Plain English Summary
Background and study aims
Psychosis is a serious mental disorder in which thought and emotions are impaired, causing a person to lose touch with reality. The onset of psychosis is a major challenge for the patient and everyone involved in his or her care. It is unusual for psychosis to come on suddenly, and the NHS is keen to look at treatments to help stop the progression of psychosis for people at risk of developing it. Prevention is preferable to treatment for fully developed psychosis, because it is usually more acceptable and is generally associated with fewer side effects. It can also be more cost effective to provide prevention-based treatments. It is now possible to identify people who are at a high risk of developing psychosis. Early intervention teams around the country are working to help prevent the full onset of psychosis, as otherwise about one third will develop a full psychosis within three years. This study is going to look at treatments that aim to help reduce the number of people who develop psychosis. The aim of this study is to find out if adding family therapy to individual treatment is a helpful preventative treatment for young people at risk of developing psychosis.
Who can participate?
Young people aged 16-35 who are living with at least one member of their family and are at risk of developing psychosis.
What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group are offered combined individual and family Cognitive Behavioural Therapy plus their usual treatment. This involves a maximum of 25 individual cognitive behavioural therapy sessions (usually one per week) lasting up to an hour over a 6 month period, as well as 4-6 sessions of therapy with key family members or family support members. Therapy sessions will focus on whatever is of most concern to the participant at the time. Those in the second group continue to receive their treatment as usual, with no additional therapy from the research team. Participants in both groups will meet with a researcher for an initial assessment (which involves discussing current mental health difficulties and completing some questionnaires), and complete follow up assessments after 6 months and 12 months to repeat the initial questionnaires. Family members will also be asked to complete some questionnaires at the initial assessment, 6 month follow up and 12 month follow up assessment. Finally, a selection of those who take part are interviewed about their experiences in the study to help the research team decide whether a larger study should take place to explore the research further.
What are the possible benefits and risks of participating?
It is hoped that the combined individual and family therapy will be beneficial to those who are offered it but this cannot be guaranteed, and not everyone will be offered the therapy as part of the trial. This means there may be no direct benefits for those taking part in the study although many people find being involved in research to be a positive experience. There are no risks involved with taking part in the study. It is possible that some people may find talking about their mental health and their experiences distressing, however plenty of opportunities will be provided to discuss any concerns and participants can choose not to continue with the study if they wish.
Where is the study run from?
1. Greater Manchester West Mental Health NHS Foundation Trust (UK)
2. Bolton Early Intervention in Psychosis Team (UK)
3. Salford Early Intervention in Psychosis Team (UK)
4. Trafford Early Intervention in Psychosis Team (UK)
When is the study starting and how long is it expected to run for?
March 2016 to April 2019
Who is funding the study?
National Institute for Health Research (UK)
Who is the main contact?
1. Dr Heather Law (public)
2. Professor Paul French (scientific)
Trial website
Contact information
Type
Public
Primary contact
Dr Heather Law
ORCID ID
http://orcid.org/0000-0002-1889-9179
Contact details
Greater Manchester West Mental Health NHS Foundation Trust
Psychosis Research Unit-Rico House
Harrop House
Bury New Road
Prestwich
Manchester
M25 3BL
United Kingdom
Type
Scientific
Additional contact
Prof Paul French
ORCID ID
Contact details
Greater Manchester West Mental Health NHS Foundation Trust
Psychosis Research Unit-Rico House
Harrop House
Bury New Road
Prestwich
Manchester
M33 7FT
United Kingdom
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
30981
Study information
Scientific title
Combined individual and family therapy in comparison to treatment as usual for people at risk of psychosis: A feasibility study
Acronym
IF-CBT Trial
Study hypothesis
The aim of this study is to investigate whether a combined individual and family intervention is an acceptable, feasible and potentially effective treatment option for people with an At Risk Mental State (ARMS) for psychosis compared to standard treatment.
