Mental HealthNCT06874699
Evaluation of the Exercise for Wellbeing Pathway at York St John University
A study testing Physical activity programme in people with Mental Health, run by York St John University at 1 site in United Kingdom.
Trial summary
In autumn 2024, York St John University launched a physical activity programme for university students facing mental health challenges. The purpose of this project is to conduct a mixed-methods evaluative study of this new service over a 6-month period. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mental Health
- What is being tested?
- Physical activity programme
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 27 Feb 2025to 10 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Student enrolled at York St John University
- Age 18 years and over
- Undertaking a course which requires attendance at York St John University's Lord Mayor's Walk Campus
- Presenting to the student wellbeing team with mild-to-moderate mental health concerns (defined as experiencing symptoms of poor mental health such as feeling depressed or socially isolated, prolonged stress and anxiety, or experiencing academic decline that makes their daily life more difficult but maintain daily functioning) and expressing an interest in enhancing their mental health and daily functioning
Who cannot join
- Unwilling or unable to provide written informed consent
- Unable to attend (or to participate in) the scheduled physical activity sessions
- Unsuccessful physical activity clearance using the physical activity readiness questionnaire (PAR-Q+)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
York St John University
York, North Yorkshire, YO31 7EX
About this study
Official title: On-campus Supervised Physical Activity Programme for University Students Facing Mental Health Challenges: a Feasibility Study Exploring Feasibility, Acceptability, Fidelity and Preliminary Effects
In autumn 2024, York St John University launched a physical activity programme for university students facing mental health challenges. The purpose of this project is to conduct a mixed-methods evaluative study of this new service over a 6-month period. It is anticipated that 20-40 students will be recruited to the study, which will assess the following: assess the following: feasibility, the extent to which the service can be delivered successfully; acceptability, the extent to which the service is considered appropriate, satisfactory, or attractive by programme recipients and intervention delivery staff; fidelity, the extent to which the key service components (e.g., assessment procedures, physical activity programme) were implemented as planned and adaptations were made; preliminary effects, with relation to physical, mental and social health outcomes.
- Conditions
- Mental Health
- Being tested
- Physical activity programme
- Keywords
- Exercise, Physical activity, Anxiety, Psychological distress, Depression, University student
- Medical subject headings
- Psychological Well-Being, Motor Activity, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical activity programmeBehavioural
The physical activity programme will have the following features:
- 6-week programme
- 1-2 supervised physical activity sessions per week
- 60 minutes per session, including a mixture of physical activities (e.g. walking, other aerobic physical activity, resistance, balance and stretching exercises)
- Self-selected physical activity intensity
- Group-based (maximum of 10 students per session)
- Sessions supervised by a qualified exercise instructor. A member of the University's Wellbeing team will also be present to offer students mental health support, if needed.
- Physical activity behavioral strategies incorporated into the 6-week programme (e.g., goal setting, action planning, exploring barriers and enablers, setting cues or prompts for self-directed PA)
- Encouragement to be physically active away from the supervised sessions
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | This group will comprise of university students who are enrolled on the Exercise for Wellbeing pathway and who have consented to participate in this evaluative study. Receives: Behavioral: Physical activity programme |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of recruitment
The average number of participants recruited per month
Measured: Over the course of the 6-month enrollment period
Rate of retention
The proportion of participants who complete the study
Measured: From enrollment to the end of intervention at 6 weeks
Rate of attendance
Median number of supervised physical activity sessions attended amongst all participants
Measured: From enrollment to the end of intervention at 6 weeks
Acceptability of the service
The extent to which the service is considered appropriate, satisfactory, or attractive by programme recipients and intervention delivery staff. Assessed primarily via one-to-one interviews and an exit survey.
Measured: At the 6-week follow-up assessment
Secondary outcomes (10)
Fidelity
The extent to which the key service components (e.g., assessment procedures, physical activity programme) were implemented as planned and adaptations were made. Assessed primarily via session record data and post-intervention interviews with participants and service delivery staff.
Measured: From enrollment to the end of intervention at 6 weeks
Mean time per day in moderate-to-vigorous physical activity
Assessed using an Axivity AX6 wrist-worn accelerometer worn continuously for 7 days at each study timepoint
Measured: Assessed at baseline and at the 6-week follow-up
10-item Recovering Quality of Life (ReQoL) questionnaire
The minimum index score for ReQoL-10 is 0 and the maximum is 40, where 0 indicates poorest quality of life and 40 indicates highest quality of life.
Measured: Assessed at baseline and at the 6-week follow-up
9-item Patient Health Questionnaire (PHQ-9)
The total score ranges from 0 to 27 with higher scores indicating more severe depression.
Measured: Assessed at baseline and at the 6-week follow-up
38-item Mental Health Inventory (MHI-38)
All the MHI items are scored on a six-point scale (1-6) except for items 9 and 28, which are scored on a five-point scale (1-5). The raw score range is 38-226, with higher scores on the Mental Health Index indicating less psychological distress and greater psychological well-being.
