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The Feasibility of a Novel Intervention for At Risk Mental State

Assessing the Feasibility of a Novel Intervention for Young People With At Risk Mental State and Attenuated Positive Psychotic Symptoms: The Viability of Its Use in the NHS and of a Future Trial

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03160092
Enrollment
12
Registered
2017-05-19
Start date
2017-04-11
Completion date
2018-09-01
Last updated
2017-05-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

At Risk Mental State, Attenuated Psychotic Symptoms

Brief summary

Young people with At Risk Mental State (ARMS) may have changes in their thoughts and the way they see or hear things, which they might find odd and distressing. They may be feeling tense, worried and low in mood and may not feel like socialising. They may also experience difficulties with eating and sleeping. For many people these symptoms might not last for very long, but for a small number of people, they might last longer and could become worse (health professionals call this psychosis). Psychological therapy, which involves talking to a therapist, can help to stop these symptoms from getting worse, stopping psychosis. It can also help to make the symptoms better. Cognitive Behavioural Therapy (CBT) is the treatment that is most recommended to help young people with ARMS. But, this is not always available, can take a long time and is quite expensive. Some research has shown that brief therapy with a therapist who is warm and understanding and helps the young person to make sense of their symptoms, may be as helpful as CBT, and is quicker and cheaper. This study hopes to develop a treatment like this and to offer it to 12 young people, aged between 16 and 25, who are experiencing the symptoms outlined. Participants will be given four treatment sessions, and will be asked to complete some questionnaires. The study aims to see how they find it and whether it seems to help them. It will also ask professionals who work with these young people what they think about the new therapy. This is a feasibility study so the findings will help us to decide whether more research should be done on this treatment and whether it could be offered in the NHS in the future.

Interventions

OTHERIntervention

The intervention aims to: * Support the participant to explore their unusual experiences * Reduce the distress or anxiety participants feel in response to their unusual experiences, through: * Helping them to recognise how common these unusual experience * Supporting them to make sense of their unusual experiences * Supporting them to understand why they may be experiencing these symptoms * Challenging any unhelpful beliefs they hold about their symptoms * Help the participant to recognise the triggers to their unusual experiences * Support the participant to increase their activities and socialisation The intervention is not aiming to 'get rid' of the participant's symptoms, but to reduce their distress in response to them, which may result in improved wellbeing and reduced symptoms.

Sponsors

Norfolk and Suffolk NHS Foundation Trust
CollaboratorOTHER
University of East Anglia
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
16 Years to 25 Years
Healthy volunteers
No

Inclusion criteria

For Service User Participants (Those receiving the intervention) Inclusion Criteria: * 16 - 25 Years Old * Meeting criteria for attenuated psychosis on the Comprehensive Assessment of At Risk Mental State (CAARMS; Yung et al., 2005) * Has an allocated lead care professional within the Central Norfolk Youth Team * Identified by their care-coordinator as having capacity and being appropriate for therapy (including not being deemed at a high risk of being a danger to themselves or others).

Exclusion criteria

* Meeting criteria for psychosis on the CAARMS and/or a previous open referral to an Early Intervention in Psychosis team * Change of psychiatric medication within the previous three months * Currently receiving psychological therapy * Previously had Cognitive Behavioural Therapy for At Risk Mental State

Design outcomes

Primary

MeasureTime frameDescription
Comprehensive Assessment of At Risk Mental State (CAARMS) - Change in At Risk Symptoms2 monthsThis is a 30 minute semi-structured interview, measuring the intensity, duration and frequency of subthreshold psychotic symptoms

Secondary

MeasureTime frameDescription
Clinical Outcomes in Routine Evaluation Outcome Measure (CORE-OM) - Change in psychological wellbeing2 monthsThe CORE-OM measures: Psychological wellbeing, functioning, symptoms and risk
Revised Short Version of the Working Alliance Inventory (WAI-SR)2 monthsBoth clinician and client versions of this measure will be used to assess the therapeutic alliance formed for each participant
Session Rating Scale (SRS) - Completed after each session1 weekUsed to measure the participant's views of each session

Other

MeasureTime frameDescription
Interventional Therapist Participant Experience Questionnaire2 monthsMeasure of the acceptability of the intervention and the study to the clinicians delivering the intervention (to inform the feasibility aspect of the study)
Youth Team Clinicians Participant Experience Questionnaire2 monthsMeasure of the acceptability of the intervention and the study to clinicians working in NHS Youth Teams (to inform the feasibility aspect of the study)
Service User Participant Experience Questionnaire2 monthsMeasure of the acceptability of the intervention and the study to the participants receiving the intervention (to inform the feasibility aspect of the study)

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026