Nurture-U Treating Anxiety and Depression: internet-based cognitive-behavioural therapy for anxiety and depression in UK university students
| ISRCTN | ISRCTN56784470 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN56784470 |
| Secondary identifying numbers | MR/W00242/1/3 |
- Submission date
- 11/10/2022
- Registration date
- 27/10/2022
- Last edited
- 25/11/2024
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Mental and Behavioural Disorders
Plain English Summary
Background and study aims
This project seeks to find out which forms of digital therapy students prefer and to understand which therapy works best for whom. Many universities offer some form of digital cognitive-behavioural therapy (CBT) for students who have anxiety and/or depression. This is because there is good evidence that these cognitive-behavioural therapy treatments can be effective. These treatments usually involve a combination of changing what you do (e.g., building up positive activities, reducing avoidance of anxiety-provoking situations) and changing how you think (e.g., spotting and challenging negative thoughts). These therapies can be offered as a treatment that the individual works through on their own or with support from a mental health professional. Some people prefer to complete the treatment on their own: there are no waiting lists, it is completely private, and you can access it when you want. However, for other people, support from a professional may be necessary and a critical part of helping them to recover.
We want to find out who does well with digital CBT on their own and who would only benefit when they have support from a therapist. Digital CBT without a therapist can be offered to a really large number of students as there is no limit on capacity based on therapist availability or scheduling, so it is important to know who can benefit just as well from this approach. Equally, we want to know who really needs the support of a therapist so we can make sure they get the right help. This research will therefore help us to improve services by better directing students to the right treatment, and by better planning and resourcing the services required to help the maximum number of students.
Who can participate?
University students (undergraduate or postgraduate, above the age of 16 years) in the UK, principally students at the Universities of Exeter, Oxford, Cardiff, Newcastle, Southampton, or King’s College London (as the participating universities in Nurture-U project), although students at other universities can participate.
What does the study involve?
We ask participants to complete brief questions about symptoms of anxiety and depression and well-being twice online. These questions will be asked at the start of the study and then at a follow-up after 3 months. These measures should take about 10-15 minutes to complete each time. We also ask participants to complete very brief measures (taking about 1-2 minutes) once a week for the first 8 weeks after the baseline. These measures will help us to understand what is helpful or not helpful.
At the start of the study, we will ask participants to complete a comprehensive set of questions about their physical and mental health, prior life experiences, demographics, family background, current and past stress, personality and coping skills, social relationships, and attitudes to and experience of therapy. This will take about 30-40 minutes to complete. These questions are critically important because they will help us to predict who might do better in which version of the digital CBT therapy. These questions have been found to predict who does well in therapy before and so we are using them to develop statistical models of who might benefit from the different versions of CBT.
We will offer half of the study participants the option of using digital cognitive-behavioural therapy to reduce anxiety and depression on their own (self-directed) and half of the study participants the option to use digital cognitive-behavioural therapy with the support of a therapist. This support could take the form of video-conferencing, emails or online conversations within the digital therapy platform, approximately once a week. The therapy typically takes 6-8 weeks to complete and we recommend completing one module a week plus practice in between each module. This allocation will be decided by chance (at random). This is so we can learn who might benefit most from each version of the therapy.
What are the possible benefits and risks of participating
By taking part, participants play a major role in improving the well-being and mental health of university students. Taking part may help participants learn about, understand, and better manage their own anxiety and depression. Digital treatments have been proven to be on average effective and so they may be of benefit to them. These interventions are provided to participants for free. It will also help us to improve treatment and services for anxiety and depression for other university students.
Taking part involves participants giving their time to complete the questionnaires and use the digital therapy. Because some of the questions in the assessment ask about past and present negative emotions and difficult experiences, and the therapy asks participants to tackle current difficulties, there is a small chance that this may produce mild and brief upset if they are reminded of an unpleasant event. However, this would be no more than usually experienced in daily life. We are not aware of any other side effects, disadvantages, or risks of using the digital treatment.
Where is the study run from?
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?
1. UK Research and Innovation (UK)
2. Medical Research Council (MRC) (UK)
Who is the main contact?