Measured: Assessed at baseline and at the 6-week follow-up
Resting blood pressure (automated)
Measured: Assessed before and after the 6-week intervention period
Estimated maximal oxygen uptake (YMCA submaximal cycle test)
Measured: Assessed before and after the 6-week intervention period
Grip strength (Jamar handgrip dynamometer)
Measured: Assessed before and after the 6-week intervention period
Lower-limb muscular strength/endurance (30-s sit-to-stand test)
Measured: Assessed before and after the 6-week intervention period
Adverse events
Measured: From enrollment to the end of the exit assessment after the end of the 6-week intervention period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2025
- Study start27 Feb 2025
- Primary completion10 Sep 2025
- Study completion10 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- York St John University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Professor Garry Tew, PhD, Principal investigator, York St John University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06874699
- Sponsor's protocol ID
- ETH2425-0237
- Status last verified
- Sep 2025
- First submitted
- 3 Mar 2025
- Last updated
- 17 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Anonymised IPD may be shared on the University's data repository, RaYDaR.
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- On-campus Supervised Physical Activity Programme for University Students Facing Mental Health Challenges: a Feasibility Study Exploring Feasibility, Acceptability, Fidelity and Preliminary Effects
- ClinicalTrials.gov ID
- NCT06874699
- Acronym / sponsor ID
- ETH2425-0237
- Conditions
- Mental Health
- Keywords
- Exercise, Physical activity, Anxiety, Psychological distress, Depression, University student
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- York St John UniversityUniversity, hospital or other
- Study start
- 27 Feb 2025 (actual)
- Primary completion
- 10 Sep 2025 (actual)
- Study completion
- 10 Sep 2025 (actual)
- First posted
- 13 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In autumn 2024, York St John University launched a physical activity programme for university students facing mental health challenges. The purpose of this project is to conduct a mixed-methods evaluative study of this new service over a 6-month period. It is anticipated that 20-40 students will be recruited to the study, which will assess the following: assess the following: feasibility, the extent to which the service can be delivered successfully; acceptability, the extent to which the service is considered appropriate, satisfactory, or attractive by programme recipients and intervention delivery staff; fidelity, the extent to which the key service components (e.g., assessment procedures, physical activity programme) were implemented as planned and adaptations were made; preliminary effects, with relation to physical, mental and social health outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Physical activity programmeThis group will comprise of university students who are enrolled on the Exercise for Wellbeing pathway and who have consented to participate in this evaluative study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Student enrolled at York St John University
- Age 18 years and over
- Undertaking a course which requires attendance at York St John University's Lord Mayor's Walk Campus
- Presenting to the student wellbeing team with mild-to-moderate mental health concerns (defined as experiencing symptoms of poor mental health such as feeling depressed or socially isolated, prolonged stress and anxiety, or experiencing academic decline that makes their daily life more difficult but maintain daily functioning) and expressing an interest in enhancing their mental health and daily functioning
Key exclusion criteria (3 listed)
- Unwilling or unable to provide written informed consent
- Unable to attend (or to participate in) the scheduled physical activity sessions
- Unsuccessful physical activity clearance using the physical activity readiness questionnaire (PAR-Q+)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical activity programmeThe physical activity programme will have the following features: * 6-week programme * 1-2 supervised physical activity sessions per week * 60 minutes per session, including a mixture of physical activities (e.g. walking, other aerobic physical activity, resistance, balance and stretching exercises) * Self-selected physical activity intensity * Group-based (maximum of 10 students per session) * Sessions supervised by a qualified exercise instructor. A member of the University's Wellbeing team will also be present to offer students mental health support, if needed. * Physical activity behavioral strategies incorporated into the 6-week programme (e.g., goal setting, action planning, exploring barriers and enablers, setting cues or prompts for self-directed PA) * Encouragement to be physically active away from the supervised sessions | Behavioural | Intervention group |
Primary outcome
Rate of recruitment
Time frame: Over the course of the 6-month enrollment period
The average number of participants recruited per month
Rate of retention
Time frame: From enrollment to the end of intervention at 6 weeks
The proportion of participants who complete the study
Rate of attendance
Time frame: From enrollment to the end of intervention at 6 weeks
Median number of supervised physical activity sessions attended amongst all participants
Acceptability of the service
Time frame: At the 6-week follow-up assessment
The extent to which the service is considered appropriate, satisfactory, or attractive by programme recipients and intervention delivery staff. Assessed primarily via one-to-one interviews and an exit survey.
10 secondary outcomes
Fidelity
Time frame: From enrollment to the end of intervention at 6 weeks
Mean time per day in moderate-to-vigorous physical activity
Time frame: Assessed at baseline and at the 6-week follow-up
10-item Recovering Quality of Life (ReQoL) questionnaire
Time frame: Assessed at baseline and at the 6-week follow-up
9-item Patient Health Questionnaire (PHQ-9)
Time frame: Assessed at baseline and at the 6-week follow-up
38-item Mental Health Inventory (MHI-38)
Time frame: Assessed at baseline and at the 6-week follow-up
Resting blood pressure (automated)
Time frame: Assessed before and after the 6-week intervention period
Estimated maximal oxygen uptake (YMCA submaximal cycle test)
Time frame: Assessed before and after the 6-week intervention period
Grip strength (Jamar handgrip dynamometer)
Time frame: Assessed before and after the 6-week intervention period
Lower-limb muscular strength/endurance (30-s sit-to-stand test)
Time frame: Assessed before and after the 6-week intervention period
Adverse events
Time frame: From enrollment to the end of the exit assessment after the end of the 6-week intervention period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2025.
- Webpage that describes the University's Exercise for Wellbeing pathwayLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. Anonymised IPD may be shared on the University's data repository, RaYDaR.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Professor Garry Tew, PhD principal investigator
York St John University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical activity programme in people with Mental Health, run by York St John University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of recruitment (time frame: Over the course of the 6-month enrollment period). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2025.