A study testing the effects of a stress-resilience training programme on the well-being of graduate-entry medical students

ISRCTN ISRCTN16324994
DOI https://doi.org/10.1186/ISRCTN16324994
Secondary identifying numbers 2020-0044
Submission date
13/07/2025
Registration date
17/07/2025
Last edited
15/07/2025
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
Medical students often experience high levels of stress, anxiety, and burnout due to the demanding nature of their training. This study aims to explore whether a short, mindfulness-based programme called Enhanced Stress-Resilience Training (ESRT) can help graduate-entry medical students manage stress more effectively, build resilience, and feel better equipped to cope with the pressures of medical school.

Who can participate?
The study is open to students enrolled on the Graduate Entry Medicine (GEM) programme at Swansea University Medical School. Students are typically aged 21 years or over and come from a range of educational and professional backgrounds.

What does the study involve?
Participants are randomly assigned to one of two groups. One group takes part in the ESRT programme, which involves five weekly one-hour online sessions focusing on mindfulness, emotion regulation, and stress management. The other group takes part in weekly discussion sessions on health-related topics in medical education. All participants complete online questionnaires at three timepoints (before the programme, after 5 weeks, and again 6 months later). Some students are also invited to share their experiences in online interviews, written feedback, or focus groups.

What are the possible benefits and risks of participating?
Participants may benefit from learning practical tools to manage stress and improve their well-being. Risks are minimal but may include temporary discomfort when reflecting on challenging emotions or experiences. Support is available if needed, and all participants continue to have access to standard university wellbeing services.

Where is the study run from?
Swansea University Medical School (UK)

When is the study starting and how long is it expected to run for?
July 2020 to July 2023

Who is funding the study?
BMA Foundation for Medical Research (UK)

Who is the main contact?
Prof. Andrew Kemp, a.h.kemp@swansea.ac.uk

Contact information

Prof Andrew Kemp
Public, Scientific, Principal Investigator

School of Psychology
Faculty of Medicine, Health and Life Science
Singleton Park
Sketty
Swansea
SA2 8PP
United Kingdom

ORCiD logoORCID ID 0000-0003-1146-3791
Phone +44 (0)1792 604561
Email a.h.kemp@swansea.ac.uk

Study information

Study designRandomized controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)University/medical school/dental school, Other
Study typePrevention, Quality of life
Participant information sheet Not available in web format, please use contact details to request a participant information sheet.
Scientific titleEnhanced stress-resilience training (ESRT) for graduate-entry medical students: a randomised-controlled, mixed-method investigation
Study acronymESRT4GEM
Study objectivesTo assess the effectiveness, sustainability, and acceptability of Enhanced Stress-Resilience Training (ESRT) in improving psychological wellbeing outcomes among graduate-entry medical students, and to identify key barriers and facilitators to engagement.
Ethics approval(s)

Approved 21/09/2020, Swansea University Medical School Research Ethics Committee (Faculty of Medicine, Health and Life Science, Swansea University, Singleton Park, Swansea, SA2 8PP, United Kingdom; +44 (0)1792 602697; FMHLS-Ethics@swansea.ac.uk), ref: 2020-0044

Health condition(s) or problem(s) studiedPsychological stress, burnout, and anxiety among medical students, with a focus on prevention and early intervention to enhance resilience, emotion regulation, and psychological flexibility
InterventionThis randomised controlled trial allocates graduate-entry medical students to either Enhanced Stress-Resilience Training (ESRT) or an active control group. Participants attend five weekly 60-minute sessions delivered remotely via videoconferencing.

The ESRT group receives a structured mindfulness-based intervention adapted for time-pressured learners, delivered by a certified practitioner. Sessions include practices in breath awareness, interoception, meta-cognition, and emotional regulation.

The control group engages in weekly facilitated discussions on lay-press articles related to challenges in medical education, such as burnout, empathy, and clinical uncertainty.

Randomisation is computer-generated. All participants continue to receive standard pastoral support.
Intervention typeBehavioural
Primary outcome measurePsychological flexibility measured using the Acceptance and Action Questionnaire 2 (AAQ2) at baseline (T1), post-intervention (T2), and 6-month follow-up (T3)
Secondary outcome measures1. Resilience measured using the 10-item version of the Connor-Davidson Resilience Scale (CD-RISC 10) at baseline (T1), post-intervention (T2), and 6-month follow-up (T3)
2. Stress reactivity measured using the Perceived Stress Reactivity Scale (PSRS) at baseline (T1), post-intervention (T2), and 6-month follow-up (T3)
3. Acceptability, feasibility, and participant experience of ESRT assessed using qualitative data from online exit evaluations, one-on-one semi-structured interviews, and end-of-study focus groups following the 6-month follow-up (T3), analysed using reflexive thematic analysis
Overall study start date24/07/2020
Completion date27/07/2023

Eligibility

Participant type(s)Learner/student
Age groupAdult
Lower age limit18 Years
Upper age limit65 Years
SexBoth
Target number of participants167
Total final enrolment98
Key inclusion criteria1. Students on the graduate entry medical (GEM) programme at Swansea University Medical School (SUMS)
2. Because students have to have a first degree before enrolling on this programme the youngest they could be is 21 years old. Most students on the GEM programme are in the early to mid twenties age range be there is a small minority of more mature students who may be any age, rarely older than mid to late forties.
Key exclusion criteria1. Individuals not enrolled on the graduate entry medical (GEM) programme at Swansea University Medical School
2. Students who were unable to commit to the intervention schedule or declined to participate
Date of first enrolment05/04/2021
Date of final enrolment16/11/2022

Locations

Countries of recruitment

  • United Kingdom
  • Wales

Study participating centre

Swansea University
Singleton Park
Swansea
SA2 8PP
United Kingdom

Sponsor information

Swansea University
University/education

Faculty of Medicine, Human and Life Science
Singleton Park
Sketty
Swansea
SA2 8PP
Wales
United Kingdom

Phone +44 (0)1792 513400
Email FMHLS-Ethics@swansea.ac.uk
Website https://www.swansea.ac.uk
ROR logo "ROR" https://ror.org/053fq8t95

Funders

Funder type

Charity

BMA Foundation for Medical Research
Private sector organisation / Trusts, charities, foundations (both public and private)
Alternative name(s)
BMA Foundation
Location
United Kingdom

Results and Publications

Intention to publish date01/08/2025
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryStored in publicly available repository
Publication and dissemination planPlanned publication in a peer-reviewed journal
IPD sharing planThe datasets generated and analysed during the current study will be stored in a publicly available repository. Data accessible here: https://osf.io/f58ar/?view_only=0bc1365c4ab64a6c90e2182427f28c0e

Editorial Notes

14/07/2025: Study's existence confirmed by the Swansea University Medical School Research Ethics Committee.