Testing online, self-help single session interventions for UK young people with low mood: the Unlock Wellbeing trial
| ISRCTN | ISRCTN90050599 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN90050599 |
| NIHR Advanced Fellowship | 302929 |
| Sponsor | University of Bath |
| Funder | National Institute for Health and Care Research |
- Submission date
- 11/02/2026
- Registration date
- 17/02/2026
- Last edited
- 16/02/2026
- Recruitment status
- Not yet recruiting
- Overall study status
- Ongoing
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
Young people have told us that they would like help with low mood, stress and worry. We are testing whether doing a single session intervention (which is an online activity or mini-course done just one time) could actually help change the way young people think and feel, and help them cope better. In this project, we have three different single-session interventions, and the one you do will be picked at random. These interventions have been developed and tested in the USA by Northwestern University. We want to see how these interventions benefit young people in the UK.
Who can participate?
Adolescents aged 13-18 years, who live in the UK, and are experiencing at least some depressive symptoms (score of ≥ 2 on the Patient Health Questionnaire-2 item (PHQ-2) questionnaire).
What does the study involve?
This study is fully online, and you will not need to talk to anybody to take part. The study will be split into 4 parts.
These are the 4 parts:
Part 1: Answer some questions about yourself, and the way that you think and feel. This will include questions about you, like your sexual orientation, gender identity and ethnicity, and about your feelings, like worries and mood. This part will take around 10-15 minutes.
Part 2: Complete a single-session intervention online, including listening to/reading some information and learning about what science tells us about how to deal with low mood, stress and worry. Each single session intervention will take around 15-20 minutes.
Part 3: Answer some more questions about your feelings and about how you found the intervention (part 2). This is important as it will help us to understand if this intervention has been useful to you, and also to get your thoughts and ideas about how we could improve it. This part will take around 5 minutes.
Part 4: 1 month and 6 months after you have completed the intervention, we will send you an email asking you to complete a survey.
All research procedures and assessments will be on the REDCap survey platform (for answering questionnaires) and the Qualtrics survey platform (for administering interventions, which are self-guided). Recruitment will be aimed at the general public through social and mass media adverts, and through community organisations, including schools, voluntary and third sector organisations, particularly those offering anonymous/early help. These adverts will signpost and direct potential participants to our codesigned website, www.unlockwellbeing.org.uk, where more information will be presented in an engaging way, together with a link to access the REDCap project housing all further research activities.
What are the possible benefits and risks of participating?
What are the benefits of taking part?
We do not know for sure whether taking part in this study will help you. The intervention you complete might help you to find new ways to manage your feelings and thoughts. By being in this study, you could help other people. We hope to use what we learn from this study to help and support other young people like you in the future. Participants who pass our checks and complete the 1-month survey will receive a £10 shopping voucher, and those who complete the 6-month survey will receive a £5 voucher.
What are the risks of taking part?
It is possible that you might feel uncomfortable or sad when answering personal questions. You may stop or take a break at any time, and you can skip most questions you do not want to answer.
Where is the study run from?
The University of Bath, UK.
When is the study starting and how long is it expected to run for?
12m set-up (March 2025-February 2026)
12m recruitment (March 2026-February 2027)
6m last participant last follow-up (August 2027)
Data cleaning, analysis and write-up (March 2027-June 2028)
Who is funding the study?
This trial is funded by an NIHR Advanced Fellowship awarded to the Chief Investigator, Prof Maria Loades. This trial is sponsored by the University of Bath, UK.
Who is the main contact?
The Chief Investigator is Prof Maria Loades, lamp@bath.ac.uk.
