated by technical staff. Thank you for your patience and apologies for any inconvenience caused.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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 information initially 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] 305443 0
Nil
Universal Trial Number (UTN)
Trial acronym
NU-COVID
Linked study record

Health condition
Health condition(s) or problem(s) studied:
mental distress 323817 0
social exclusion 323818 0
Condition category
Condition code
Mental Health 321317 321317 0 0
Other mental health disorders
Mental Health 321318 321318 0 0
Anxiety
Mental Health 325498 325498 0 0
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] 321831 0
Prevention
Intervention code [2] 325041 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 329112 0
Any change in mental health measured using Patient Health Questionnaire 9 (PHQ9)
Timepoint [1] 329112 0
Baseline and 15 weeks post-intervention commencement
Primary outcome [2] 333347 0
Any change in mental health measured using General Health Questionnaire 12 (GHQ12)
Timepoint [2] 333347 0
Baseline and 15 weeks post-intervention commencement
Secondary outcome [1] 401504 0
Any change in social participation measured with Participation scale (P- scale)
Timepoint [1] 401504 0
Baseline and 15 weeks post-intervention commencement
Secondary outcome [2] 417006 0
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] 417006 0
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?
No
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] 24154 0
India
State/province [1] 24154 0

Funding & Sponsors
Funding source category [1] 309801 0
Hospital
Name [1] 309801 0
Herbertpur Christian Hosptial
Country [1] 309801 0
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] 314435 0
Individual
Name [1] 314435 0
Pooja S Pillai
Address [1] 314435 0
Herbertpur Christian Hospital, Emmanuel Hospital Association, Athan Bagh, Herbertpur, Uttarakhand 248142
Country [1] 314435 0
India

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309548 0
Institutional Ethics Committee Emmanuel Hospital Association
Ethics committee address [1] 309548 0
808/92, Deepali Building, Nehru Place, New Delhi, Delhi 110019, India
Ethics committee country [1] 309548 0
India
Date submitted for ethics approval [1] 309548 0
15/07/2020
Approval date [1] 309548 0
04/08/2020
Ethics approval number [1] 309548 0
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 114546 0
Mrs Pooja Pillai
Address 114546 0
Herbertpur Christian Hospital
Atten Bagh Rd, PO, Herbertpur, Uttarakhand 248142, India
Country 114546 0
India
Phone 114546 0
+1 7300836960
Fax 114546 0
Email 114546 0
poojas.burans@gmail.com
Contact person for public queries
Name 114547 0
Mrs Pooja Pillai
Address 114547 0
Herbertpur Christian Hospital
Atten Bagh Rd, PO, Herbertpur, Uttarakhand 248142, India
Country 114547 0
India
Phone 114547 0
+1 7300836960
Fax 114547 0
Email 114547 0
poojas.burans@gmail.com
Contact person for scientific queries
Name 114548 0
Dr Kaaren Mathias
Address 114548 0
University of Canterbury
20 Kirkwood Avenue, Upper Riccarton, Christchurch 8041
NZ
Country 114548 0
New Zealand
Phone 114548 0
+64 2041497530
Fax 114548 0
Email 114548 0
kaarenmathias@gmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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?




Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseDoes the Nae Umeed group intervention improve mental health and social participation? A pre-post study in Uttarakhand, India.2023https://dx.doi.org/10.1017/gmh.2023.38
N.B. These documents automatically identified may not have been verified by the study sponsor.