An evaluation of a cognitive-behavioural intervention for medical students
| ISRCTN | ISRCTN12744098 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12744098 |
| Protocol serial number | TMPSF2024001 |
| Sponsor | University of Manchester |
| Funder | The MPS Foundation |
- Submission date
- 09/06/2025
- Registration date
- 11/06/2025
- Last edited
- 20/04/2026
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
Medical students experience high rates of burnout and mental health distress, with approximately half reporting burnout, one-third experiencing depression, and one-tenth having suicidal thoughts. These issues are exacerbated during clinical placements and contribute to workforce attrition after qualification. Existing interventions are largely generic and show limited effectiveness. Thumos, a cognitive-behavioural therapy (CBT)-based intervention specifically tailored for healthcare professionals and students, addresses the stressful situations intrinsic to medical training and practice. This study will evaluate whether Thumos improves psychological resilience, confidence, burnout, and depression in medical students compared with services as usual (SAU).
Who can participate?
UK medical students in years involving clinical placements (e.g., Y4/Y5) nationally, aged 18 years and over.
What does the study involve?
Participants will be asked to complete a consent form and some baseline questionnaires. Random allocation will occur 1:1 to either the intervention or the control group. The intervention group will be asked to participate in a CBT intervention of two online group workshops and one individual video/phone call. The control group will continue with SAU. A follow-up questionnaire will be sent to all participants at post-intervention, 4 and 9 months. As part of the process evaluation, all participants will be asked to complete an evaluation questionnaire, and a subset of intervention participants will be invited to attend a qualitative interview.
What are the possible benefits and risks of participating?
Potential benefits for intervention arm participants include improved psychological wellbeing through engaging with the CBT intervention: Thumos. Risks are minimal, but for all participants, may include some emotional distress when responding to the questionnaires or discussing personal experiences in the interviews. For intervention arm participants, it is possible that the intervention may not be effective for everyone.
Where is the study run from?
Hull York Medical School, UK. The study will be run remotely using an online video platform.
When is the study starting and how long is it expected to run for?
December 2024 to March 2027
Who is funding the study?
The MPS Foundation, UK
Who is the main contact?
Dr Judith Johnson, University of Manchester, judith.johnson@manchester.ac.uk
Contact information
Public, Scientific, Principal investigator
University of Manchester
Jean McFarlane Building
176 Oxford Road
Manchester
M13 9PY
United Kingdom
 ORCID ID |
0000-0003-0431-013X |
|---|---|
| Phone | +44 (0)161 306 7811 |
| judith.johnson@manchester.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomized controlled parallel groups intervention trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | ACTIVATE: A randomised Controlled evaluation of Thumos: a cognitive-behavioural InterVention for medicAl sTudEnts |
| Study acronym | ACTIVATE |
| Study objectives | Medical students receiving Thumos, a cognitive behavioural intervention, will have improved psychological resilience at 4 month follow up in comparison to medical students receiving services as usual. |
| Ethics approval(s) |
Approved 20/12/2024, University of Manchester Research Ethics Committee 1 (2nd Floor, Christie Building, The University of Manchester, Oxford Road, Manchester, M139PL, United Kingdom; +44 (0)161 306 6000; urec1@manchester.ac.uk), ref: 2024-21589-38791 |
| Health condition(s) or problem(s) studied | Improvement of psychological resilience in UK medical students |
