Cardiac Control of Fear in Brain: relationship to anxiety symptoms

ISRCTN ISRCTN13588109
DOI https://doi.org/10.1186/ISRCTN13588109
Secondary identifying numbers 16309
Submission date
21/08/2014
Registration date
16/12/2014
Last edited
20/05/2021
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

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

Contact information

Dr Cassandra Gould
Scientific

Clinical Imaging Sciences Centre
University of Sussex
Brighton
BN1 9RR
United Kingdom

Email c.d.gould@sussex.ac.uk

Study information

Study designNon-randomised; Observational; Design type: Qualitative
Primary study designObservational
Secondary study designCross sectional study
Study setting(s)Other
Study typeOther
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleCardiac Control of Fear in Brain: relationship to anxiety symptoms: an observational study
Study acronymCCFIB
Study objectivesPrimary 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(s)13/LO/1866MHRNA; First MREC approval date 22/01/2014
Health condition(s) or problem(s) studiedTopic: Mental Health; Subtopic: Anxiety; Disease: Anxiety
InterventionParticipants 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 typeOther
Primary outcome measurePatient survey: Is CCFIB linked to anxiety disorder?
Secondary outcome measuresPatient survey: Does CCFIB predict treatment effectiveness?
Overall study start date14/07/2014
Completion date31/05/2017

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participantsPlanned Sample Size: 300; UK Sample Size: 300
Key inclusion criteriaPrevious 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
Key exclusion criteria1. A significant history of cognitive impairment or a neurological condition
2. History of substance abuse
3. Alcohol intake during that day
Date of first enrolment14/07/2014
Date of final enrolment31/03/2016

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centres

Clinical Imaging Sciences Centre
University of Sussex
Brighton
BN1 9RR
United Kingdom
Assessment and Treatment Centre East
East Brighton Community Mental Health Centre
Brighton General Hospital
Brighton
BN2 3EW
United Kingdom
Assessment and Treatment Centre West
Mill View Hospital
Hove
BN3 7HY
United Kingdom

Sponsor information

Sussex Partnership NHS Foundation Trust (UK)
Hospital/treatment centre

Sussex Education Centre
Nevill View Hospital
Hove
BN3 7HZ
England
United Kingdom

ROR logo "ROR" https://ror.org/05fmrjg27

Funders

Funder type

Government

European Research Council; Grant Codes: 324150CCFIB
Government organisation / National government
Alternative name(s)
ERC

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
HRA research summary 28/06/2023 No No

Editorial Notes

20/05/2021: Proactive update review. No publications found. Search options exhausted.
On 13/04/2016 the recruitment end date was changed from 31/05/2017 to 31/03/2016.