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Enrolling by Invitation

NCT Number: NCT06975228

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

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.

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Key information

Age range

16 year–19 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hanson School

Bradford, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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).

  6. 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'.

Sponsors and collaborators

Lead sponsor

University of Sheffield

Other

Registry information

Acronym: TRUST

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 16, 2025
Registry last updated
May 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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