Bounce Back: Enhancing resiliency in university students
| ISRCTN | ISRCTN18276230 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN18276230 |
| Secondary identifying numbers | MR/W00242/1/2 |
- Submission date
- 11/10/2022
- Registration date
- 27/10/2022
- Last edited
- 01/07/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Other
Plain English summary of protocol
Background and study aims
From a student's perspective, the university is to educate and help them develop their careers. University life also presents students with the opportunity for greater independence and to develop problem-solving skills they can use in everyday life. University life however also presents students with many challenges such as living within a budget, making relationships, and managing study demands. For some students, this can be challenging and affect their resiliency and therefore their ability to bounce back from daily challenges faced. Over time struggling to meet everyday challenges at university can increase the likelihood of students experiencing mental health difficulties.
Efforts made by universities to address the emotional well-being of students are largely targeted at treating mental health difficulties once they begin to impact their study and daily lives. However, continuing to invest in and expand student well-being services to meet demand and avoid long waiting times is becoming increasingly unrealistic. Another approach to addressing increased demand to treat mental health difficulties could be to enable students to become more resilient in the face of challenges they are faced with before such difficulties emerge.
An approach based on Cognitive Behavioural Therapy and delivered by a psychological practitioner has recently been developed to enhance resiliency. The intervention follows four steps, whereby the student is supported to identify their strengths to construct a Personal Model of Resilience and apply this to a challenge being faced. In doing so they will hopefully realise the strengths they have in other areas of their life and be able to apply these to enhance their resiliency and overcome challenges they are struggling with.
Who can participate?
Students aged 16 years or over who are a resident in the UK and are currently attending the University of Exeter will be able to undergo a screening assessment to determine if they will be eligible to take part in this trial.
What does the study involve?
The main aim of this study is to understand any problems that may arise when running a bigger study to examine if a written intervention helps enhance resiliency in a student population or not. If suitable for the study, students will be randomised to receive the 6 week intervention straight away or after a delay. Comparisons will be made between the two groups at different time points to see if the intervention looks like it has potential to improve resiliency. If it does and interviews indicate the intervention has good levels of acceptability, results will inform a much larger study to enable us to be more confident drawing conclusions.
What are the possible benefits and risks of participating
Working with students, this strength-based approach to enhancing resiliency has informed the development of a written self-help intervention. Being self-help offers greater flexibility for students to work through the intervention at a time and place of their choice. However, in the case of any student struggling with any feature of the self-help intervention, support can be requested from someone trained in the approach to help them overcome difficulties and continue to work through the intervention.
Where is the study run from?
The study is being run from the University of Exeter (UK)
When is the study starting and how long is it expected to run for?
September 2021 to March 2026
Who is funding the study?
The study is being funded by the UKRI – MRC Adolescence, Developing Mind and Mental Health Scheme (UK)
Who is the main contact?
Prof Paul Farrand, teamnurture-u@exeter.ac.uk
Contact information
Principal Investigator
Sir Henry Wellcome Building for Mood Disorders Research
Clinical Education Development and Research (CEDAR)
Psychology
University of Exeter
Exeter
EX4 4QG
United Kingdom
 ORCID ID |
0000-0001-7898-5362 |
|---|---|
| Phone | +44 1392 724793 |
| teamnurture-U@exeter.ac.uk |
Scientific
Sir Henry Wellcome Building for Mood Disorders Research
Clinical Education Development and Research (CEDAR)
Psychology
University of Exeter
Exeter
EX4 4QG
United Kingdom
| Phone | +44 1392 724793 |
|---|---|
| teamnurture-U@exeter.ac.uk |
Public
Sir Henry Wellcome Building for Mood Disorders Research
Clinical Education Development and Research (CEDAR)
Psychology
University of Exeter
Exeter
EX4 4QG
United Kingdom
| Phone | +44 1392 724793 |
|---|---|
| teamnurture-U@exeter.ac.uk |
Study information
| Study design | Interventional randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Internet/virtual, University/medical school/dental school |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet. |
| Scientific title | Developing and evaluating a stepped change whole-university approach for student wellbeing and mental health: feasibility study with embedded pilot RCT of a written strength-based low-intensity CBT Intervention to enhance resiliency |
| Study acronym | Bounce Back |
| Study objectives | This study aims to examine the effectiveness of a written strength-based intervention based on Cognitive Behavioural Therapy to enhance resiliency in young people that are currently well. |
