To create and evaluate an online support programme that will use young people’s smartphones to detect and treat early onset sleep problems and early mental health problems
| ISRCTN | ISRCTN14480620 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14480620 |
| IRAS number | 321940 |
| Secondary identifying numbers | IRAS 321940 |
- Submission date
- 11/11/2022
- Registration date
- 17/11/2022
- Last edited
- 15/04/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
The majority (60-70%) of young people’s mental health problems go undetected and untreated despite the existence of effective interventions for both treatment and prevention. Young people don’t seek help because they are either unaware of their symptoms or risk, have concern about stigma, or have limited/no access to mental health services. Identifying insomnia symptoms is an innovative mechanism to identify young people at risk, and those with early onset mental health problems. Most young people with mental health problems have symptoms of insomnia (e.g., difficulty getting to sleep, waking at night and finding it hard to go back to sleep, waking frequently or waking early). Insomnia symptoms increase the risk for developing subsequent mental health disorders 2-4 fold. Adolescents with three insomnia symptoms have a 6-fold increased risk of suicidal ideation, a 10-fold increased risk of a suicide attempt and an increased risk of completing suicide.
The study aims to develop and optimise a novel, accessible, engaging public health intervention (STTAMP). This will be ready in 2025 to be used at scale to identify young people (aged 14-18) developing mental health problems early and offer them immediate access to effective treatment online.
Who can participate?
14 – 18 year olds from participating schools and colleges.
What does the study involve?
Participants will download an app which will monitor their sleep for 6 weeks. Those found to have early signs of insomnia will be offered three interventions: (1) advice in the form of engaging audio / visual modules, (2) an adapted teen version of the effective adult SHUTi program and (3) effective automated online and signposting to NHS treatment. All participants will be asked to complete 6 and 12 month questionnaires and some participants will be interviewed to discover their experiences of the study. Participants will take part in the study for 1 year and the total duration of follow-up is expected to be 29 months.
What are the possible benefits and risks of participating?
Benefits include free access to a new sleep tracker app, a 3-step intervention package designed to improve sleeping and mental health and increased self-worth by being part of a nationwide research project improving the quality of life of many young people_
Risks: Participants could experience stress and anxiety from participating in the study: from their phoned passively monitoring their sleep, completing questionnaires or taking part in research interviews.
Where is the study run from?
University of Bristol (UK)
When is the study starting and how long is it expected to run for?
July 2022 to January 2026
Who is funding the study?
The Prudence Trust (UK)
University of Bristol (UK)
Who is the main contact?
Nicholas Christoforou, n.christoforou@bristol.ac.uk
Contact information
Public
Centre for Academic Child Health
Canynge Hall
39 Whatley Road
Bristol
BS8 2PS
United Kingdom
| Phone | +44 117 4552354 |
|---|---|
| n.christoforou@bristol.ac.uk |
Study information
| Study design | Interventional non randomized |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | School |
| Study type | Quality of life |
| Participant information sheet | ISRCTN14480620_PIS_V6_06Feb24.pdf |
| Scientific title | STTAMP - Sleep Tracking & Treatment for Adolescent Mental Health |
| Study acronym | STTAMP |
| Study objectives | To create and evaluate an online support programme (STTAMP) that will use children and young people’s (CYP) smartphones to detect and treat early onset sleep problems and early mental health problems. Most CYP with mental health problems don’t get the help they need. Sleep problems (also called insomnia symptoms) can be both a cause and a consequence of mental health problems. Insomnia symptoms are very common when CYP are becoming anxious, depressed or even suicidal. The University of Bristol have developed an app (Sleep Tracker) that detects when insomnia symptoms start. We want to combine this with treatment using CYP’s smart phones in a programme called STTAMP. We need to make sure CYP (including those from poorer backgrounds and different cultural backgrounds) will use STTAMP. |
| Ethics approval(s) |
Approved 26/07/2024, North West - Greater Manchester Central Research Ethics Committee (2 Redman Place, Stratford, London, E20 1JQ, United Kingdom; None provided; gmcentral.rec@hra.nhs.uk), ref: 23/NW/0129 |
| Health condition(s) or problem(s) studied | Early detection of insomnia and mental health problems in 14 to 18-year-olds and a program of treatment thereafter. |