Ethics approval
North West - Greater Manchester East Research Ethics Committee, 26/05/2016, ref: 16/NW/0278
Study design
Randomised; Interventional; Design type: Treatment, Psychological & Behavioural
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Specialty: Mental Health, Primary sub-specialty: Psychosis; UKCRC code/ Disease: Mental Health/ Organic, including symptomatic, mental disorders
Intervention
Participants are randomised to one of two groups using a secure telephone randomisation system in a 1:1 ratio.
Combined individual and family therapy: Participants will be offered a combined individual and family Cognitive Behavioural Therapy plus their usual treatment. A maximum of 25 individual therapy sessions will be available (usually one per week) lasting up to an hour, over a 6 month period. Therapy sessions will focus on whatever is of most concern to the participant at the time. Alongside this, 4-6 sessions of Cognitive Behavioural Therapy with key family members or family support members will be available. These sessions will focus on making sense of experiences, communication styles, problem solving and goal setting.
Usual treatment alone: Participants in this study arm will not be offered any additional treatment from the study. They will continue with routine care or ‘treatment as usual’ from their care team or GP.
All participants will meet with a researcher for a follow up assessment at 6 months and 12 months after randomisation.
Intervention type
Other
Phase
Drug names
Primary outcome measures
Transition to psychosis as defined by the Comprehensive Assessment of At Risk Mental States at baseline, 6 and 12 months.
Secondary outcome measures
1. Time use is measured using the time use survey at baseline, 6 and 12 months
2. Depression is measured using the Beck Depression Inventory at baseline, 6 and 12 months
3. Social anxiety is measured using the Social Interaction Anxiety Scale at baseline, 6 and 12 months
4. Use of formal and informal health and social care is measure using the adapted EPQ at baseline, 6 and 12 months
5. Health status is measured using the EQ-5D at baseline, 6 and 12 months
Overall trial start date
01/03/2016
Overall trial end date
01/04/2019
Reason abandoned
Eligibility
Participant inclusion criteria
1. Aged 16-35
2. Screen positive on the Comprehensive Assessment of At Risk Mental States (CAARMS) for an At Risk Mental State
3. Be living with at least one member of their family
4. Help seeking
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned Sample Size: 76; UK Sample Size: 76
Participant exclusion criteria
1. Current or previous receipt of anti-psychotic drugs
2. Moderate to severe learning disability
3. Organic impairment
4. Insufficient fluency in English
5. Significant risk to self or others
Recruitment start date
27/06/2016
Recruitment end date
27/01/2018
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Greater Manchester West Mental Health NHS Foundation Trust
Psychosis Research Unit
Rico House
Harrop House
Bury New Road
Prestwich
Manchester
M33 7FT
United Kingdom
Trial participating centre
Bolton Early Intervention in Psychosis Team
Bentley House
Viking Works
Weston Street
Bolton
BL3 2RX
United Kingdom
Trial participating centre
Salford Early Intervention in Psychosis Team
Broadwalk Centre
51 Belvedere Road
Salford
M6 5EJ
United Kingdom
Trial participating centre
Trafford Early Intervention in Psychosis Team
Crossgate House
Cross Street
Sale
M33 7FT
United Kingdom
Sponsor information
Organisation
Greater Manchester West Mental Health NHS Foundation Trust
Sponsor details
Research and Development
Harrop House
Bury New Road
Prestwich
Manchester
M25 3BL
United Kingdom
+44 161 358 0594
Kathryn.harney@gmw.nhs.uk
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Government
Funder name
National Institute for Health Research
Alternative name(s)
NIHR
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
The main aims of the feasibility study, to inform a definitive study, will be delivered via descriptive data and analysis of data after the last follow-up assessment (post 01/04/2019). This will include reporting data in line with the CONSORT 2010 Statement. There will also be additional reporting of qualitative data. These findings will be written up for publication in high impact peer-reviewed journals. Additionally, findings will be presented at national and international conferences, as well as service user/voluntary sector organisations and networks and their newsletters and websites. Service-users involved in the study will be encouraged to participate in dissemination.
Intention to publish date
31/12/2019
Participant level data
Not expected to be available
Results - basic reporting
Publication summary