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

NCT06975228 | Enrolling By Invitation

• 1 other identifier: 191567
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Paranoia

Keywords

Paranoia; Adolescents; School; Feasibility; Acceptability

Outcome Measures

Primary Outcomes (4)

• Recruitment

  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

  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

  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

  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 Outcomes (6)

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

  Weekly sessions

• Comprehensive Assessment of Acceptance and Commitment Therapy processes for Youth (compACT-Y; Morey et al., 2024)

  Baseline assessment, post-therapy (following six sessions), 6 week follow-up

• Negative mental imagery questionnaire (MIQ-N)

  Baseline assessment, post-therapy (following six sessions), 6 week follow-up

• Brief Core Schema Scale (BCSS)

  Baseline assessment, post-therapy (following six sessions), 6 week follow-up

• Work and Social Adjustment Scale - Youth (WSAS-Y)

  Baseline assessment, post-therapy (following six sessions), 6 week follow-up

Study Arms (1)

TRUST

EXPERIMENTAL

Six session psychological intervention focussing on imagery and values

Behavioral: TRUST

Interventions

TRUST BEHAVIORAL

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

TRUST

Eligibility Criteria

• Age: 16 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Sheffield: lead

Study Sites (1)

Hanson School

Bradford, United Kingdom

Location

MeSH Terms

Conditions

Paranoid Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Design

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

Study Record Dates

• First Submitted: April 28, 2025
• First Posted: May 16, 2025
• Study Start: May 2, 2025
• Primary Completion: April 1, 2026
• Study Completion: May 1, 2026
• Last Updated: May 16, 2025

Record last verified: 2025-04

Locations

GB (1)