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The Feasibility of a Novel Intervention for At Risk Mental State

Primary Purpose

At Risk Mental State, Attenuated Psychotic Symptoms

Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Intervention
Sponsored by
University of East Anglia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for At Risk Mental State

Eligibility Criteria

16 Years - 25 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Central Norfolk Youth Team, 80 St Stephens RoadRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention

Arm Description

Clinical Participants will receive a 4 session individual intervention, which will be delivered by Assistant Practitioners and Assistant Psychologists (who will have received specific training in the delivering of the intervention). The intervention will target the participant's attenuated positive psychotic symptoms, which will be referred to as: 'unusual' experiences (unless the participant prefers an alternative). The therapist will focus on creating a therapeutic relationship in which the participant experiences them as warm, accepting and empathic. The aim is for the participant to feel listened to and understood. The intervention will focus on taking a normalising and non-catastrophising approach to the individual's unusual experiences. The participants will be provided with psychoeducation to support this aim.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Clinical Outcomes in Routine Evaluation Outcome Measure (CORE-OM) - Change in psychological wellbeing
The CORE-OM measures: Psychological wellbeing, functioning, symptoms and risk
Revised Short Version of the Working Alliance Inventory (WAI-SR)
Both 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 session
Used to measure the participant's views of each session

Full Information

First Posted
May 12, 2017
Last Updated
May 17, 2017
Sponsor
University of East Anglia
Collaborators
Norfolk and Suffolk NHS Foundation Trust
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1. Study Identification

Unique Protocol Identification Number
NCT03160092
Brief Title
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

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Unknown status
Study Start Date
April 11, 2017 (Actual)
Primary Completion Date
November 1, 2017 (Anticipated)
Study Completion Date
September 1, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of East Anglia
Collaborators
Norfolk and Suffolk NHS Foundation Trust

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
At Risk Mental State, Attenuated Psychotic Symptoms

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Clinical Participants will receive a 4 session individual intervention, which will be delivered by Assistant Practitioners and Assistant Psychologists (who will have received specific training in the delivering of the intervention). The intervention will target the participant's attenuated positive psychotic symptoms, which will be referred to as: 'unusual' experiences (unless the participant prefers an alternative). The therapist will focus on creating a therapeutic relationship in which the participant experiences them as warm, accepting and empathic. The aim is for the participant to feel listened to and understood. The intervention will focus on taking a normalising and non-catastrophising approach to the individual's unusual experiences. The participants will be provided with psychoeducation to support this aim.
Intervention Type
Other
Intervention Name(s)
Intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Comprehensive Assessment of At Risk Mental State (CAARMS) - Change in At Risk Symptoms
Description
This is a 30 minute semi-structured interview, measuring the intensity, duration and frequency of subthreshold psychotic symptoms
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Clinical Outcomes in Routine Evaluation Outcome Measure (CORE-OM) - Change in psychological wellbeing
Description
The CORE-OM measures: Psychological wellbeing, functioning, symptoms and risk
Time Frame
2 months
Title
Revised Short Version of the Working Alliance Inventory (WAI-SR)
Description
Both clinician and client versions of this measure will be used to assess the therapeutic alliance formed for each participant
Time Frame
2 months
Title
Session Rating Scale (SRS) - Completed after each session
Description
Used to measure the participant's views of each session
Time Frame
1 week
Other Pre-specified Outcome Measures:
Title
Service User Participant Experience Questionnaire
Description
Measure of the acceptability of the intervention and the study to the participants receiving the intervention (to inform the feasibility aspect of the study)
Time Frame
2 months
Title
Interventional Therapist Participant Experience Questionnaire
Description
Measure of the acceptability of the intervention and the study to the clinicians delivering the intervention (to inform the feasibility aspect of the study)
Time Frame
2 months
Title
Youth Team Clinicians Participant Experience Questionnaire
Description
Measure of the acceptability of the intervention and the study to clinicians working in NHS Youth Teams (to inform the feasibility aspect of the study)
Time Frame
2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Central Norfolk Youth Team, 80 St Stephens Road
City
Norwich
State/Province
Norfolk
ZIP/Postal Code
NR1 3RE
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emma Burton, MSc
Phone
00000000000
Email
emma.burton@uea.ac.uk

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

The Feasibility of a Novel Intervention for At Risk Mental State

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