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Learn more about In Review
Study protocol
M D Saju
Rajagiri College of Social Sciences
Corresponding Author
ORCiD: https://orcid.org/0000-0002-6188-9267
License:
This work is licensed under a CC BY 4.0 License. Read Full License
Background
The lockdown associated with the COVID-19 pandemic is likely to impact the mental health of people, especially those who are from economically backward and vulnerable sections of society. Mental health can be affected from various reasons including fear of disease transmission, from response measures like social distancing and lockdown, fear of being in quarantine, loneliness, depression due to isolation, fear of losing work and livelihood and avoiding health care due to fear of being infected. Telephonic befriending intervention by non-specialists will be used to provide social and emotional support to the youth from the Deen Dayal Upadhyaya Grameen Kaushalya Yojana (DDUGKY), an initiative of Government of India. This study aims to promote mental wellbeing and reduce depressive symptoms by assisting participants to mobilize social support from family, friends and significant others by using the telephonic befriending intervention.
Methods
In this article, we report the design and protocol of a multi-centre cluster randomised controlled trial. In total, 1440 participants aged 18-35 years, who have recently passed out of the DDU-GKY initiative will be recruited in the study, from 12 project implementing agencies across 6 geographical zones of India. Participants from 6 of these agencies will be assigned into the telephonic befriending intervention arm and the other 6 agency participants will be assigned to the general enquiry phone call arm (control). The primary outcomes of this study are mental wellbeing, depressive symptoms and perceived social support. Baseline assessments and follow-up assessments will be carried out 1 month following the intervention using WHO-5, PHQ and MSPSS-12 questionnaires. The befriending intervention will be provided by DDU-GKY staff who will be trained by a virtual training program.
Discussion
The results of this trial will help assess whether participants who are offered emotional, social and practical support through befriending, will experience lesser symptoms of depression and better mental health compared to participants who do not receive this intervention. And whether participants who receive the intervention will perceive better social support.
Trial registration
This intervention trial This intervention trial is registered under Clinical Trial Registry India (ICMR-NIMS) on 27th July 2020; registration number: CTRICTRI/2020/07/026834
Keywords
Randomised control trial, COVID-19, befriending, India
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CURRENT STATUS: Under Review
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Posted 25 Mar, 2021
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Invitations sent on 04 Apr, 2021
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This preprint is under consideration at Trials. A preprint is a preliminary version of a manuscript that has not completed peer review at a journal. Research Square does not conduct peer review prior to posting preprints. The posting of a preprint on this server should not be interpreted as an endorsement of its validity or suitability for dissemination as established information or for guiding clinical practice.
Learn more about In Review
Study protocol
M D Saju
Rajagiri College of Social Sciences
Corresponding Author
ORCiD: https://orcid.org/0000-0002-6188-9267
Badges
Prescreen
This manuscript passed our Prescreen assessment
Complete author information
Appropriate declaration statements
Potential risks to human health
Prescreen
Peer Review Timeline
CURRENT STATUS: Under Review
Version 1
Posted 25 Mar, 2021
No community comments so far
Reviewers invited
Invitations sent on 04 Apr, 2021
Reviewer #1 agreed
On 04 Apr, 2021
Editor assigned
On 19 Mar, 2021
Submission checks complete
On 19 Mar, 2021
First submitted
On 09 Aug, 2020
License:
This work is licensed under a CC BY 4.0 License. Read Full License
Background
The lockdown associated with the COVID-19 pandemic is likely to impact the mental health of people, especially those who are from economically backward and vulnerable sections of society. Mental health can be affected from various reasons including fear of disease transmission, from response measures like social distancing and lockdown, fear of being in quarantine, loneliness, depression due to isolation, fear of losing work and livelihood and avoiding health care due to fear of being infected. Telephonic befriending intervention by non-specialists will be used to provide social and emotional support to the youth from the Deen Dayal Upadhyaya Grameen Kaushalya Yojana (DDUGKY), an initiative of Government of India. This study aims to promote mental wellbeing and reduce depressive symptoms by assisting participants to mobilize social support from family, friends and significant others by using the telephonic befriending intervention.
Methods
In this article, we report the design and protocol of a multi-centre cluster randomised controlled trial. In total, 1440 participants aged 18-35 years, who have recently passed out of the DDU-GKY initiative will be recruited in the study, from 12 project implementing agencies across 6 geographical zones of India. Participants from 6 of these agencies will be assigned into the telephonic befriending intervention arm and the other 6 agency participants will be assigned to the general enquiry phone call arm (control). The primary outcomes of this study are mental wellbeing, depressive symptoms and perceived social support. Baseline assessments and follow-up assessments will be carried out 1 month following the intervention using WHO-5, PHQ and MSPSS-12 questionnaires. The befriending intervention will be provided by DDU-GKY staff who will be trained by a virtual training program.
Discussion
The results of this trial will help assess whether participants who are offered emotional, social and practical support through befriending, will experience lesser symptoms of depression and better mental health compared to participants who do not receive this intervention. And whether participants who receive the intervention will perceive better social support.
Trial registration
This intervention trial This intervention trial is registered under Clinical Trial Registry India (ICMR-NIMS) on 27th July 2020; registration number: CTRICTRI/2020/07/026834
Figure 1
Figure 2
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