Condition category
Mental and Behavioural Disorders
Date applied
13/06/2016
Date assigned
15/06/2016
Last edited
15/06/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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

Publication citations

Additional files

Editorial Notes