| Intervention | UK medical students in clinical placement years will be randomised 1:1 to receive either Thumos (a CBT intervention of two online group workshops and one individual video/phone call) or Services As Usual (SAU). Assessments will occur at baseline, post-intervention, 4-month, and 9-month follow-up. A mixed-methods process evaluation will assess acceptability and implementation with CBT therapists and medical educators from participating medical schools. Both control and intervention arm students will be invited to complete process questionnaires; only intervention arm medical students will be invited to take part in qualitative interviews. The study will invite UK medical educators from medical schools with participating students within the intervention arm to qualitative interviews as part of the process evaluation. It will also invite the cognitive behavioural therapists/clinical psychologists delivering the intervention to participate in qualitative interviews as part of the process evaluation. Added 11/06/2025: Participants will be randomised using simple 1:1 allocation via the Sealed Envelope platform, which generates the allocation sequence and maintains allocation concealment to ensure investigators remain blinded to treatment assignment. With 220 participants undergoing individual-level randomisation, simple randomisation is expected to achieve adequate balance between treatment arms without the need for blocking or stratification. Any post-randomisation covariate imbalances will be addressed through standard statistical adjustment methods during analysis. |
| Intervention type | Behavioural |
| Primary outcome measure(s) |
Psychological resilience will be measured using the 6-item Brief Resilience Scale (BRS) at baseline, post-intervention, 4- and 9-month follow-up. The primary endpoint is psychological resilience at the 4-month follow-up. |
| Key secondary outcome measure(s) |
The following secondary outcome measures are assessed at baseline, post-intervention, 4- and 9-month follow-up: |
| Completion date | 31/03/2027 |
Eligibility
| Participant type(s) | Health professional, Learner/student |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 100 Years |
| Sex | All |
| Target sample size at registration | 220 |
| Key inclusion criteria | UK medical students in years involving clinical placements (e.g., Y4/Y5) nationally. We will recruit from these groups for the main trial until the recruitment target is reached |
| Key exclusion criteria | Not meeting the participant inclusion criteria |
| Date of first enrolment | 16/06/2025 |
| Date of final enrolment | 30/04/2026 |
Locations
Countries of recruitment
- United Kingdom
- England
- Northern Ireland
- Scotland
- Wales
Study participating centres
Siwards Way
Heslington
Hull
YO10 5DD
England
Birmingham
B4 7ET
England
London
E1 2AD
England
Brighton
BN1 9PX
England
Uxbridge
UB8 3PH
England
Cardiff
CF10 3AT
Wales
London
EC1V 0HB
England
Ormskirk
L39 4QP
England
London
SW7 2AZ
England
Canterbury
CT2 7FS
England
University Road
Keele University
Staffordshire
ST5 5BG
England
London
WC2R 2LS
England
Lancaster
LA1 4YE
England
Leicester
LE1 7HA
England
Brayford Pool
Lincoln
LN6 7TS
England
Newcastle upon Tyne
NE1 7RU
England
Earlham Road
Norwich
NR4 7TJ
England
Mile End Road
London
E1 4NS
England
Belfast
BT7 1NN
Northern Ireland
Dundee
DD1 4HN
Scotland
Swansea
SA2 8QA
England
Coleraine
BT52 1SA
Northern Ireland
London
WC1E 6BT
England
Aberdeen
AB24 3FX
Scotland
Birmingham
B15 2TT
England
Tyndall Avenue
Bristol
BS8 1TH
England
Hunter Street
Buckingham
MK18 1EG
England
Trinity Lane
Cambridge
CB2 1TN
England
Preston
PR1 2HE
England
Chester
CH1 4BJ
England
Dundee
DD1 4HN
Scotland
South Bridge
Edinburgh
EH8 9YL
Scotland
Exeter
EX4 4PY
England
Glasgow
G12 8QQ
Scotland
Leeds
LS2 9JT
England
Leicester
LE1 7RH
England
Liverpool
L69 7ZX
England
Manchester
M13 9PL
England
Nottingham
NG7 2RD
England
Oxford
OX1 2JD
England
Portsmouth
PO1 2UP
England
Sheffield
S10 2TN
England
Southampton
SO17 1BJ
England
North Street
St. Andrews
KY16 9AJ
Scotland
Sunderland
SR1 3SD
England
Guildford
GU2 7XH
England
Gibbet Hill Road
Coventry
CV4 7AL
England
Worcester
WR2 6AJ
England
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan | The datasets generated during and/or analyzed during the current study will be stored in a publicly available repository: University of Manchester research repository - (https://figshare.manchester.ac.uk/) |
Editorial Notes
20/04/2026: The study participating centres were updated.
10/03/2026: The date of final enrolment was changed from 31/03/2026 to 30/04/2026.
12/06/2025: The date of first enrolment was changed from 09/06/2025 to 16/06/2025.
09/06/2025: Study's existence confirmed by the University of Manchester University Research Ethics Committee 1.
