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

May 7, 2025 updated by: University of Sheffield

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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 Locations

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:

  • 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

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
Six session psychological intervention focussing on imagery and values
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recruitment
Time Frame: Throughout course of study - 18 months
GREEN: > 5 participants of target recruited AMBER = 3 to 4 of target recruited RED < 2 of target recruited
Throughout course of study - 18 months
Retention
Time Frame: Throughout course of study - 18 months
GREEN: 5 or more of participants providing end of therapy assessment outcome data AMBER: 3 to 4 participants providing end of therapy assessment outcome data RED: 2 or less of participants providing end of therapy assessment outcome data
Throughout course of study - 18 months
Adherance
Time Frame: Throughout course of study - 18 months
GREEN= 5 or more participants attend at least 3 sessions of therapy AMBER>= 3 to 4 participants attend at least 3 sessions of therapy RED: 2 or less of participants attend at least 3 sessions of therapy
Throughout course of study - 18 months
Acceptability
Time Frame: End of patient involvement
Acceptability of the therapy will be assessed via therapy process feedback questionnaire given to participants upon therapy completion or withdrawal and adverse effects of study participation questionnaire.
End of patient involvement

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Revised Green et al., Paranoid Thoughts Scale (R-GPTS) Part B
Time Frame: Weekly sessions
For screening of and assessing adolescents' paranoia, Revised Green et al., Paranoid Thoughts Scale (R-GPTS) will be used due to high reliability. The R-GPTS comprises of two subscales assessing for frequency of ideas of references (eight questions) and ideas of persecution (10 questions) on a five-point Likert scale. Part B will be used. "The R-GPTS score ranges are: average (Reference: 0-9; Persecution: 0-4); elevated (Reference: 10-15; Persecution: 5-10); moderately severe (Reference: 16-20; Persecution:11-17); severe (Reference: 21-24; Persecution: 18-27); and very severe (Reference: 25+; Persecution: 28+)". Clinical cut-offs on the persecution scales are 11 for persecutory ideation. Higher levels of RGPTs scores indicate higher difficulties.
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
The compACT-Y consists of 19-items scored on a six-point likert scale to assess psychological flexibility, with higher scores indicating higher flexibility. This includes the three factors of valued action, openness to experience and behavioural awareness, all linking to acceptance and commitment therapy (ACT) frameworks and methodology. This has been identified to be a valid and reliable measure for the use in young people.
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
The MIQ-N consists of 16-items assessing for experiences of mental images. It has four sub-scales: intrusiveness, realness, controllability and beliefs about mental imagery. Participants are asked to rate how true each of the statements are to them on a seven-point Likert scale. Cronbach's alpha ranges from 0.84 - 0.90 when each of the subscales have been tested for reliability. The higher the score the higher the experience of negative mental images.
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
The BCSS evaluates self and other beliefs using a 24-item scale, rating positive and negative self and other beliefs. Participants are asked to initially rate whether they hold the belief on yes/no and then rate the strength of the belief using a four-point Likert scale. Negative evaluations of self and others are suggested to be indicative of paranoia in the general population. The measure has good internal consistency for non-clinical samples (α = 0.74) and good retest-reliability for all subscales.
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
The WSAS-Y is a measure of functionality for young people in areas such as school, relationships and activities. It has five subscales and assesses severity of impairment using an eight-point scale, generating a total score out of 40, with greater scores indicating greater impairment. It has been suggested to have high internal consistency (α = 0.84) and reliability (r = 0.80).
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
The weekly imagery characteristics scale is a seven-item measure rating the characteristics of mental images including how real or pre-occupying they are. Participants are asked to rate each item on a 10-point scale from 'not at all' to 'extremely'.
Baseline assessment, post-therapy (following six sessions), 6 week follow-up

Collaborators and Investigators

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

Sponsor

University of Sheffield

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)

May 2, 2025

Primary Completion (Estimated)

April 1, 2026

Study Completion (Estimated)

May 1, 2026

Study Registration Dates

First Submitted

April 28, 2025

First Submitted That Met QC Criteria

May 7, 2025

First Posted (Actual)

May 16, 2025

Study Record Updates

Last Update Posted (Actual)

May 16, 2025

Last Update Submitted That Met QC Criteria

May 7, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 191567

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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