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

30 Sep 2021

The date of last modification

Oct 07, 2021



Application Summary


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


Trial Details


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

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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

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-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).

]
3.
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4.
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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).

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Post-intervention (T1)

]
3.
[]
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



State of Ethics Review Approval


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 & Sponsor Information


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

Secondary study sponsor (If any)

None





Trial Completion details


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