About this trial
The goal of this feasibility and acceptability trial is to test whether a new brief talking therapy can be successfully provided to and is suitable for adolescents (16-18) who are seeking help from Child and Adolescent Mental Health Services (CAMHS).
The main research question for the current study is: Is it feasible and acceptable to offer a brief values-based (helping young people identify what matters most to them) and imagery (using imagination to visualise positive experiences) intervention for adolescents experiencing paranoia in CAMHS?
It also aims to identify preliminary clinical outcomes, particularly changes in paranoia severity as measured by the Revised Green et al., Paranoid Thoughts Scale (R-GPTS).
Participants will complete an eligibility assessment and those eligible will be offered a six-session intervention. Assessment measures will be completed before, during and after the intervention.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Aged 16-18
Seeking help from a Child and Adolescent Mental Health Service (CAMHS)
A score ≥ 11 on the R-GPTS (Scale B)
Sufficient understanding of English
Disqualifiers
Severe comorbid diagnoses apparent at the initial assessment (e.g., a primary alcohol or substance dependence issue measured using standardised assessments)
The presence of a developmental disability or cognitive impairment that would interfere with participation.
Concurrent participation in another psychological therapy
High levels of current risk (e.g., significant and immediate concerns about the young person's safety, such as suicidal intent).
Trial design
Single group
Treatments tested in this trial
TRUST
BehavioralParticipants will receive TRUST, a six-session individual psychological intervention designed for adolescents who experience frequent or distressing suspicious thoughts about others. The intervention includes values-based work to identify what matters most to the young person, and mental imagery techniques aimed at modifying distressing beliefs about the self and others. Session 1: Assessment, Formulation and Psychoeducation Session 2: Values and value based goals Session 3-5: Harnessing imagery to pursue values and imagery focussed strategies to change negative beliefs about self and others Session 6: Bringing it all together and review.
Treatment groups
Trial outcomes
Primary outcomes
Recruitment
Recruitment looks at how many young people can be identified, screened, and enrolled into the study. This will show whether it is practical to recruit young people with paranoia from a CAMHS waiting list. GREEN: ≥ 5 participants of target recruited AMBER: 3 to 4 of target recruited RED: ≤ 2 of target recruited.
Retention
Retention refers to how many participants stay in the study until the end. We will record how many young people complete all six therapy sessions and complete the end-of-therapy and one-month follow-up questionnaires. This shows whether young people are willing and able to stay involved in the study. GREEN: ≥5 participants providing end of therapy assessment outcome data AMBER: 3-4 participants providing end of therapy assessment outcome data RED: ≤2 participants providing end of therapy assessment outcome data
Adherence
Adherence describes how well participants follow the study schedule, including how many therapy sessions they attend. GREEN: ≥5 participants attend at least 3 sessions of therapy AMBER: 3-4 participants attend at least 3 sessions of therapy RED: ≤2 participants attend at least 3 sessions of therapy
Acceptability
Acceptability looks at how young people experience the intervention and whether they find it suitable and helpful. Acceptability of the therapy will be assessed via questionnaires given to participants upon therapy completion or withdrawal and adverse effects of study participation questionnaire.
Secondary outcomes
Paranoia - Revised Green et al., Paranoid Thoughts Scale (R-GPTS) Part B
To screen for and measure paranoia, the study uses the R-GPTS. This questionnaire has 18 items split into two parts: 8 questions about ideas of reference and 10 questions about persecution (feeling that others intend to harm you). The study uses Part B (persecution subscale). Scores of 11 or higher on the persecution scale indicate clinically significant paranoid thoughts. Higher scores reflect greater difficulties with paranoia.
Negative Self and Other Beliefs - The Brief Core Schema Scales (BCSS)
Research has found that holding more negative views about oneself and others are linked to paranoia. The BCSS (Fowler et al., 2006) is a 24-item self-report measure assessing beliefs about the self and others using rating scale from zero (do not believe this) to four (believe it totally). It has strong internal consistency (α = .79 for positive-self and α = .84 for negative self) in clinical samples. For positive-other and negative-other schemas, the alphas were .88 in clinical samples. The BCSS has been demonstrated to be valid, quick and easy.
Mental Imagery Characteristics - The Negative Mental Imagery Questionnaire (MIQ-N)
Research has found that distressing mental images play an important role in maintaining paranoia.The MIQ-N measures characteristics of mental imagery. There are 16-items and four sub-scales: intrusiveness, realness, controllability and beliefs.Participants rate how true each of the statements is for them on a seven-point scale. Higher scores mean that these images are more frequent and distressing. The subscales show strong reliability (α= 0.84-0.90),
Values - Comprehensive Assessment of Acceptance and Commitment Therapy processes for Youth (compACT-Y; Morey et al., 2024).
Research has found that living in line with personal values may help reduce distress associated with paranoia. This study uses the 7 values-based questions from the compACT-Y. These items ask how much they feel able to act in ways that matter to them and live in line with their personal values. Participants rate each statement on a 7-point scale from 0 (not at all true) to 6 (completely true). Higher scores indicate greater engagement in valued action. This has been identified as a valid and reliable measure for young people.
Sponsors and contacts
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Lucy Jonas
Lead sponsor
Royal Holloway University
Sponsor institution