ParanoiaTRUSTNCT06975228
TReating Unhelpful Suspicious Thoughts in Adolescents (TRUST): a School-based Case Series
A study testing TRUST in people with Paranoia, run by University of Sheffield at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 19 years
- Conditions the study is for
- Paranoia
- What is being tested?
- TRUST
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 2 May 2025to May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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:
Read more
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
- Being tested
- TRUST
- Keywords
- Paranoia, Adolescents, School, Feasibility, Acceptability
- Medical subject headings
- Paranoid Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TRUSTBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| TRUST | Experimental | Six session psychological intervention focussing on imagery and values Receives: Behavioral: TRUST |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment
GREEN: > 5 participants of target recruited AMBER = 3 to 4 of target recruited RED < 2 of target recruited
Measured: 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
Measured: 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
Measured: 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.
Measured: End of patient involvement
Secondary outcomes (6)
Revised Green et al., Paranoid Thoughts Scale (R-GPTS) Part B
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.
Measured: Weekly sessions
Comprehensive Assessment of Acceptance and Commitment Therapy processes for Youth (compACT-Y; Morey et al., 2024)
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.
Measured: Baseline assessment, post-therapy (following six sessions), 6 week follow-up
Negative mental imagery questionnaire (MIQ-N)
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.
Measured: Baseline assessment, post-therapy (following six sessions), 6 week follow-up
Brief Core Schema Scale (BCSS)
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.
Measured: Baseline assessment, post-therapy (following six sessions), 6 week follow-up
Work and Social Adjustment Scale - Youth (WSAS-Y)
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).
Measured: Baseline assessment, post-therapy (following six sessions), 6 week follow-up
Imagery characteristics
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'.
Measured: Baseline assessment, post-therapy (following six sessions), 6 week follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2025
- Study start2 May 2025
- Primary completionApr 2026 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ParanoiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sheffield
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06975228
- Sponsor's protocol ID
- 191567
- Acronym
- TRUST
- Status last verified
- Apr 2025
- First submitted
- 28 Apr 2025
- Last updated
- 16 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TReating Unhelpful Suspicious Thoughts in Adolescents (TRUST): a School-based Case Series
- ClinicalTrials.gov ID
- NCT06975228
- Acronym / sponsor ID
- TRUST / 191567
- Conditions
- Paranoia
- Keywords
- Paranoia, Adolescents, School, Feasibility, Acceptability
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- University of SheffieldUniversity, hospital or other
- Study start
- 2 May 2025 (actual)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 16 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TRUST | Experimental | Behavioral: TRUSTSix session psychological intervention focussing on imagery and values |
Who may qualify
- Ages
- 16 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TRUSTSix-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 | Behavioural | TRUST |
Primary outcome
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
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
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
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.
6 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TRUST in people with Paranoia, run by University of Sheffield at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 16 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment (time frame: Throughout course of study - 18 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2025; AzTrials last refreshed its copy on 3 Nov 2026.