AzTrials
AzTrials

ParanoiaTRUSTNCT07350954

Acceptability and Feasibility of a Brief Paranoia Intervention.

A study testing TRUST in people with Paranoia, run by Lucy Jonas at 1 site in United Kingdom.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

The goal of this feasibility and acceptability trial is to test whether a new brief talking therapy can be successfully provided to and is suitable for adolescents (16-18) who are seeking help from Child and Adolescent Mental Health Services (CAMHS). Read more about this study

Who is it for?
Ages 16 to 18 years
Conditions the study is for
Paranoia
What is being tested?
TRUST
Could I receive a placebo?
No, everyone receives an active treatment
How many people
8 participants
Where
1 siteUnited Kingdom
Study dates
24 Oct 2025to May 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Aged 16-18
  • Seeking help from a Child and Adolescent Mental Health Service (CAMHS)
  • A score ≥ 11 on the R-GPTS (Scale B)
  • Sufficient understanding of English
  • Capacity to consent, as assessed during the initial interview
  • Wanting support with paranoia
  • Low- moderate mental health risks (emotional difficulties that impact functioning, but no immediate risk to safety e.g., no suicidal intent).

Who cannot join

  • Severe comorbid diagnoses apparent at the initial assessment (e.g., a primary alcohol or substance dependence issue measured using standardised assessments)
  • The presence of a developmental disability or cognitive impairment that would interfere with participation.
  • Concurrent participation in another psychological therapy
  • High levels of current risk (e.g., significant and immediate concerns about the young person's safety, such as suicidal intent).

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Jessica Kingston, DClinPsy PhD contact

+44 1784 414105

jessica.kingston@rhul.ac.uk

Christopher Taylor, DClinPsy PhD contact

chris.d.j.taylor@sheffield.ac.uk

United Kingdom1 site, 1 recruiting
  • Westminster's Child and Adolescent Mental Health Service

    London, W9 2NW

    Jennifer Wauchope, 0203 317 5999, j.wauchope@nhs.net

    Jennifer Wauchope

    Recruiting

Other trials in United Kingdom

About this study

Official title: Assessing the Acceptability and Feasibility of TRUST, a Brief Intervention for Paranoia in Adolescents.

The goal of this feasibility and acceptability trial is to test whether a new brief talking therapy can be successfully provided to and is suitable for adolescents (16-18) who are seeking help from Child and Adolescent Mental Health Services (CAMHS).

The main research question for the current study is: Is it feasible and acceptable to offer a brief values-based (helping young people identify what matters most to them) and imagery (using imagination to visualise positive experiences) intervention for adolescents experiencing paranoia in CAMHS?

Read more

It also aims to identify preliminary clinical outcomes, particularly changes in paranoia severity as measured by the Revised Green et al., Paranoid Thoughts Scale (R-GPTS).

Participants will complete an eligibility assessment and those eligible will be offered a six-session intervention. Assessment measures will be completed before, during and after the intervention.

Read the detailed description

Paranoia involves intense fears that others intend to cause harm. This fear of being under threat and unable to trust others often causes a young person significant distress and impairs everyday functioning. Paranoia is common in adolescence (20-30% report weekly fears, rising to 35% among those seeking mental health care), occurring not only in psychosis but across a range of mental health disorders. Help-seeking adolescents with various non-psychotic conditions commonly report paranoid thoughts. Despite the prevalence and impact, there are currently no proven therapies designed specifically for young people experiencing paranoia. This trial aims to address this gap.

Current treatments for paranoia focus almost exclusively on adults. In adult populations, values-based approaches and mental imagery techniques have shown promise in reducing paranoia. These interventions address underlying cognitive processes, negative beliefs about self and others, distressing mental images, and lack of values-directed behaviour, which maintain paranoid thinking. However, youth mental health interventions require developmentally appropriate approaches.

This study's primary aim is to evaluate the feasibility and acceptability of delivering a brief psychological intervention to adolescents experiencing paranoia. Feasibility will assess whether the intervention can be practically delivered within a CAMHS setting, including recruitment capability, participant retention, and completion of study procedures. Acceptability will examine whether young people find the intervention suitable.

Secondary aims include exploring preliminary clinical outcomes. We will examine changes in paranoia symptoms, self and other beliefs, mental imagery, valued action and day-to-day functioning.

This study employs a single-case experimental design (SCED) with multiple baseline lengths (2, 3 and 4 weeks).

After screening for eligibility and completing pre-intervention questionnaires, participants begin a randomly assigned baseline phase to establish stable symptom measurement. Participants then receive six weekly one-hour individual therapy sessions. Outcome measures are completed throughout the intervention to track changes.

One month post-intervention, participants complete a follow-up assessment with the same outcome measures to evaluate maintenance of treatment effects and provide further feedback on their experience.

This feasibility trial addresses a critical treatment gap for adolescent paranoia. If successful, findings could guide the development of larger definitive trials. Positive findings could contribute to the development of evidence-based interventions for young people experiencing paranoia in routine mental health services.

