Clinical trial NCT03160092: The Feasibility of a Novel Intervention for At Risk Mental State
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: At Risk Mental State
Attenuated Psychotic Symptoms
Lead sponsor: University of East Anglia
Sponsor class: OTHER
Collaborators: name: Norfolk and Suffolk NHS Foundation Trust
First posted: 2017-05-19
Enrollment: 12
Sex: ALL
Minimum age (years): 16
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Comprehensive Assessment of At Risk Mental State (CAARMS) - Change in At Risk Symptoms
timeFrame: 2 months
Secondary outcomes:
measure: Clinical Outcomes in Routine Evaluation Outcome Measure (CORE-OM) - Change in psychological wellbeing
timeFrame: 2 months
measure: Revised Short Version of the Working Alliance Inventory (WAI-SR)
timeFrame: 2 months
measure: Session Rating Scale (SRS) - Completed after each session
timeFrame: 1 week
Other outcomes:
measure: Service User Participant Experience Questionnaire
timeFrame: 2 months
measure: Interventional Therapist Participant Experience Questionnaire
timeFrame: 2 months
measure: Youth Team Clinicians Participant Experience Questionnaire
timeFrame: 2 months
Locations:
city: Norwich
country: United Kingdom
facility: Central Norfolk Youth Team, 80 St Stephens Road
state: Norfolk
Study officials:
References: