At Risk Mental StateNCT03160092
The Feasibility of a Novel Intervention for At Risk Mental State
A study testing Intervention in people with At Risk Mental State and Attenuated Psychotic Symptoms, run by University of East Anglia at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 25 years
- Conditions the study is for
- At Risk Mental State, Attenuated Psychotic Symptoms
- What is being tested?
- Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 11 Apr 2017to 1 Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Central Norfolk Youth Team, 80 St Stephens Road
Norwich, Norfolk, NR1 3RE
Emma Burton, MSc, 00000000000, emma.burton@uea.ac.uk
About this study
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
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.
- Being tested
- Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 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. Receives: Other: Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 months
Secondary outcomes (3)
Clinical Outcomes in Routine Evaluation Outcome Measure (CORE-OM) - Change in psychological wellbeing
The CORE-OM measures: Psychological wellbeing, functioning, symptoms and risk
Measured: 2 months
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
Measured: 2 months
Session Rating Scale (SRS) - Completed after each session
Used to measure the participant's views of each session
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2017
- Study start11 Apr 2017
- Primary completion1 Nov 2017 (estimated)
- Study completion1 Sep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for At Risk Mental StateStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of East Anglia
- Sponsor type
- University, hospital or other
- Collaborators
- Norfolk and Suffolk NHS Foundation Trust
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03160092
- Sponsor's protocol ID
- 212935
- Status last verified
- May 2017
- First submitted
- 12 May 2017
- Last updated
- 19 May 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03160092
- Acronym / sponsor ID
- 212935
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- University of East AngliaUniversity, hospital or other
- Collaborators
- Norfolk and Suffolk NHS Foundation Trust
- Study start
- 11 Apr 2017 (actual)
- Primary completion
- 1 Nov 2017 (estimated)
- Study completion
- 1 Sep 2018 (estimated)
- First posted
- 19 May 2017 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: InterventionClinical 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. |
Who may qualify
- Ages
- 16 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| InterventionThe 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. | Other | Intervention |
Primary outcome
Comprehensive Assessment of At Risk Mental State (CAARMS) - Change in At Risk Symptoms
Time frame: 2 months
This is a 30 minute semi-structured interview, measuring the intensity, duration and frequency of subthreshold psychotic symptoms
3 secondary outcomes
Clinical Outcomes in Routine Evaluation Outcome Measure (CORE-OM) - Change in psychological wellbeing
Time frame: 2 months
Revised Short Version of the Working Alliance Inventory (WAI-SR)
Time frame: 2 months
Session Rating Scale (SRS) - Completed after each session
Time frame: 1 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2017.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Central Norfolk Youth Team, 80 St Stephens Road
Norwich, United Kingdom
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention in people with At Risk Mental State and Attenuated Psychotic Symptoms, run by University of East Anglia 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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 19 May 2017. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comprehensive Assessment of At Risk Mental State (CAARMS) - Change in At Risk Symptoms (time frame: 2 months). 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 19 May 2017.