Conditions
Paranoia
Being tested
TRUST
Keywords
Paranoia, Adolescents, Child and Adolescent Mental Health Service, Feasibility, Acceptability, Mental Health
Medical subject headings
Paranoid Disorders, Psychological Well-Being

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TRUSTBehavioural

    Participants will receive TRUST, a six-session individual psychological intervention designed for adolescents who experience frequent or distressing suspicious thoughts about others. The intervention includes values-based work to identify what matters most to the young person, and mental imagery techniques aimed at modifying distressing beliefs about the self and others.

    Session 1: Assessment, Formulation and Psychoeducation Session 2: Values and value based goals Session 3-5: Harnessing imagery to pursue values and imagery focussed strategies to change negative beliefs about self and others Session 6: Bringing it all together and review.

Study groups in NCT07350954
Study groupRoleWhat they receive
TRUSTExperimentalA six-session individual psychological intervention combining values-based and mental imagery techniques for adolescents experiencing paranoia.
Receives: Behavioral: TRUST

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Recruitment

    Recruitment looks at how many young people can be identified, screened, and enrolled into the study. This will show whether it is practical to recruit young people with paranoia from a CAMHS waiting list.

    GREEN: ≥ 5 participants of target recruited AMBER: 3 to 4 of target recruited RED: ≤ 2 of target recruited.

    Measured: From screening to completion of recruitment (up to 6 months)

  2. Retention

    Retention refers to how many participants stay in the study until the end. We will record how many young people complete all six therapy sessions and complete the end-of-therapy and one-month follow-up questionnaires. This shows whether young people are willing and able to stay involved in the study.

    GREEN: ≥5 participants providing end of therapy assessment outcome data AMBER: 3-4 participants providing end of therapy assessment outcome data RED: ≤2 participants providing end of therapy assessment outcome data

    Measured: From enrolment to one-month follow-up (up to 14 weeks)

  3. Adherence

    Adherence describes how well participants follow the study schedule, including how many therapy sessions they attend.

    GREEN: ≥5 participants attend at least 3 sessions of therapy AMBER: 3-4 participants attend at least 3 sessions of therapy RED: ≤2 participants attend at least 3 sessions of therapy

    Measured: From first therapy session to final therapy session (up to 6 weeks).

  4. Acceptability

    Acceptability looks at how young people experience the intervention and whether they find it suitable and helpful. Acceptability of the therapy will be assessed via questionnaires given to participants upon therapy completion or withdrawal and adverse effects of study participation questionnaire.

    Measured: Throughout the study, at the end of therapy, and at one month follow up (up to 14 weeks)

Secondary outcomes (5)
  1. Paranoia - Revised Green et al., Paranoid Thoughts Scale (R-GPTS) Part B

    To screen for and measure paranoia, the study uses the R-GPTS. This questionnaire has 18 items split into two parts: 8 questions about ideas of reference and 10 questions about persecution (feeling that others intend to harm you). The study uses Part B (persecution subscale). Scores of 11 or higher on the persecution scale indicate clinically significant paranoid thoughts. Higher scores reflect greater difficulties with paranoia.

    Measured: Screening, before intervention (baseline), weekly baseline, each therapy session (weeks 1-6) and at one-month follow-up (up to 14 weeks).

  2. Negative Self and Other Beliefs - The Brief Core Schema Scales (BCSS)

    Research has found that holding more negative views about oneself and others are linked to paranoia. The BCSS (Fowler et al., 2006) is a 24-item self-report measure assessing beliefs about the self and others using rating scale from zero (do not believe this) to four (believe it totally). It has strong internal consistency (α = .79 for positive-self and α = .84 for negative self) in clinical samples. For positive-other and negative-other schemas, the alphas were .88 in clinical samples. The BCSS has been demonstrated to be valid, quick and easy.

    Measured: Before intervention (baseline), after intervention (session 6; 6 weeks), and at one-month follow-up.

  3. Mental Imagery Characteristics - The Negative Mental Imagery Questionnaire (MIQ-N)

    Research has found that distressing mental images play an important role in maintaining paranoia.The MIQ-N measures characteristics of mental imagery. There are 16-items and four sub-scales: intrusiveness, realness, controllability and beliefs.Participants rate how true each of the statements is for them on a seven-point scale. Higher scores mean that these images are more frequent and distressing. The subscales show strong reliability (α= 0.84-0.90),

    Measured: Before intervention (baseline), after intervention (session 6; 6 weeks), and at one-month follow-up.

  4. Values - Comprehensive Assessment of Acceptance and Commitment Therapy processes for Youth (compACT-Y; Morey et al., 2024).

    Research has found that living in line with personal values may help reduce distress associated with paranoia. This study uses the 7 values-based questions from the compACT-Y. These items ask how much they feel able to act in ways that matter to them and live in line with their personal values. Participants rate each statement on a 7-point scale from 0 (not at all true) to 6 (completely true). Higher scores indicate greater engagement in valued action. This has been identified as a valid and reliable measure for young people.

