Home » Trials » SLCTR/2021/027
A randomized controlled trial of a mindfulness-based online intervention to reduce stress and improve well-being among healthcare workers at a tertiary care hospital during the COVID-19 pandemic
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SLCTR Registration Number
SLCTR/2021/027
Date of Registration
The date of last modification
Oct 02, 2023
Scientific Title of Trial
A randomized controlled trial of a mindfulness-based online intervention to reduce stress and improve well-being among healthcare workers at a tertiary care hospital during the COVID-19 pandemic
Public Title of Trial
A randomized controlled trial of a mindfulness-based online intervention to reduce stress and improve well-being among healthcare workers during the COVID-19 pandemic
Disease or Health Condition(s) Studied
Stress
Scientific Acronym
None
Public Acronym
None
Brief title
Mindfulness to reduce stress and improve wellbeing among healthcare workers
Universal Trial Number
U1111-1269-3265
Any other number(s) assigned to the trial and issuing authority
None
What is the research question being addressed?
Is an online mindfulness programme effective to reduce stress and improve wellbeing among healthcare workers during the COVID19 pandemic?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Masking not used
Control
Standard therapy/practice
Assignment
Other
Purpose
Supportive care
Study Phase
Not Applicable
Intervention(s) planned
Study setting: Colombo North Teaching Hospital (CNTH), but the study will be conducted completely online, using Zoom sessions. All wards, clinics, and labs at CNTH will be potential sites of recruitment to the study.
a) Method of randomization- simple randomization b) Unit of randomization- individual participants c) Method of sequence - Computer-generated random number sequence d) Allocation and randomization will be done by two individuals at separate sites.
This intervention will consist of 6 online mindfulness sessions conducted at weekly intervals, and daily homework. The duration of each weekly session will be 1 hour. The duration of daily home practice will be 20 minutes. The online programme will be structured mostly according to the Mindfulness based stress reduction (MBSR) program developed by Jon Kabat Zinn. During the programme, participants will learn to use formal meditation skills (body scan, mindful movement, sitting meditation, three minute breathing space) and informal mindfulness techniques (incorporating mindfulness into daily activities, such as mindful eating) through audios, videos and assignments. At the final session (week-6) the participants will be encouraged to continue the practices which were learnt during the programme and to join a follow-up 1-hour session 3 months later to reflect on their progress and to refresh their practice. The intervention will be administered by a postgraduate trainee in psychiatry, under the guidance of consultant psychiatrists who are part of the research team.
Control- A waitlist control group No specific intervention will be provided during this period. However, if any participants in the waitlist control arm request urgent psychological intervention, a referral to the mental health services in the hospital will be provided. This study assesses stress and wellbeing as outcomes, and the control group will also be provided with the intervention once the waitlist period is over.
Blinding will not be used.
Inclusion criteria
1) Aged 18 or above- Both males and females will be included. 2) Currently employed as a healthcare worker at Colombo North Teaching Hospital-All categories of healthcare workers - doctors, nurses, ancillary staff (pharmacists, medical laboratory technologists, radiographers, etc.), and supporting staff – will be included. 3) Able to access the internet at home 4) Able to commit to 1 hour per week for a Zoom meeting 5) Able to participate in the programme spanning 6 weeks.
Exclusion criteria
1) Cannot read and understand Sinhala or find it difficult to follow the Zoom sessions conducted in Sinhala 2) Receive another form of psychotherapy concurrently 3) Started on medication for a psychiatric condition within the last 3 months 4) (if taking psychiatric treatment for a long time) had any changes to their usual medication within the last 3 months
Primary outcome(s)
1.
1) Stress level assessed using Perceived Stress Scale |
[ -Baseline (T0) -Post-intervention (T1) i.e. immediately after completion of the 6 week programme -3-month Follow-up (T2). ] |
2.
2) Wellbeing assessed using WHO-5 Wellbeing index |
[ Baseline (T0) -Post-intervention (T1) i.e. immediately after completion of the 6 week programme -3-month Follow-up (T2). ] |
Secondary outcome(s)
1.
Acceptability using Acceptability of Interventions Measure (Weiner et al., 2017). |
[ Post-intervention (T1) ] |
2.
Feasibility of Intervention Measure (Weiner et al., 2017). |
[ Post-intervention (T1) ] |
3.
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4.
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Target number/sample size
90 - 45 in each arm
Countries of recruitment
Sri Lanka
Anticipated start date
2021-10-01
Anticipated end date
2022-03-31
Date of first enrollment
Date of study completion
Recruitment status
Pending
Funding source
Self
Regulatory approvals
Not applicable
Status
Approved
Date of Approval
2021-08-31
Approval number
P/80/08/2021
Details of Ethics Review Committee
Name: | Ethics Review Committee, Faculty of Medicine, University of Kelaniya, |
Institutional Address: | Ethics Review Committee, Faculty of Medicine, University of Kelaniya, |
Telephone: | +94 -112961267/ +94 -112961000 |
Email: | erckelaniya@gmail.com |
Contact person for Scientific Queries/Principal Investigator
Anuradha Baminiwatta
Lecturer (Probationary)
Department of Psychiatry, Faculty of Medicine, University of Kelaniya
0112961115
+94777959197
baminiwatta@kln.ac.lk
Contact Person for Public Queries
Aruni Hapangama
Senior Lecturer
Department of Psychiatry, Faculty of Medicine, University of Kelaniya
0112961115
0711417627
ahapangama@kln.ac.lk
Primary study sponsor/organization
Dr. Anuradha Baminiwatta
Lecturer
Department of Psychiatry, Faculty of Medicine, University of Kelaniya
+94777959197
baminiwatta@kln.ac.lk
https://medicine.kln.ac.lk/index.php/dr-a-k-a-b-baminiwatta
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
Yes
IPD sharing plan description
All individual participant data will be made available after de-identification. No other specific document will be shared directly. Data will be made available immediately following publication, on a data repository (e.g. Mendeley data).
Study protocol available
No
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results