| Ethics approval(s) |
Approved 22/09/2022, CLES Psychology Ethics Committee, University of Exeter (Queens Drive, Exeter, EX4 4PZ, United Kingdom; +44 (0)3005550444; I.P.L.McLaren@exeter.ac.uk), ref: 520569 |
| Health condition(s) or problem(s) studied | Emotional wellbeing |
| Intervention | A Phase II single centre feasibility RCT with embedded pilot where participants will be randomly selected to the 2 arms (sbLICBT vs delayed treatment control – block randomized 30 participants per arm) which will be conducted automatically by means of a secure service created and managed by the Exeter Clinical Trials Unit (CTU) in conjunction with the trial statistician. Block randomization will continue until 120 participants are randomized. One intervention group. Written strength-based CBT intervention with choice of support on demand (email, face to face [in person v. videoconference]) for up to 6 weeks. Control is delayed treatment control. |
| Intervention type | Behavioural |
| Primary outcome measure | Feasibility outcomes at measured using participant records up to 3 months follow-up: 1. Number of people directed to this research study 2. Number meeting inclusion criteria 3. Number of people consented 4. Demographic information 5. Number randomised 6. Study drop-out 7. Number completing outcome measures 8. Semi-structured interviews will determine intervention acceptability |
| Secondary outcome measures | Measured at 3 month follow up: 1. Resilience is measured by the Brief Resiliency Scale (BRS) 2. Depression is measured by PHQ9 3. Anxiety is measured by GAD-7 4. Functioning is measured by Work and Social Adjustment Scale (WSAS) |
| Overall study start date | 01/09/2021 |
| Completion date | 31/03/2026 |
Eligibility
| Participant type(s) | Learner/student |
|---|---|
| Age group | Mixed |
| Lower age limit | 16 Years |
| Sex | Both |
| Target number of participants | 120 |
| Key inclusion criteria | 1. Aged 16 years old or over 2. PHQ9=<9; GAD7=<9 3. Suicide risk: PHQ9; Q9=<1 and R2=No and R3= No 4. Resident in the UK 5. Student at the University of Exeter |
| Key exclusion criteria | Current participant exclusion criteria as of 14/08/2023: 1. Aged < 16 years old 2. PHQ9>9; GAD7>9 3. Suicide risk: PHQ9; Q9>1 and R2=Yes and/or R3 =Yes 4. Past history of psychosis, mania, substance/alcohol dependence Previous participant exclusion criteria: Past history of psychosis, mania, substance/alcohol dependence |
| Date of first enrolment | 10/07/2023 |
| Date of final enrolment | 16/12/2024 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Psychology
University of Exeter
Exeter
EX4 4QG
United Kingdom
Sponsor information
University/education
Research Ethics and Governance Office
Lafrowda House
St Germans Road
Exeter
EX4 6TL
England
United Kingdom
| Phone | +44 1392 723588 |
|---|---|
| p.r.baxter2@exeter.ac.uk | |
| Website | http://www.exeter.ac.uk/cgr/researchethics |
"ROR" |
https://ror.org/03yghzc09 |
Funders
Funder type
Research council
Government organisation / National government
- Alternative name(s)
- Medical Research Council (United Kingdom), UK Medical Research Council, MRC
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/03/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in publicly available repository |
| Publication and dissemination plan | Intention is to publish results in peer reviewed journals, presentation at a relevant conference and results will be available on Nurture-U web site when online. |
| IPD sharing plan | The datasets analysed during the current study will be stored in a publicly available repository called DATAMIND. The datasets will be anonymised and will be available indefinitely from March 2026. Requests for access to use the datasets will be governed by DATAMIND and the Nurture-U trial team. Participants have consented to their data being shared and/or used in future research. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | version 1.0 | 05/06/2023 | 14/08/2023 | No | No |
Additional files
Editorial Notes
01/07/2025: The IPD sharing plan and summary were added, and the intention to publish date was changed from 30/06/2025 to 31/03/2026.
25/11/2024: The recruitment end date was changed from 30/11/2024 to 16/12/2024.
03/06/2024: The overall end date was changed from 30/11/2024 to 31/03/2026.
14/08/2023: The following changes have been made and the plain English summary updated accordingly:
1. Uploaded protocol (not peer reviewed).
2. The public title was changed from "ERUS: Enhancing resiliency in university students" to "Bounce Back: Enhancing resiliency in university students".
3. The acronym was changed from "ERUS" to "Bounce Back".
4. University/medical school/dental school was added as a study setting.
5. The overall study start date was changed from 31/03/2022 to 01/09/2021.
6. The overall study end date was changed from 30/06/2024 to 30/11/2024.
7. Learner/student was added as the participant type and other was removed.
8. The participant exclusion criteria were changed.
9. The recruitment start date has been changed from 15/05/2023 to 10/07/2023.
10. The recruitment end date has been changed from 01/05/2024 to 30/11/2024.
22/02/2023: The recruitment start date has been changed from 01/03/2023 to 15/05/2023.
13/01/2023: The recruitment start date has been changed from 16/01/2023 to 01/03/2023.
03/11/2022: The recruitment start date was changed from 01/11/2022 to 16/01/2023.
25/10/2022: Trial's existence confirmed by University of Exeter REC.
