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Enrolling by invitation NCT06975228

TReating Unhelpful Suspicious Thoughts in Adolescents (TRUST): a School-based Case Series

No phase Interventional Paranoia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: TRUST.
Who it may be relevant to
Registry conditions: Paranoia. Basic parameters: 16 years — 19 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United Kingdom
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

The goal of this acceptability and feasibility trial is to identify whether a six-session intervention for suspicious thoughts is feasible and acceptable to school-based adolescents. The main research question is: Is it feasible and acceptable to offer a brief imagery and values-based intervention for adolescents experiencing paranoia in schools? Aims The primary aim of the current study is to identify whether a six-session brief intervention delivered in schools is feasible and acceptable to young people experiencing paranoia. Secondarily, it aims to identify preliminary outcomes of such an intervention on levels of paranoia, as measured by the Revised Green et al., Paranoid Thoughts Scale (R-GPTS). Participants will be screened for paranoid thoughts and those eligible will be offered a six-session intervention. Participants will be asked to complete various measures prior to and following therapy.

Interventions

  • Behavioral TRUST
    Six-session psychological intervention focussing on values and imagery Session 1: Assessment, formulation and psychoeducation Session 2: Values and values-based goals Session 3-5: Harnessing imagery to pursue values and imagery focussed strategies to change negative beliefs about self and others Session 6: Review

Primary outcome measures

  • Recruitment [Time frame: Throughout course of study - 18 months]
  • Retention [Time frame: Throughout course of study - 18 months]
  • Adherance [Time frame: Throughout course of study - 18 months]
  • Acceptability [Time frame: End of patient involvement]
Secondary outcome measures (6)
  • Revised Green et al., Paranoid Thoughts Scale (R-GPTS) Part B [Time frame: Weekly sessions]
  • Comprehensive Assessment of Acceptance and Commitment Therapy processes for Youth (compACT-Y; Morey et al., 2024) [Time frame: Baseline assessment, post-therapy (following six sessions), 6 week follow-up]
  • Negative mental imagery questionnaire (MIQ-N) [Time frame: Baseline assessment, post-therapy (following six sessions), 6 week follow-up]
  • Brief Core Schema Scale (BCSS) [Time frame: Baseline assessment, post-therapy (following six sessions), 6 week follow-up]
  • Work and Social Adjustment Scale - Youth (WSAS-Y) [Time frame: Baseline assessment, post-therapy (following six sessions), 6 week follow-up]
  • Imagery characteristics [Time frame: Baseline assessment, post-therapy (following six sessions), 6 week follow-up]

Eligibility criteria

Inclusion criteria

  • Age 16+
  • Attending participating school
  • Low risk
  • No current mental health support
  • Symptoms of paranoia i.e. scoring above 11 on R-GPTS part B subscales, equating to "moderately severe" paranoia and above

Exclusion criteria

  • evidence of a primary alcohol or substance dependence issue at initial assessment;
  • developmental disability;
  • not fluent in English (due to questionnaire validity issues);
  • receiving another therapy at the same time;
  • moderate to high levels of risk

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
  • Hanson School — Bradford

Identifiers

NCT: NCT06975228 · 191567

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