Prof. Ed Watkins, teamnurture-u@exeter.ac.uk
Contact information
Principal Investigator
Sir Henry Wellcome Building for Mood Disorders Research
University of Exeter
Queens Drive
Exeter
EX4 4QQ
United Kingdom
 ORCID ID |
0000-0002-2432-5577 |
|---|---|
| Phone | +44 (0)1392 724692 |
| teamnurture-U@exeter.ac.uk |
Scientific
Sir Henry Wellcome Building for Mood Disorders Research
University of Exeter
Queens Drive
Exeter
EX4 4QQ
United Kingdom
| Phone | +44 (0)1392 724692 |
|---|---|
| teamnurture-U@exeter.ac.uk |
Public
Sir Henry Wellcome Building for Mood Disorders Research
University of Exeter
Queens Drive
Exeter
EX4 4QQ
United Kingdom
| Phone | +44 (0)1392 724692 |
|---|---|
| teamnurture-U@exeter.ac.uk |
Study information
| Study design | Phase III superiority parallel two-arm randomized multicentre 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 contact details to request a participant information sheet |
| Scientific title | Developing and evaluating a stepped change whole-university approach for student wellbeing and mental health: Nurture-U trial of unguided versus guided internet cognitive-behavioural therapy for acute depression and anxiety in students |
| Study acronym | Internet CBT |
| Study hypothesis | Current study hypothesis as of 15/08/2023: The aims of the study: To better understand the heterogeneity of digital cognitive-behavioural therapy (CBT) intervention effects for students: 1. Explore which subgroups of students with elevated anxiety and depression are particularly responsive to unguided digital interventions 2. Identify predictors of who benefits from guided versus unguided digital CBT interventions for anxiety and depression 3. Produce exploratory individualised treatment rules (ITRs) to guide the selection of treatments most likely to be helpful for students with anxiety and depression through the use of machine-learning approaches Hypotheses: For university students with depression and/or anxiety, on average, guided transdiagnostic i-CBT will outperform unguided transdiagnostic i-CBT at: 1. Reducing symptoms of depression at 3 months (1a; co-primary outcome, as an index of poor mental health; Patient Health Questionnaire-9 [PHQ-9]) 2. Reducing symptoms of anxiety at 3 months (2a); (co-primary outcome, as an index of poor mental health; Generalised Anxiety Disorder Assessment [GAD-7]) 3. Improving rates of recovery (defined as both GAD-7 ≤9 and PHQ-9 <=9) 4. Increasing mental well-being (WEMWBS), social and occupational/academic functioning (WSAS), academic outcomes) at 3 months (2c) (secondary outcome) It is further hypothesized that whilst guided i-CBT will on average be more efficacious than unguided I-CBT, for a subset of users there will be no difference in effectiveness. The aim is to identify the profiles of those students who would benefit most from unguided i-CBT relative to guided i-CBT and those that need to be directed to guided i-CBT interventions. Previous study hypothesis: The aims of the study: To better understand the heterogeneity of digital cognitive-behavioural therapy (CBT) intervention effects for students: 1. Explore which subgroups of students with elevated anxiety and depression are particularly responsive to unguided digital interventions 2. Identify predictors of who benefits from guided versus unguided digital CBT interventions for anxiety and depression 3. Produce exploratory individualised treatment rules (ITRs) to guide the selection of treatments most likely to be helpful for students with anxiety and depression through the use of machine-learning approaches Hypotheses: For university students with depression and/or anxiety, on average, guided transdiagnostic i-CBT will outperform unguided transdiagnostic i-CBT at: 1. Reducing symptoms of depression at 3 months (1a; primary outcome, as an index of poor mental health; Patient Health Questionnaire-9 [PHQ-9]) 2. Reducing symptoms of anxiety at 3 months (2a); (secondary outcome, as an index of poor mental health; Generalised Anxiety Disorder Assessment [GAD-7]) 3. Increasing mental well-being (WEMWBS), social and occupational/academic functioning (WSAS), academic outcomes) at 3 months (2c) (secondary outcome) It is further hypothesized that whilst guided i-CBT will on average be more efficacious than unguided I-CBT, for a subset of users there will be no difference in effectiveness. The aim is to identify the profiles of those students who would benefit most from unguided i-CBT relative to guided i-CBT and those that need to be directed to guided i-CBT interventions. |
| Ethics approval(s) |
Approved 27/09/2022, CLES Psychology Ethics Committee (Queens Drive, Exeter, EX4 4PZ, United Kingdom; +44 (0)3005550444; I.P.L.McLaren@exeter.ac.uk), ref: 520569 |
| Ethics approval additional information | Approved 27/09/2022, Faculty of Health and Life Sciences Psychology Ethics Committee (Psychology, University of Exeter, Washington Singer Building, Perry Road, Exeter, EX4 4QG, UK; Tel: not available; c.civile@exeter.ac.uk, i.p.l.mclaren@exeter.ac.uk), ref: 523095 |
| Condition | Depression and anxiety |
