Home » Trials » SLCTR/2024/024
Efficacy of a group mindfulness intervention in improving psychological wellbeing among a stratified random sample of individuals, who have been serving the Sri Lanka army during the civil war.
-
SLCTR Registration Number
SLCTR/2024/024
Date of Registration
The date of last modification
Nov 11, 2024
Scientific Title of Trial
Efficacy of a group mindfulness intervention in improving psychological wellbeing among a stratified random sample of individuals, who have been serving the Sri Lanka army during the civil war.
Public Title of Trial
Randomized control trial to investigate the efficacy of a virtual mindfulness intervention versus standard care in improving psychological wellbeing among individuals from the Sri Lanka armed forces.
Disease or Health Condition(s) Studied
Mindfulness
Scientific Acronym
None
Public Acronym
None
Brief title
None
Universal Trial Number
U1111-1309-8575
Any other number(s) assigned to the trial and issuing authority
2/20 - Ethics Review Committee, Faculty of Medical Sciences, University of Sri Jayawardanepura
What is the research question being addressed?
How effective is a group mindfulness intervention in creating a change in the level of psychological well–being in participants from Sri Lanka army who are in active service?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Masking not used
Control
Standard therapy/practice
Assignment
Parallel
Purpose
Supportive care
Study Phase
Not Applicable
Intervention(s) planned
The participants have been selected from different camps and regiments of Sri Lanka army. As the intervention is delivered virtually, there will be no physical study setting. The participants are expected to participate from wherever they are; this can be while they are in their respective camps or home when they are on vacation.
A survey has been conducted among a sample of individuals from the Sri Lanka army to obtain an idea of their mental health needs. The expected total sample size for the survey was 500. The researchers obtained the number of officers and non-officers (other rankers) from Sri Lanka army and calculated the representative number of officers and other rankers that should be allocated for each regiment in proportionate to their total percentage in the Sri Lanka army. Out of these 500 participants, a proportional allocation from each stratum will be used from the sample. Every Nth participant will be selected until the sample size (63) is reached. Further calculation will be done for the proportion of officers and other rankers from each stratum
The principal investigator will do the recruitment with the assistance of the Sri Lanka army head quarters.
A virtual mindfulness protocol has been developed with reference to the mobile application, “Mindfulness Coach”, which has been developed by the Veterans Affairs (VA) Department of the USA. This has been extensively researched for its suitability to be used in military samples. Prior to the development of the protocol, the PI has participated in two online training programs. One was on Mindfulness while the other was on mindfulness-based cognitive therapy (MBCT). In addition to this, FGD’s were conducted with Buddhist scholars to decide on the possibility of incorporating further techniques of Buddhist mindfulness.
The protocol was developed in Sinhala and is expected to be recorded on the Zoom online platform. The principal investigator, who is a licensed clinical psychologist, is expected to carry out the recording of the sessions using her voice.
Where required, pictures and sounds that are similar to the ones that have been used in the mobile application will be used in the recordings.
The protocol has 08 sections that guides a variety of mindfulness practices. They are : 1. Seated practice. 2. Awareness of the body. 3. Awareness of the breath. 4. Awareness of senses. 5. Loving-kindness meditation. 6. Mindful eating. 7. Mindful walking. 8. Mindfulness of emotional discomfort. Additional sections are to be used at user discretion. 1. Mindful listening. 2. Mindful looking. 3. Mindfulness of emotional discomfort – Part 02. In addition to these sections, a practice log is expected to be introduced, which provides a graphical representation of their practice in the form of a chart. This is expected to help them track their progress in daily practice.
The protocol is expected to be pre- tested on a sample from the Sri Lanka army, before its use. The intervention will be delivered by the principal investigator. The study group will not be provided with the option of recording the Zoom sessions. Further , they are expected to agree not to share details of the intervention with the controls until the study period is over.
Inclusion criteria
Exclusion criteria
Primary outcome(s)
|
1.
PERMA profiler |
[ Before the intervention Immediately after the intervention ] |
|
2.
International Trauma Questioannire ( ITQ) |
[ Before the intervention Immediately after the intervention ] |
|
3.
General Health Questionnaire ( GHQ) - 12 |
[] |
|
4.
Mindful Attention Awareness Scale (MAAS) |
[] |
Secondary outcome(s)
|
1.
Subjective ratings of well being - Participants will be asked if their level of wellbeing improved after practicing each mindfulness technique for one week. If they respond to it as Yes, they will be asked to rate their level of improvement out of a hundred. |
[ Before the intervention Immediately after the intervention ] |
Target number/sample size
63 for each arm
Countries of recruitment
Anticipated start date
2024-08-01
Anticipated end date
2024-09-30
Date of first enrollment
2024-10-01
Date of study completion
Recruitment status
Recruiting
Funding source
None
Regulatory approvals
None
Status
Approved
Date of Approval
2021-02-25
Approval number
02/20
Details of Ethics Review Committee
| Name: | Ethicc Review Committee , Faculty of Medical Sciences |
| Institutional Address: | Faculty of Medical Sciences , University of Sri Jayawardenepura , Nugegoda |
| Telephone: | 0112758588 |
| Email: | erc.fms@sjp.ac.lk |
Contact person for Scientific Queries/Principal Investigator
Tina Solomons
Senior Lecturer
Deartment of Clinical Sciences , Faculty of Medicine , General Sir John Kotelawala Defence University ( KDU)
0771720867
thsolomons@gmail.com
Contact Person for Public Queries
Tina Solomons
Senior Lecturer
Deartment of Clinical Sciences , Faculty of Medicine , General Sir John Kotelawala Defence University ( KDU)
0771720867
thsolomons@gmail.com
Primary study sponsor/organization
Faculty of Medical Sciences, University of Sri Jayawardenepura
Faculty of Medical Sciences,
University of Sri Jayewardenepura,
Gangodawila, Nugegoda,
Sri Lanka
94 11 2881788
fms@sjp.ac.lk
https://medical.sjp.ac.lk/
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
Yes
IPD sharing plan description
What data will be shared- Individual participant data that underlie the results being reported, after de-identification (text, tables, figures and appendices) What other documents will be available - Study protocol, statistical analysis When will the data be available - Beginning 3 months and ending 5 years following article publication With who will the data be shared- Investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose For what types of analyses will the data shared - For individual participant data meta-analysi By what mechanism will the data be available - Proposals should be directed to thsolomons@gmail.com. To gain access, data requestors will need to sign a data access agreement. Data will be available for 5 years rom the time of publication at ((provide link to proposed IPD database)
Study protocol available
Yes
Protocol version and date
Not available
Protocol URL
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