Contact information
Principal investigator, Scientific, Public
University of Bath, Claverton Down
Bath
BA2 7AY
United Kingdom
 ORCID ID |
0000-0002-0839-3190 |
|---|---|
| Phone | +44 01225385249 |
| mel26@bath.ac.uk |
Study information
| Primary study design | Interventional | |
|---|---|---|
| Allocation | Randomized controlled trial | |
| Masking | Blinded (masking used) | |
| Control | Placebo | |
| Assignment | Parallel | |
| Purpose | Treatment | |
| Participant information sheet | 49018_PIS_V1.0_26Jan2026.pdf | |
| Scientific title | Unlock well-being trial of self-help single session interventions a widely available, scalable resource for UK young people with depression symptoms randomised control trial | |
| Study acronym | Unlock Wellbeing | |
| Study objectives | • Primary Objective (effectiveness): To evaluate the short-term effectiveness of two single-session interventions (SSIs) in reducing depressive symptoms at 1-month post-intervention among UK adolescents, compared to a placebo control SSI. • Secondary Objective (effectiveness): To evaluate the medium-term effectiveness of two single-session interventions (SSIs) in reducing depressive symptoms at 6-months post-intervention, and other mental health outcomes at 1- and 6-months post intervention among UK adolescents, compared to a placebo control SSI. • Secondary Objective (cost-effectiveness): To evaluate the costs of SSI. • Secondary Objective (implementation): To explore implementation outcomes through a process evaluation, focusing on (1) reach – exploring recruitment sources (including reach into underserved communities) and report the costs of various recruitment routes, (2) implementation including identification of key barriers and enablers to completing the SSI including how it was received and unexpected benefits and harms and (3) maintenance – to explore perceived mechanisms of change. | |
| Ethics approval(s) |
Approved 26/01/2026, University of Bath Biomedical Sciences REC (University of Bath, Claverton Down, Bath, BA2 7AY, United Kingdom; +44 01225388388; research-ethics@bath.ac.uk), ref: 13717-17119 | |
| Health condition(s) or problem(s) studied | Elevated depressive symptoms | |
| Intervention | The trial will compare 2 single-session interventions (SSIs) that contain presumed active ingredients of mental health change (Project Growth - growth mindset SSI; Project ABC - behavioural activation SSI) to an existing comparator SSI (Project Share – Sharing Feelings SSI), which does not contain a presumed active ingredient of change in adolescents with elevated depression symptoms. All three SSI are self-guided, web-based, and each takes approximately 15-20 minutes to complete. All have been used in trials in the USA with adolescents aged 13-16, with no emergent safety concerns and indication of benefit across multiple outcomes, including depression symptoms. The SSIs are embedded within the Qualtrics (electronic data capture) survey platform, and include psychoeducational materials in written and visual form, brief videos, vignettes, and self-reflexive exercises. There is some personalisation using branching logic. The content of the SSIs is based on four elements: B: Brain science - to normalize concepts in the programme, E: Empower adolescents to a “helper” or “expert” role, S: Saying-is-believing exercises to consolidate learning, and T: Testimonials and evidence from valued others. All the interventions were developed with input from young people by the Lab for Scalable Mental Health, led by Asst Prof Dr Jessica Schleider, Clinical Psychologist, in the USA. We have made several surface level adaptations based on 1) feedback from young people participants (age 13-18) who took part in pilot SSI studies (Project CARE and ABC) and gave feedback via the programme feedback scale; 2) our Young Persons Advisory Group, and 3) from internal user testing by the spotLight for Adolescent and young adult (LAMP) research team members. Our adaptations were similar across all 3 interventions and were as follows: - changing terms from US to UK terms (e.g. soccer to football), - changing examples to those more relatable to UK adolescents (e.g. baseball to football), - based on feedback that the American versions were too text-heavy, with recommendations to make the text more accessible and easier to digest, we chunked the text more, reduced unnecessary repetition and made some of the case examples more concise, without changing the underlying meaning. - removing references to social distancing that had been in place during the COVID-19 pandemic, - re-recording all the voiceovers using British English young people speakers, - updating some of the graphics to be more consistent within and across interventions. Active conditions Project Growth: Growth Mindset SSI (GM-SSI) The key message of this SSI is that change is possible because people’s traits or habits are malleable rather than fixed. When used in the USA, this SSI has been called “Project Personality”, although we will call it Project Growth, based on feedback from young people advisors in the UK. It includes: An introduction to the brain and psychoeducation about neuroplasticity and plasticity and why personality can change; testimonials from older young people who describe their perceptions of their traits being malleable due to the brain's