Treating unhelpful suspicious thoughts in teenagers
| ISRCTN | ISRCTN67596256 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN67596256 |
| Integrated Research Application System (IRAS) | 349714 |
| Central Portfolio Management System (CPMS) | 64892 |
| National Institute for Health and Care Research (NIHR) | 208711 |
| Sponsor | Pennine Care NHS Foundation Trust |
| Funder | National Institute for Health and Care Research |
- Submission date
- 30/01/2026
- Registration date
- 19/03/2026
- Last edited
- 19/03/2026
- Recruitment status
- Not yet recruiting
- Overall study status
- Ongoing
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study sims
Paranoia, exaggerated fears that others intend to cause one harm, is common in adolescents. It has been found that 20-30% of school-attending adolescents reported weekly paranoid beliefs. Rates were significantly higher in adolescents seeking psychological support from Child and Adolescent Mental Health Services (CAMHS), with paranoia persisting or worsening, over 3-months, in 75% of cases. In a recent UK-wide adolescent sample, using a more psychometrically validated measure of paranoia, 27% reported clinically meaningful levels of paranoia.
Adolescents report that paranoia is distressing and negatively impacts their lives. It has a significant negative effect socially, personally, on education and prospectively on self-esteem and well-being. Paranoia is transdiagnostic, occurring alongside numerous mental health symptoms and is one of a small cluster of symptoms that pose a pluripotent risk for multiple future psychiatric disorders. Paranoia is a risk factor for persecutory delusions, the most common symptom of psychosis. Further, research shows that the severity of psychosis is greater when the onset is in adolescence. The annual costs of schizophrenia in England alone are £11.8 billion (National Institute for & Care, 2014) and have accounted for high adolescent inpatient admissions. Reducing CAMHS and Early Intervention referrals could generate substantial NHS savings.
To date, however, there are no treatments targeting paranoia before it reaches a delusional level. School-based NHS Educational Mental Health Practitioners (EMHPs) treat common mental health difficulties (not including paranoia), and NHS early intervention services target psychotic symptoms, including persecutory delusions, but only once the young person’s symptoms meet prodromal/At Risk Mental State (ARMS) and First Episode Psychosis. A current systematic review (https://www.crd.york.ac.uk/PROSPERO/view/CRD42024589239) confirms that there are no early interventions specifically targeting paranoia in adolescents. The paucity of interventions specific to adolescents with paranoia and psychosis more broadly has been recognised by NICE Clinical Guideline CG155, recommending further research focusing on young people with early symptoms (National Institute for Health & Care Excellence, 2014).
Who can participate?
Young people aged 16-18 years at participating schools and/or colleges who experience elevated suspicious thoughts/paranoia.
What does the study involve?
Participants will be randomly allocated to either the TRUST treatment arm or the standard support arm. Those receiving the TRUST intervention will be offered up to six sessions of an integrated imagery and values-based brief psychological therapy.
Process Evaluation - Qualitative aspect of the study:
Participants who are randomised will be invited to take part in up to two qualitative interviews about their experience of the trial and therapy (for those in the therapy arm) at the end of the trial.
What are the possible benefits and risks of participating?
Possible benefits to participation may include feelings of satisfaction and achievement at being involved in trial research that leads to improved psychological therapies for young people living with elevated paranoia. Moreover, individuals receiving the TRUST therapy interventions may also experience improvement in their ability to cope with and manage symptoms of paranoia.
This study does not involve any known physical risks or harm to participants or the researchers. However, talking about personal experiences and feelings may be difficult and can cause emotional upset. The protocol for assessing and reporting risks and the distress protocol for the current study will be followed in such cases.
Where is the study run from?
Pennine Care NHS Foundation Trust (UK)
When is the study starting and how long is it expected to run for?
March 2026 to December 2027.
Who is funding the study?
National Institute for Health and Care Research (NIHR) (UK).
Who is the main contact?
