Plain English Summary
Background and study aims
We have found that heartbeat timing (heart rate) affects the way the brain processes fear. This is called Cardiac Control of Fear in the Brain (CCFIB). This effect is present in 75% of the population and its possible that it is linked to mental health problems. We want to find out whether more people with anxiety disorder display CCFIB compared to other type of patients. In a follow-up study, we will also find out whether CCFIB can predict how well treatments will work.
Who can participate?
Adults who currently use mental health services.
What does the study involve?
Participants are asked to complete questionnaires that gather information on their symptoms of mood and anxiety, how severe their disorder is, their quality of life, medical history, and how they see their own body (body perception). Participants also complete some computerised tasks that measure their interoceptive awareness (awareness of, for example, heartbeat, “butterflies in the stomach” or being aware of face flush) while using a finger sensor to measure their pulse.
What are the possible benefits and risks of participating?
There are no immediate benefits from taking part in this study. Although this research may not directly benefit participants, it could result in new ways of treating anxiety and other mental health symptoms in the future. There are no risks in participating in the study. Information from the study will be protected and anonymous so that people will not have access to the information about who took part or find out results of any one individual.
Where is the study run from?
1. Assessment and Treatment Centre East, East Brighton Community Mental Health Centre, Brighton General Hospital, Brighton (UK)
2. Assessment and Treatment Centre West, Mill View Hospital, Hove (UK)
3. The University of Sussex, Falmer, Brighton (UK)
When is the study starting and how long is it expected to run for?
July 2014 to May 2017.
Who is funding the study?
European Research Council (Belgium)
Who is the main contact?
Dr Cassandra Gould
C.Gould@bsms.ac.uk
Trial website
Contact information
Type
Scientific
Primary contact
Dr Cassandra Gould
ORCID ID
Contact details
Clinical Imaging Sciences Centre
University of Sussex
Brighton
BN1 9RR
United Kingdom
-
c.d.gould@sussex.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
16309
Study information
Scientific title
Cardiac Control of Fear in Brain: relationship to anxiety symptoms: an observational study
Acronym
CCFIB
Study hypothesis
Primary objectives are to determine whether the cardiac control of fear in the brain (CCFIB) is linked to anxiety disorder (i.e. whether a greater proportion of anxiety patients express CCFIB than other patient groups and control groups).
Ethics approval
13/LO/1866MHRNA; First MREC approval date 22/01/2014
Study design
Non-randomised; Observational; Design type: Qualitative
Primary study design
Observational
Secondary study design
Cross sectional study
Trial setting
Other
Trial type
Other
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Topic: Mental Health; Subtopic: Anxiety; Disease: Anxiety
Intervention
Participants will first give informed consent and will then perform computerized measures of interoceptive awareness and CCFIB. CCFIB is a clinical screening tool. The usefulness of CCFIB as a clinical screening tool will be evaluated against symptom expression within a clinical population. We will examine whether CCFIB predicts treatment effectiveness. Physiological equipment is applied with participant seated, including application of finger sensors for heartbeat measurements using a pulse oximeter.
The second component of the study is a follow up study. Patients assessed within the survey, and assigned to a cognitive behavioural therapy (CBT) programme or a course of SSRI medication, will be followed up.
Updated 17/07/2015: All patients assessed within the survey will be followed up.
Follow Up Length: 6 month(s)
Intervention type
Other
Phase
Drug names
Primary outcome measure
Patient survey: Is CCFIB linked to anxiety disorder?
Secondary outcome measures
Patient survey: Does CCFIB predict treatment effectiveness?
Overall trial start date
14/07/2014
Overall trial end date
31/05/2017
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Previous inclusion criteria:
1. Service User (GP surgeries, Well-being services, Health in Mind, and Assessment and Treatment Services, Brighton and Hove)
2. Diagnosed with any mental health problem
3. Target Gender: Male & Female ; Lower Age Limit 18 years
Current inclusion criteria as of 17/07/2015:
1. Service User (GP surgeries, Well-being services, Health in Mind, and Assessment and Treatment Services, Brighton and Hove)
2. Diagnosed with anxiety disorder
3. Target Gender: Male & Female ; Lower Age Limit 18 years
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned Sample Size: 300; UK Sample Size: 300
Participant exclusion criteria
1. A significant history of cognitive impairment or a neurological condition
2. History of substance abuse
3. Alcohol intake during that day
Recruitment start date
14/07/2014
Recruitment end date
31/03/2016
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Clinical Imaging Sciences Centre
University of Sussex
Brighton
BN1 9RR
United Kingdom
Trial participating centre
Assessment and Treatment Centre East
East Brighton Community Mental Health Centre
Brighton General Hospital
Brighton
BN2 3EW
United Kingdom
Trial participating centre
Assessment and Treatment Centre West
Mill View Hospital
Hove
BN3 7HY
United Kingdom
Funders
Funder type
Government
Funder name
European Research Council; Grant Codes: 324150CCFIB
Alternative name(s)
ERC
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list