| Intervention | Two intervention groups: unguided transdiagnostic online CBT for anxiety and depression (i.e., without any therapist support); guided transdiagnostic online CBT for anxiety and depression (i.e., with therapist support from psychological wellbeing practitioner – typically online, asymmetric support). Treatment duration is typically completed over 6-12 weeks, with a 3-month follow-up. Randomisation to the two arms (unguided vs guided i-CBT) is conducted automatically via a secure service created and managed by Exeter Clinical Trials Unit (ExeCTU). |
| Intervention type | Behavioural |
| Primary outcome measure | Current primary outcome measure as of 15/08/2023: Depression is measured using the PHQ-9 and anxiety is measured using the GAD-7 across the 3- month follow up Previous primary outcome measure: Depression is measured using the PHQ-9 across the 3-month follow up |
| Secondary outcome measures | 1. Worry is measured by the short-form Penn State Worry Questionnaire at 3 months 2. Rumination is measured by the 5-item Brooding Scale at 3 months 3. Resilience is measured by the Brief Resilience Scale at 3 months 4. Stress is measured by the Perceived Stress Scale-7 and an abbreviated version of the post-secondary student stressors index at 3 months 5. Use of services/treatment received is self-reported at 3 months 6. Treatment satisfaction is measured with the Adapted Client Satisfaction Questionnaire – Internet-based interventions at 3 months 7. Self-report of use of intervention at 3 months |
| Overall study start date | 01/09/2021 |
| Overall study end date | 31/03/2026 |
Eligibility
| Participant type(s) | Other |
|---|---|
| Age group | Mixed |
| Lower age limit | 16 Years |
| Sex | Both |
| Target number of participants | 720 for whole cohort |
| Participant inclusion criteria | 1. Aged 16 years plus based in the UK, attending university (predominantly one of the six partner universities: Exeter, Oxford, Southampton, Cardiff, Newcastle, King’s College London or other HE institution or associated HE institution, e.g., Falmouth University for University of Exeter) 2. Reporting PHQ-9>9 and/or GAD-7 >9 3. Basic literacy in English as indicated by ability to complete consent and online questionnaires (12-year-old reading age or better) 4. Ability to provide informed consent 5. Available for the full duration of the study (3 months) 6. Regular access to a relevant smartphone/tablet/laptop or PC able to run the intervention (using Android or IOS systems) |
| Participant exclusion criteria | 1. Meeting criteria on self-report electronic screening questionnaires for any of the following: 1.1. Active suicidality 1.2 Any history of severe mental health problems (i.e., bipolar/psychosis/mania/drug/alcohol dependence) 2. Currently receiving psychological therapy or counselling 3. Currently receiving antidepressants or other psychiatric medication that has been changed within the last 4 weeks (in this instance the participant has the option to join the trial once stable for 4 weeks) |
| Recruitment start date | 10/07/2023 |
| Recruitment end date | 31/05/2025 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Perry Road
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 (0)1392 723588 |
|---|---|
| p.r.baxter2@exeter.ac.uk | |
| Website | http://www.exeter.ac.uk/cgr/researchethics |
"ROR" |
https://ror.org/03yghzc09 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- UKRI
- Location
- United Kingdom
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 | 01/03/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | The trial protocol, full trial report, anonymised participant-level dataset, and statistical code for generating the results will be made publicly available. The researchers' publication policy stipulates that all potential publication plans need to be reviewed by the Project Steering Committee before release of data to coordinate activity between partners, determine appropriate authorship and avoid duplication and replication of effort. |
| IPD sharing plan | The data-sharing plans for the current study are unknown and will be made available at a later date |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | version 2.0 | 05/06/2023 | 15/08/2023 | No | No |
Additional files
Editorial Notes
25/11/2024: The recruitment end date was changed from 11/05/2025 to 31/05/2025.
03/06/2024: The following changes were made to the trial record:
1. The recruitment end date was changed from 01/11/2024 to 11/05/2025.
2. The overall end date was changed from 01/03/2025 to 31/03/2026.
3. The plain English summary was updated to reflect these changes.
15/08/2023: The following changes were made:
1. Uploaded protocol (not peer reviewed).
2. An acronym was added.
3. The study hypothesis has been changed.
4. University/medical school/dental school was added as a study setting.
5. The overall study start date was changed from 10/01/2022 to 01/09/2021 and the plain English summary updated accordingly.
6. The primary outcome measure was changed.
7. The recruitment start date has been changed from 15/05/2023 to 10/07/2023.
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.
28/10/2022: Internal review.
25/10/2022: Trial's existence confirmed by the Faculty of Health and Life Sciences Psychology Ethics Committee.
