Assessing the impact of transcendental meditation on the mental health and well-being of UK ambulance service personnel: A single-arm study

ISRCTN ISRCTN53474391
DOI https://doi.org/10.1186/ISRCTN53474391
Secondary identifying numbers UK Ambulance 2021-2023
Submission date
31/01/2024
Registration date
15/02/2024
Last edited
15/02/2024
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Background and study aims
The COVID-19 pandemic has significantly impacted the mental health of ambulance service workers, exacerbating existing stressors and leading to increased rates of depression, anxiety, and PTSD among healthcare professionals. Even before the pandemic, the UK's ambulance service faced challenges such as high sickness absence rates and burnout among staff, highlighting the need for effective interventions. Despite existing stress coping methods provided by ambulance service trusts, stress levels among ambulance staff post-pandemic continue to rise, emphasising the necessity for additional solutions.

Transcendental Meditation (TM) has emerged as a promising intervention, showing efficacy in reducing stress and improving psychological well-being across diverse populations. This study aims to assess the effectiveness of TM specifically for ambulance service workers in the UK, recognising the urgent need for interventions to support their well-being amidst ongoing challenges. Through the assessment of PTSD symptoms, perceived stress, and other mental health indicators, this research seeks to offer valuable insights into TM's potential as a practical and effective tool to address a critical gap in current support strategies for ambulance service personnel.

Who can participate?
Individuals working in various roles in the Ambulance Service were eligible to participate in the study.

What does the study involve?
Participants received instruction in Transcendental Meditation (TM) and were recommended to practice the technique twice daily, for 20 minutes each session, in the morning and evening. The TM course included a 60-minute introductory presentation, followed by 4 consecutive days of instruction lasting 90-120 minutes per session, which could be attended either in person for all sessions or as blended learning, with the first session one-to-one in person and subsequent sessions held in small groups remotely. Remote sessions utilised a specially designed app for course materials, with participants connecting to their TM instructor via video conference for daily meditation sessions. Both in-person and remote courses provided identical content. Additionally, participants were offered individual and group follow-up sessions, available both in person and online. Participants signed a consent form and completed a baseline survey before learning TM, followed by surveys post-TM instruction at 3 weeks and 3 months. Standard self-reporting measures were used to assess post-traumatic stress disorder (PTSD) symptoms, perceived stress, anxiety, depression, insomnia, professional fulfilment including burnout and general mental health and wellbeing,

What are the possible benefits and risks of participating?
Participating in the study and learning TM offered potential benefits to reduce stress and related conditions, enhancing general health and wellbeing, and fostering daily resilience. No anticipated risks were associated with learning TM, and participants were given the option to withdraw from the practice and study at any time.

Where is the study run from?
TM instruction took place in the East of England area. The TM instruction was arranged by the David Lynch Foundation UK and the study was conducted in collaboration with the Center for Social-Emotional Health & Consciousness, Maharishi International University, USA.

When is the study starting and how long is it expected to run for?
June 2021 to March 2023. The study commenced recruitment in July 2021 and concluded in March 2023.

Who is funding the study?
Funding was provided by the David Lynch Foundation UK, with a grant from the Postcode Places Trust.

Who is the main contact?
The main contact was Deirdre Parsons the Principal Investigator, dparsons@davidlynchfoundation.org.uk

Contact information

Ms Deirdre Parsons
Public, Scientific, Principal Investigator

David Lynch Foundation UK
9 Garden Square
Rendlesham
Suffolk
IP12 2GW
United Kingdom

Phone +44 (0)7711311616
Email dparsons@davidlynchfoundation.org.uk

Study information

Study designSingle-arm multi-centre interventional study
Primary study designInterventional
Secondary study designNon randomised study
Study setting(s)Charity/Voluntary sector
Study typePrevention, Quality of life, Treatment, Efficacy
Participant information sheet https://form.jotform.com/211894520663357
Scientific titleEvaluating the impact of transcendental meditation (TM) on reducing PTSD Symptoms and stress-related conditions among ambulance staff: A three-month intervention study
Study objectivesThe hypothesis is that individuals employed in the ambulance service who regularly practise transcendental meditation (TM) for three months will show improvements in reducing stress levels and related conditions.
Ethics approval(s)