plasticity, and describe times when they adopted "growth mindsets" to persevere during social/emotional challenges and an exercise in which young people write a note to a younger students, using what they have learned in the SSI to explain people's capacity for change. See all materials for the US version of this intervention here: https://osf.io/a9uv2/. The SSI had been adapted previously for use in the UK by Prof Roz Shafran’s team. A master’s student initially sought qualitative feedback from stakeholders, including clinicians and young people and made initial adaptations. The language was adjusted to reflect British terminology and phrasing, and the audio narration was re-recorded. Stories from young people of varying ages were incorporated to increase relatability. It was then piloted with 8- to 16-year-olds in the UK and was used by Clarkson et al. Feedback indicated that users generally found the SSI to be engaging, accessible, and visually appealing, and they liked the audio narration. They found the neuroscience content interesting, and stories from other young people helped normalize experiences, though some noted a lack of diversity. Many felt empowered by giving advice, gained hope for change, and saw the intervention as a first step toward improvement. A few users were less engaged, and suggestions included adding clearer strategies and takeaway materials. We drew from the UK adaptation of this SSI when adapting our intervention materials for the Unlock Wellbeing Trial. Project Action Brings Change (ABC): Behavioural Activation SSI (BA-SSI) This SSI teaches that engaging in valued activities can increase positive mood. This SSI has also been referred to as “Activate action” and Project A.B.C. (Action Brings Change). The BA-SSI comprises five key elements: (1) an explanation of how engaging in activities aligned with personal values can help alleviate feelings of sadness and low self-esteem, (2) psychoeducation about the relationship between behaviour, feelings, and thoughts in the context of depression, (3) an assessment of life values in which young people are asked to identify significant areas of life (such as family relationships, friendships, school, or hobbies) from which they derive or once derived enjoyment and meaning, (4) developing an activity hierarchy by selecting and personalising three activities for change from pre-generated lists through guided exercises, and (5) A Benefit, Obstacle, Strategy Exercise in which participants write about the potential benefits of engaging in each activity, obstacles they may face, and strategies for overcoming these obstacles. See all materials for the US version of this intervention here: https://osf.io/ch2tg/. This SSI was used in one RCT with US adolescents and in two open-platform (non-randomised) studies. It had not previously been adapted for use in the UK; we initially made some adaptations to language (e.g. ‘soccer’ to ‘football’) before using it in our UK pilot study. Comparator condition Project Share: Sharing Feelings Supportive Therapy SSI (ST-SSI) The Sharing Feelings Intervention, also known as Project Share, closely resembles other SSIs in structure but is specifically designed to imitate supportive therapy (ST). Unlike interventions that focus on teaching specific evidence-based skills or beliefs, ST aims to prompt participants to identify and express their emotions to those close to them. The ST-SSI is structured to control for nonspecific intervention factors, such as engagement with a computer program. It incorporates a similar number of elements, such as reading and writing activities, as well as vignettes written by older college students to illustrate the benefits of sharing their feelings with close ones. For the US version, see https://osf.io/u4axs/. Previous clinical studies have found that the ST-SSI leads to significantly smaller reductions in depression symptoms in adolescents compared to the BA-SSI and the GM-SSI. | |
| Intervention type | Other | |
| Primary outcome measure(s) |
| |
| Key secondary outcome measure(s) | ||
| Completion date | 30/09/2027 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Mixed |
| Lower age limit | 13 Years |
| Upper age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 470 |
| Key inclusion criteria | 1. Adolescents aged 13-18 2. Who live in the UK, 3. Who report elevated depressive symptoms - score of ≥ 2 on the Patient Health Questionnaire—2 item version (PHQ-2), 4. Are fluent in English, 5. Have internet access. 6. Can complete informed consent procedure |
| Key exclusion criteria | 1. Individuals who do not meet prespecified quality criteria, designed to detect bots (i.e., automated form fillers) and random responders. 2. Individuals who are actively suicidal will also be excluded. |
| Date of first enrolment | 02/03/2026 |
| Date of final enrolment | 01/03/2027 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Bath
BA2 7AY
England
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not expected to be made available |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version 1.0 | 26/01/2026 | 16/02/2026 | No | Yes |
Additional files
- 49018_PIS_V1.0_26Jan2026.pdf
- Participant information sheet
Editorial Notes
16/02/2026: Study’s existence confirmed by the University of Bath Biomedical Sciences Research Ethics Committee, UK.