Dr Christopher Taylor (Co-Chief Investigator), chris.d.j.taylor@sheffield.ac.uk
Dr Jessica Kingston (Co-Chief Investigator), jessica.kingston@rhul.ac.uk
Contact information
Public, Scientific, Principal investigator
Co-Chief Investigator
Senior Lecturer, NIHR Fellow and NHS Consultant Clinical Psychologist
School of Psychology
Faculty of Science, The University of Sheffield
ICOSS Building, 219 Portobello
Sheffield
S1 4DP
United Kingdom
 ORCID ID |
0000-0002-1989-883X |
|---|---|
| Phone | +44 0114 222 6533 |
| chrisdjtaylor@nhs.net |
Principal investigator, Public, Scientific
Co-Chief Investigator
Senior Lecturer and Joint Research Director and Clinical Psychologist
Doctorate in Clinical Psychology
Department of Psychology
Royal Holloway, University of London
Egham, Surrey
TW20 0EX
United Kingdom
| ORCID ID |
0000-0002-1142-8083 |
|---|---|
| Phone | +44 01784 414105 |
| jessica.kingston@rhul.ac.uk |
Study information
| Primary study design | Interventional | |
|---|---|---|
| Allocation | Randomized controlled trial | |
| Masking | Blinded (masking used) | |
| Control | Active | |
| Assignment | Parallel | |
| Purpose | Treatment | |
| Scientific title | Treating Unhelpful Suspicious Thoughts in teenagers (TRUST): A school-based feasibility randomised controlled clinical trial for adolescents with elevated paranoia | |
| Study acronym | TRUST | |
| Study objectives | Aim: Assess the feasibility of conducting a school-based RCT on a brief psychological therapy versus standard support to reduce elevated paranoia in adolescents. Primary Objectives: 1. To assess the number of adolescents who are eligible and consent to the trial 2. To investigate the level of engagement with and adherence to the therapy 3. To assess the retention of participants and data completion 4. To assess the safety of the intervention and of running the trial. | |
| Ethics approval(s) |
Submitted 04/02/2026, Wales REC 06 (-, Swansea, -, United Kingdom; +44 02920 230 457/02922 944198; Wales.REC6@wales.nhs.uk), ref: 25/WA/0364 | |
| Health condition(s) or problem(s) studied | Paranoia | |
| Intervention | This study is a multi-school, assessor-blind, parallel-group, feasibility randomised controlled trial (RCT) with a nested mixed-methods process evaluation. It will recruit n=40 participants. The trial will be hosted by secondary schools in England, ideally in Manchester (NW) and London (SW). The two arms for the trial are: a) usual support plus TRUST, the new therapeutic intervention that integrates imagery and values techniques and b) Usual Support, which includes any psychological support the young person uses during the trial period. Participants are assigned a 1:1 allocation ratio, with 50:50 stratified across site (London and Manchester). Following the baseline visit, eligible and consenting participants will be randomised using a sealed envelope randomisation system. TRUST: An imagery and values-based psychological intervention, consisting of six (45 to 60 minutes) sessions. TRUST is delivered by therapists and will be accompanied by a therapy workbook. The intervention will combine (A) value identification and value-based goal setting with B) imagery protocols to reduce the distress associated with negative images of harm from others and to build value-consistent imagery to support valued action. Usual support can also be accessed. Control: Usual support will include all support that the young person accesses, inside and outside of school, during the study period. | |
| Intervention type | Other | |
| Primary outcome measure(s) |
| |
| Key secondary outcome measure(s) | ||
| Completion date | 31/12/2027 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Mixed |
| Lower age limit | 16 Years |
| Upper age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 40 |
| Key inclusion criteria | Selection of schools A school will be included if: 1. It is a mainstream school located in London, Greater Manchester, or the surrounding areas in the South and North of England. 2. They are able to provide a named link person for risk and safeguarding liaison within the school, and a room for therapy sessions Inclusion criteria: 1. Aged 16 to 18 years 2. Attends a school /college or sixth form/recruiting to TRUST. 3. Able to provide written informed consent. 4. Able to engage in psychological assessments and the intervention 5. At least moderately severe paranoid beliefs, scoring of 11+ on the R-GPTS Ideas of Persecution subscale, indicating at least moderately elevated paranoia (Freeman et al., 2019). 6. Young person would like support to reduce paranoid fears. Qualitative study: Adolescents participating in the trial will be invited to consent to a qualitative interview at the point of consenting to the trial itself. This increases the chances that we will have consent from those completing therapy as well as those who drop out. |
| Key exclusion criteria | 1. Primary alcohol/substance dependence issue at initial assessment (primary dependence to be treated elsewhere first and adolescents can be re-referred to participate). Issues will be initially probed using the AUDIT and the DAST and further assessed, if indicated, via assessment questioning. 2. Developmental learning disability or significant head injury, neurological disorder or epilepsy. This will be stated in the participant information sheet and the participant will be asked at first assessment whether they have been given a diagnosis and by whom. 3. Moderate to high levels of risk, assessed at initial interview (see below). 4. Current diagnosis of bipolar disorder, post-traumatic stress disorder (PTSD) or psychosis and/or current or previous receipt of antipsychotic medication for more than 2 days (which would suggest already having made a transition to a first episode of psychosis). This will be stated in the participant information sheet and the participant will be asked at first assessment whether they have been given a diagnosis and by whom. 5. Other significant conditions or factors that contraindicate the young person’s participation in the trial. These will be assessed by asking the adolescent at the screening assessment. Responses will be carefully recorded and reported in the CONSORT, to further operationalise them in a future trial. |
| Date of first enrolment | 23/03/2026 |
| Date of final enrolment | 31/01/2027 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centres
Ashton-under-lyne
OL6 7SR
England
350 Euston Road
Regents PLACE
London
NW1 3AX
England
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | At the discretion of the Co-Chief Investigators (chris.d.j.taylor@sheffield.ac.uk and jessica.kingston@rhul.ac.uk) and team, anonymised data will be made available upon reasonable request, which must include a protocol and statistical analysis plan and not be in conflict with the research team’s planned publication strategy, and after we have completed our publication strategy, consistent with our data sharing policy. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Other publications | 11/09/2024 | 19/03/2026 | Yes | No |
Editorial Notes
30/01/2026: Study's existence confirmed by the National Institute for Health and Care Research (NIHR) (UK).
