Acceptability and Feasibility of a Brief Paranoia Intervention.

Official title

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

Overview

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? 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.

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.

Interventions

• Behavioral TRUST
  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 imager

Primary outcome measures

• Recruitment [Time frame: From screening to completion of recruitment (up to 6 months)]
• Retention [Time frame: From enrolment to one-month follow-up (up to 14 weeks)]
• Adherence [Time frame: From first therapy session to final therapy session (up to 6 weeks).]
• Acceptability [Time frame: Throughout the study, at the end of therapy, and at one month follow up (up to 14 weeks)]

Secondary outcome measures (5)

• Paranoia - Revised Green et al., Paranoid Thoughts Scale (R-GPTS) Part B [Time frame: Screening, before intervention (baseline), weekly baseline, each therapy session (weeks 1-6) and at one-month follow-up (up to 14 weeks).]
• Negative Self and Other Beliefs - The Brief Core Schema Scales (BCSS) [Time frame: Before intervention (baseline), after intervention (session 6; 6 weeks), and at one-month follow-up.]
• Mental Imagery Characteristics - The Negative Mental Imagery Questionnaire (MIQ-N) [Time frame: Before intervention (baseline), after intervention (session 6; 6 weeks), and at one-month follow-up.]
• Values - Comprehensive Assessment of Acceptance and Commitment Therapy processes for Youth (compACT-Y; Morey et al., 2024). [Time frame: Before intervention (baseline), after intervention (session 6; 6 weeks), and at one-month follow-up.]
• Functioning - Work and Social Adjustment Scale for Youth (WSAS-Y) [Time frame: Before intervention (baseline), after intervention (session 6; 6 weeks), and at one-month follow-up.]

Eligibility criteria

Inclusion criteria

• 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).

Exclusion criteria

• 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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Other

Study locations

United Kingdom · 1 center

• Westminster's Child and Adolescent Mental Health Service — London

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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 32006302

Identifiers

NCT: NCT07350954 · RoyalHollowayTRUST

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