ABC-UK: Single session self-help
| ISRCTN | ISRCTN38416977 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN38416977 |
| Integrated Research Application System (IRAS) | 369975 |
| Central Portfolio Management System (CPMS) | 73684 |
| Sponsor | University of Bath |
| Funder | National Institute for Health and Care Research |
- Submission date
- 06/04/2026
- Registration date
- 17/04/2026
- Last edited
- 17/04/2026
- Recruitment status
- Not yet recruiting
- Overall study status
- Ongoing
- Condition category
- Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Background and study aims
Many young adults experience low mood or depression, but it can be difficult to access timely support. Brief online tools that can be completed in one sitting may offer a simple and accessible way to help. This study aims to find out whether a short online activity, based on helping people do more meaningful and enjoyable activities, can improve mood in young adults compared to usual support alone.
Who can participate?
Young adults aged 19 to 25 years living in the UK, who are experiencing low mood, can take part. Participants must be able to read English and have access to the internet.
What does the study involve?
Participants will complete an online screening questionnaire and, if eligible, will be asked to give consent and complete a baseline survey. They will then be randomly assigned (by chance) to one of two groups. One group will receive access to a short online activity (around 15–20 minutes) designed to help improve mood, in addition to usual support. The other group will receive usual support only, including access to a list of mental health resources. Participants will be asked to complete follow-up questionnaires after 1 month and 6 months.
What are the possible benefits and risks of participating?
Participants may benefit from taking part in the online activity, which is designed to support mood and wellbeing. However, this cannot be guaranteed. Some questions may feel personal or sensitive, and thinking about mood or mental health may cause temporary discomfort. Participants will be provided with information about sources of support if needed.
Where is the study run from?
The study is run by the University of Bath in the United Kingdom.
When is the study starting and how long is it expected to run for?
The study is expected to start in 2026 and will run for approximately 12–18 months, including recruitment and follow-up.
Who is funding the study?
The study is funded by the NIHR Bath Mental Health Research Group.
Who is the main contact?
Dr Jeffrey Lambert, University of Bath
jl2426@bath.ac.uk
Contact information
Dr Jeffrey Lambert
Scientific, Principal investigator, Public
Scientific, Principal investigator, Public
Claverton Down
Bath
BA2 7AY
United Kingdom
 ORCID ID |
0000-0003-4774-9054 |
|---|---|
| Phone | +44 1225 388388 |
| jl2426@bath.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Allocation | Randomized controlled trial |
| Masking | Open (masking not used) |
| Control | Active |
| Assignment | Parallel |
| Purpose | Treatment |
| Scientific title | The ABC-UK Randomised Controlled Trial for young adults with depression symptoms (ABC-UK RCT) |
| Study acronym | ABC-UK RCT |
| Study objectives | Primary objective: To determine whether the ABC-UK SSI, in addition to enhanced usual care, results in a reduction in depression symptoms 1-month post-intervention in young adults in the UK compared to enhanced usual care alone (effectiveness RCT). The hypothesis is that the ABC-UK SSI added to enhanced usual care will be superior to enhanced usual care alone Secondary objectives: 1. Determine whether the ABC-UK SSI, in addition to enhanced usual care, reduces depression symptom severity at 6 months post-intervention, and whether it reduces anxiety symptom severity, b) improves functioning and c) increases mental well-being at 1 month and 6 months 2. Undertake a health economic evaluation to determine the cost-effectiveness of the ABC-UK SSI 3. Complete a process evaluation to establish where young adults are recruited from, and interest, uptake, engagement, completion and experience of the intervention and trial 4. To determine whether any adverse events and/or harms are reported among participants who complete the ABC‑UK RCT |
| Ethics approval(s) |
Approved 23/03/2026, University of Bath’s Biomedical Sciences Research Ethics Committee (University of Bath, Claverton Down, Bath, BA2 7AY, United Kingdom; +44 1225 388388; biomedical-rec@bath.ac.uk), ref: 14646-19095 |
| Health condition(s) or problem(s) studied | Treatment of depressive symptoms in young adults |
| Intervention | Randomisation will be implemented using the REDCap survey platform. An independent statistician from the Bristol Trials Centre will generate an allocation list, which will be uploaded to the REDCap randomisation module. Participants will be allocated to one of two intervention conditions, the ABC-UK SSI in addition to enhanced usual care, or enhanced usual care only, on a 1:1 ratio. No member of the research team will have access to the underlying allocation sequence or any function that would allow the prediction of future assignments. No stratification or minimisation procedures will be applied. Within the REDCap survey editor, two blocks corresponding to the two conditions will be created. Randomisation will occur immediately after completion of baseline measures, ensuring allocation is concealed until the participant’s allocation is assigned. Intervention The Behavioural Activation SSI, also known as Project Action Brings Change (ABC), is a web-based, self-guided programme that takes approximately 15 to 20 minutes to complete. It is embedded within the Qualtrics online platform and incorporates