Approved 02/07/2021, Maharishi International University (Maharishi University of Management Research Institute) (1000 N 4th Street, Fairfield, Iowa, 52557, United States of America; +1 3196140357; ftravis@miu.edu), ref: DLFUK2021

Health condition(s) or problem(s) studiedReduction in post-traumatic stress disorder (PTSD) symptoms and stress-related conditions in ambulance staff.
InterventionThis is a single-arm, multi-centre interventional study involving 60 participants from the UK ambulance service, conducted in collaboration with the David Lynch Foundation UK and the Center for Social-Emotional Health, Maharishi International University (MIU) in the USA, where participants voluntarily learned transcendental meditation (TM) and practised it twice daily for three months.

The participants, employed in various roles within the ambulance service, will learn TM and be instructed to practice it twice daily. Standard self-reporting measures will be administered online at baseline, post-TM course, three weeks, and three months. Additionally, semi-structured one-to-one interviews will be conducted via a video call with 11 participants after the three months following TM instruction. Participants receive instruction from a specialised TM instructor in small groups in four sessions over consecutive days, with options for in-person or blended learning, where the initial session is conducted in person, followed by subsequent sessions conducted remotely online using a video conference platform.
Intervention typeBehavioural
Primary outcome measurePost-traumatic stress disorder (PTSD) symptoms measured using a self-reporting PTSD Checklist (PCL-5) at baseline, 3 weeks and 3 months
Secondary outcome measuresThe following secondary outcome measures are assessed at baseline, 3 weeks and 3 months:
1. Perceived stress using the self-reporting Perceived Stress Scale (PPS-10)
2. Depression using the self-reporting Patient Health Questionnaire (PHQ-9)
3. Anxiety using the self-reporting General Anxiety Disorder 7 scale (GAD-7)
4. The severity, and impact of insomnia using the self-reporting Insomnia Severity Index (ISI-7)
5. Mental well-being covering subjective well-being and psychological functioning using the self-reporting Warwick-Edinburgh Mental Wellbeing Scales (WEMWBS)
6. Professional Fulfilment using the self-reporting Professional Fulfilment Index (PFI-16)
7. Burnout using the self-reporting Professional Fulfilment Index i(PFI-16)
Overall study start date01/06/2021
Completion date27/03/2023

Eligibility

Participant type(s)Healthy volunteer, Health professional
Age groupMixed
Lower age limit18 Years
Upper age limit70 Years
SexBoth
Target number of participants60
Total final enrolment60
Key inclusion criteria1. Working within the UK ambulance service
2. Adults aged over 18 years
Key exclusion criteria1. Self-reported or diagnosed unstable psychotic symptoms
2. Any prior involvement in TM instruction
3 Signed off or retired from the ambulance service
Date of first enrolment05/07/2021
Date of final enrolment10/10/2022

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centres

Missenden Abbey Adult Education College
School Grounds
Great Missenden
HP16 0BD
United Kingdom
Premier Inn
Prince of Wales Road
Norwich
NR1 1DX
United Kingdom
Writtle College
Lordship Road, Writtle
Chelmsford
CM1 3RR
United Kingdom
Regus
8 Duncannon street
London
WC2N 4JF
United Kingdom

Sponsor information

David Lynch Foundation UK
Charity

9 Garden Square
Rendlesham
Suffolk
IP12 2GW
England
United Kingdom

Phone None provided
Email dparsons@davidlynchfoundation.org.uk
Website https://www.davidlynchfoundation.org.uk

Funders

Funder type

Charity

Postcode Places Trust

No information available

David Lynch Foundation UK

No information available

Results and Publications

Intention to publish date01/05/2024
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planPlanned publication in a high-impact peer-reviewed journal
IPD sharing planThe data sets generated during and/or analyse during the current study will be available upon request from Deirdre Parsons, Principal Investigator: dparsons@davidlynchfoundation.org.uk beginning at 9 months and ending 36 months following article publication

Documents available: Study Protocol, Informed consent form
Data will be available individual participant data meta-analysis for Investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose..
Data will be available from Investigator’s proposals that have been submitted up to 36 months following article publication.

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol file 15/02/2024 No No

Additional files

44976 Protocol.pdf

Editorial Notes

05/02/2024: Study's existence confirmed by the Institution Review Board of Maharishi International University.