Acceptability and Feasibility of a Brief Paranoia Intervention.

NCT07350954 | Recruiting

• 1 other identifier: RoyalHollowayTRUST
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Paranoia

Keywords

Paranoia; Adolescents; Child and Adolescent Mental Health Service; Feasibility; Acceptability; Mental Health

Outcome Measures

Primary Outcomes (4)

• 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.

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

• 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

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

• 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

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

• 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.

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

Secondary Outcomes (5)

• Paranoia - Revised Green et al., Paranoid Thoughts Scale (R-GPTS) Part B

  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)

  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)

  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).

  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)

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

Study Arms (1)

TRUST

EXPERIMENTAL

A six-session individual psychological intervention combining values-based and mental imagery techniques for adolescents experiencing paranoia.

Behavioral: TRUST

Interventions

TRUST BEHAVIORAL

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.

TRUST

Eligibility Criteria

• Age: 16 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• Lucy Jonas: lead

Study Sites (1)

Westminster's Child and Adolescent Mental Health Service

London, W9 2NW, United Kingdom

RECRUITING

Related Publications (10)

• 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 BACKGROUND

• 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

  BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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.

  PMID: 31744588 BACKGROUND

• 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.

  PMID: 32264985 BACKGROUND

MeSH Terms

Conditions

Paranoid Disorders; Psychological Well-Being

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Personal Satisfaction; Behavior

Central Study Contacts

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief Investigator

Study Record Dates

• First Submitted: December 8, 2025
• First Posted: January 20, 2026
• Study Start: October 24, 2025
• Primary Completion: April 1, 2026
• Study Completion: May 1, 2026
• Last Updated: January 20, 2026

Record last verified: 2025-12

Locations

GB (1)