psychoeducational materials in written and visual formats, brief videos, vignettes, and self-reflective exercises. Personalisation is achieved using branching logic, tailoring some elements to participants’ responses. Participants randomised to the intervention arm will receive access to the BA-SSI in addition to enhanced care as usual (i.e. usual care and a mental health resource list provided to all participants). The content of SSIs for adolescent and young adult mental health are structured around four key components (Schleider et al., 2020) B: Brain science – providing credibility for concepts presented in the programme. E: Empowerment - positioning SSI completers in a helper/expert role. S: Saying-is-believing exercises - consolidating learning through active engagement. T: Testimonials - providing evidence and perspectives from valued others. The ABC-UK SSI uses the principles of behavioural activation to encourage individuals to engage in value-driven activities in order to improve positive mood. The intervention comprises five core elements: 1. Rationale: introduces the idea that participating in meaningful activities, aligned with your individual values can reduce low mood and low self-esteem. 2. Psychoeducation: Information about the interconnection between behaviour, feelings, and thoughts 3. Values assessment: Asking individuals to identify meaningful areas of life (e.g., family, friendships, academics, hobbies) that currently or previously brought enjoyment and purpose. 4. Activity hierarchy: Guiding individuals to select and personalise three value-based activities for change from pre-generated lists. 5. Benefit–Obstacle–Strategy Exercise: Encouraging individuals to identify potential benefits of engaging in each activity, anticipate obstacles, and develop strategies to overcome them. Participants will be able to access the ABC-UK SSI immediately following randomisation. Following initial completion, participants will be able to re-access the intervention materials via a persistent link provided at the end of the SSI and in follow-up communications (e.g., email reminders), enabling them to revisit and reinforce key concepts and planned activities over time. Comparator The comparator condition will be ‘enhanced usual care’. This refers to any mental health support, services or resources that a participant would typically access in addition to a standardised mental health resource list provided to all participants at the end of the baseline survey as well as at the end of both follow up surveys as part of the trial. It is not possible to define enhanced usual care precisely asthere is considerable potential for variability between what care participants will access, as there is no singular pathway of care for young adult mental health. Additionally, some participants may not engage with any mental health care across the duration of the trial, whilst other participants may engage with a range of supports and services. As part of enhanced care as usual, all participants (in both trial arms) will receive a curated list of mental health resources, including national and local services, which they can access at any time during the study. The support, services and resources that participants may engage with as part of enhanced usual care include, but are not limited to: - NHS mental health services (e.g., Talking Therapies, Improving Access to Psychological Therapies (IAPT)). - Primary care support (e.g., GP appointments, prescription medication for psychiatric symptoms) - Third-sector/voluntary sector support (e.g., Mind, Shout, Samaritans, Kooth) - Educational or workplace support, such as staff/student well-being services - Informal support from peers, family and local community groups - Accessing self-help resources - Participants randomised to the intervention arm will receive access to the ABC-UK single-session intervention (SSI) in addition to enhanced care as usual. Following completion of the 6-month follow-up assessment, participants allocated to the comparison arm will be offered access to the ABC-UK SSI. |
| Intervention type | Behavioural |
| Primary outcome measure(s) |
|
| Key secondary outcome measure(s) |
|
| Completion date | 04/10/2027 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Adult |
| Lower age limit | 19 Years |
| Upper age limit | 25 Years |
| Sex | All |
| Target sample size at registration | 264 |
| Total final enrolment | 264 |
| Key inclusion criteria | 1. Aged 19 to 25 years 2. Currently living in the United Kingdom 3. Able to read and understand English 4. Reporting elevated depressive symptoms, defined as a score of ≥2 on the Patient Health Questionnaire-2 (PHQ-2) 5. Access to the internet via a computer, tablet, or smartphone 6. Willing and able to provide informed consent online |
| Key exclusion criteria | 1. Not meeting the inclusion criteria 2. Failing predefined data quality checks designed to identify random, inattentive, or non-human (e.g. bot) responses 3. Use of automated or fraudulent responses identified through safeguards such as reCAPTCHA, IP checks, honeypot items, and attention-check questions 4. Reporting active suicidal intent, defined as answering “Yes” to the question “Are you having thoughts of killing yourself right now?” |
| Date of first enrolment | 20/04/2026 |
| Date of final enrolment | 01/04/2027 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
University of Bath
Claverton Down
Bath
BA2 7AY
England
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? |
|---|---|---|---|---|---|
| Protocol file | version 1.2 | 08/04/2026 | 08/04/2026 | No | No |
Additional files
- 49234 ABC-UK RCT Protocol Draft v1.2 08.04.26.pdf
- Protocol file
Editorial Notes
07/04/2026: Trial's existence confirmed by University of Bath.