    Measured: Before intervention (baseline), after intervention (session 6; 6 weeks), and at one-month follow-up.

  5. Functioning - Work and Social Adjustment Scale for Youth (WSAS-Y)

    Research has shown that paranoia can impact an adolescent's ability to engage in everyday activities. The WSAS-Y is a five-item self-report measure that evaluates functional impairment across key life domains including work/school and relationships with family/friends. Severity is assessed using an nine-point scale, with greater scores indicating greater impairment. The WSAS-Y has demonstrated good psychometric properties (e.g., internal consistency: α = 0.84) and is developmentally appropriate for adolescent populations.

    Measured: Before intervention (baseline), after intervention (session 6; 6 weeks), and at one-month follow-up.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jan 2026
  2. Study start24 Oct 2025
  3. Primary completionApr 2026 (estimated)
  4. Study completionMay 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
8 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07350954
Sponsor's protocol ID
RoyalHollowayTRUST
Acronym
TRUST
Status last verified
Dec 2025
First submitted
8 Dec 2025
Last updated
20 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: We request optional consent to share fully anonymised data with other researchers to support future studies. If consent is not given, or if confidentiality cannot be fully protected, individual participant data will not be shared.

Publications

  • Morey A, Samuel V, Lewis M, Williams M. Validation of the comprehensive assessment of acceptance and commitment therapy processes for youth: The CompACT-Y. JCPP Adv. 2024 Aug 11;5(2):e12271. doi: 10.1002/jcv2.12271. eCollection 2025 Jun.

    PubMed 40519958
  • Parker A, Kingston J. Evaluating a values-based intervention for adolescence with high nonclinical paranoia: A schools-based randomised control trial. Cogn Ther Res. 2022;46:620-8. doi: 10.1007/s10608-021-10278-6

  • Yung AR, McGorry PD, Francey SM, Nelson B, Baker K, Phillips LJ, Berger G, Amminger GP. PACE: a specialised service for young people at risk of psychotic disorders. Med J Aust. 2007 Oct 1;187(S7):S43-6. doi: 10.5694/j.1326-5377.2007.tb01336.x.

    PubMed 17908025
  • Kingston J, Ellett L. Self-affirmation and nonclinical paranoia. J Behav Ther Exp Psychiatry. 2014 Dec;45(4):502-5. doi: 10.1016/j.jbtep.2014.07.004. Epub 2014 Jul 22.

    PubMed 25090449
  • Garety PA, Freeman D. The past and future of delusions research: from the inexplicable to the treatable. Br J Psychiatry. 2013 Nov;203(5):327-33. doi: 10.1192/bjp.bp.113.126953.

    PubMed 24187067
  • van Os J, Reininghaus U. Psychosis as a transdiagnostic and extended phenotype in the general population. World Psychiatry. 2016 Jun;15(2):118-24. doi: 10.1002/wps.20310.

    PubMed 27265696
  • Oaie FE, Bower JL, Steel C. The development of the Negative Mental Imagery Questionnaire (MIQ-N). Behav Cogn Psychother. 2025 Mar;53(1):17-29. doi: 10.1017/S1352465824000304. Epub 2024 Oct 18.

    PubMed 39421888
  • Jassi A, Lenhard F, Krebs G, Gumpert M, Jolstedt M, Andren P, Nord M, Aspvall K, Wahlund T, Volz C, Mataix-Cols D. The Work and Social Adjustment Scale, Youth and Parent Versions: Psychometric Evaluation of a Brief Measure of Functional Impairment in Young People. Child Psychiatry Hum Dev. 2020 Jun;51(3):453-460. doi: 10.1007/s10578-020-00956-z.

    PubMed 32006302
  • Freeman D, Loe BS, Kingdon D, Startup H, Molodynski A, Rosebrock L, Brown P, Sheaves B, Waite F, Bird JC. The revised Green et al., Paranoid Thoughts Scale (R-GPTS): psychometric properties, severity ranges, and clinical cut-offs. Psychol Med. 2021 Jan;51(2):244-253. doi: 10.1017/S0033291719003155. Epub 2019 Nov 20.

    PubMed 31744588
  • Taylor CDJ, Bee PE, Kelly J, Emsley R, Haddock G. iMAgery focused psychological therapy for persecutory delusions in PSychosis (iMAPS): a multiple baseline experimental case series. Behav Cogn Psychother. 2020 Sep;48(5):530-545. doi: 10.1017/S1352465820000168. Epub 2020 Apr 8.

    PubMed 32264985

Questions about this trial

What is this clinical trial studying?

A study testing TRUST in people with Paranoia, run by Lucy Jonas at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 20 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jessica Kingston, DClinPsy PhD (+44 1784 414105, jessica.kingston@rhul.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recruitment (time frame: From screening to completion of recruitment (up to 6 months)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07350954, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in