An evaluation of a cognitive-behavioural intervention for medical students
| ISRCTN | ISRCTN12744098 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12744098 |
| Secondary identifying numbers | TMPSF2024001 |
- Submission date
- 09/06/2025
- Registration date
- 11/06/2025
- Last edited
- 12/06/2025
- Recruitment status
- 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
| Study design | Randomized controlled parallel groups intervention trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | University/medical school/dental school |
| Study type | Efficacy |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet. |
| 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 | 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. |
| Secondary outcome measures | The following secondary outcome measures are assessed at baseline, post-intervention, 4- and 9-month follow-up: 1. Confidence in coping with adverse events measured using the Confidence in Coping with Adverse Events (CCAE) questionnaire 2. Burnout measured using the Oldenburg Burnout Inventory (OLBI) 3. Depression measured using the Patient-Health Questionnaire-9 (PHQ-9) 4. Areas of Quality of Life will be measured using the Recovery of Quality of Life-Utility Index (ReQoL-UI) 5. Self-reported sickness absence measured using two question items. The first question asks about total days lost within the past 4 weeks; the second question asks how many working or studying days specifically were lost within this timeframe. 6. Support access will be measured using four question items. Four question items will be used to assess whether participants are accessing any form of psychological wellbeing service, which type of support they are accessing, when they began accessing this, and when they anticipate they will stop accessing this |
| Overall study start date | 01/12/2024 |
| Completion date | 31/03/2027 |
Eligibility
| Participant type(s) | Health professional, Learner/student |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 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 | 31/03/2026 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Siwards Way
Heslington
Hull
YO10 5DD
United Kingdom
Sponsor information
University/education
Jean McFarlane Building
176 Oxford Road
Manchester
M13 9PY
England
United Kingdom
| Phone | +44 (0)161 275 5436 |
|---|---|
| FBMHethics@manchester.ac.uk | |
| Website | https://www.manchester.ac.uk/ |
"ROR" |
https://ror.org/027m9bs27 |
Funders
Funder type
Research organisation
No information available
Results and Publications
| Intention to publish date | 31/03/2028 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in publicly available repository, Available on request |
| Publication and dissemination plan | The trial protocol will shortly be submitted for publication. Planned main publication in high-impact peer-reviewed journal with paper analysing the primary outcomes of the effectiveness of Thumos in increasing psychological resilience compared to SAU at 4-month follow-up. This paper will also report on the secondary outcomes of the effectiveness of Thumos compared to SAU at post-intervention, 4- and 9-month follow-ups in the endpoints of confidence, burnout, depression, mental health and self-reported sickness absence. |
| 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
12/06/2025: The recruitment start date 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.