| Intervention | Participants will download an app which will monitor their sleep for 6 weeks. Those found to have early signs of insomnia will be offered three interventions: 1. Advice in the form of engaging audio/visual modules 2. An adapted teen version of the effective adult SHUTi program 3. Effective automated online and signposting to NHS treatment. All participants will be asked to complete 6 and 12 month questionnaires and some participants will be interviewed to discover their experiences of the study. Participants will take part in the study for 1 year and the total duration of follow-up is expected to be 29 months. |
| Intervention type | Behavioural |
| Primary outcome measure | 1. For participants aged 14-18 at the time of 6 and 12 month follow-up, the Revised Children’s Anxiety and Depression Scale (RCADS) will be used to measure anxiety and depression symptoms at 6 and 12 months 2. For participants aged over 18 at the time of 6 and 12 month follow-up, the Patient Health Questionnaire (PHQ) and General Anxiety Disorder Questionnaire (GAD) score will be used to measure anxiety and depression symptoms at 6 and 12 months 3. Assessment of long term impact of STTAMP will be measured using linkage to NHS Digital data and the Nation Pupil Database/Longitudinal Education Outcomes Database (NPD/LEO) through the ONS Secure Research Service. Educational attendance/attainment, economic productivity and access to NHS services, benefits and mental health services will be assessed at approximately 5 years. |
| Secondary outcome measures | There are no secondary outcome measures |
| Overall study start date | 01/07/2022 |
| Completion date | 31/01/2026 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Child |
| Lower age limit | 14 Years |
| Upper age limit | 18 Years |
| Sex | Both |
| Target number of participants | 1000 |
| Total final enrolment | 1048 |
| Key inclusion criteria | 1. Aged 14-18 years 2. Attend secondary school or college 3. Have an Android mobile phone 4. Have received adequate information about the study and understand they can withdraw from the study at any time |
| Key exclusion criteria | 1. Aged 14 or 15 years and do not have the consent of their parent/carer. 2. Ae receiving clinical treatment for their insomnia and/or mental health difficulties. |
| Date of first enrolment | 01/09/2023 |
| Date of final enrolment | 04/03/2025 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
University of Bristol
Canynge Hall
Third Floor
39 Whatley Road
Bristol
BS8 2PS
United Kingdom
Sponsor information
University/education
Research Governance Team
Research & Enterprise Division
University of Bristol
Augustine Courtyard
Orchard Lane
Bristol
BS1 5DD
England
United Kingdom
| Phone | +44 117 4553343 |
|---|---|
| research-governance@bristol.ac.uk | |
| Website | http://bristol.ac.uk/ |
"ROR" |
https://ror.org/0524sp257 |
Funders
Funder type
University/education
Government organisation / Universities (academic only)
- Alternative name(s)
- Universitas Bristolliensis, bristoluniversity, bristoluni
- Location
- United Kingdom
No information available
Results and Publications
| Intention to publish date | 31/01/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in non-publicly available repository |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be stored in a non-publicly available repository (A secure server at the University of Bristol). Participant details, study data and data obtained from NHS Digital and the Nation Pupil Database/Longitudinal Education Outcomes Database will be stored in strict accordance with data protection rules and regulations on secure University of Bristol servers with only authorised users given access. The data will for stored for two years after the final participant has been recruited. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version 6 | 06/02/2024 | 21/05/2024 | No | Yes |
| Participant information sheet | Parent/carer version 6 |
07/02/2024 | 21/05/2024 | No | Yes |
| Protocol file | version 6 | 20/02/2024 | 21/05/2024 | No | No |
| Protocol file | version 7 | 14/06/2024 | 03/03/2025 | No | No |
Additional files
Editorial Notes
15/04/2025: The following changes were made:
1. The recruitment end date was changed from 30/04/2025 to 04/03/2025.
2. The total final enrolment was added.
03/03/2025: Protocol version 7 uploaded.
31/01/2025: The following changes were made:
1. The recruitment end date was changed from 31/12/2024 to 30/04/2025.
2. The overall study end date was changed from 30/06/2025 to 31/01/2026.
3. The intention to publish date was changed from 30/06/2026 to 31/01/2026.
4. The study website was added.
23/05/2024: The recruitment end date was changed from 31/01/2024 to 31/12/2024.
21/05/2024: Protocol and participant information sheets added.
03/04/2024: The following changes have been made:
1. Ethics approval added.
2. The recruitment start date was changed from 01/04/2023 to 01/09/2023.
3. The recruitment end date was changed from 01/03/2024 to 31/01/2024.
4. IRAS number added.
09/02/2023: The recruitment start date was changed from 01/02/2023 to 01/04/2023.
16/11/2022: Trial's existence confirmed by Prudence trust
