Acceptability and Feasibility of a Brief Paranoia Intervention. (TRUST)

January 10, 2026 updated by: Lucy Jonas

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?

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

8

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United Kingdom
      • London, United Kingdom, W9 2NW
        • Recruiting
        • Westminster's Child and Adolescent Mental Health Service
        • Contact:
        • Principal Investigator:
          • Jennifer Wauchope

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TRUST
A six-session individual psychological intervention combining values-based and mental imagery techniques for adolescents experiencing paranoia.
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 imagery to pursue values and imagery focussed strategies to change negative beliefs about self and others Session 6: Bringing it all together and review.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recruitment
Time Frame: From screening to completion of recruitment (up to 6 months)

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

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

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
Time Frame: Throughout the study, at the end of therapy, and at one month follow up (up to 14 weeks)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
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.
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.
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.
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.
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),
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.
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.
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.
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.
Before intervention (baseline), after intervention (session 6; 6 weeks), and at one-month follow-up.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lucy Jonas

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 24, 2025

Primary Completion (Estimated)

April 1, 2026

Study Completion (Estimated)

May 1, 2026

Study Registration Dates

First Submitted

December 8, 2025

First Submitted That Met QC Criteria

January 10, 2026

First Posted (Actual)

January 20, 2026

Study Record Updates

Last Update Posted (Actual)

January 20, 2026

Last Update Submitted That Met QC Criteria

January 10, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RoyalHollowayTRUST

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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