Condition category
Mental and Behavioural Disorders
Date applied
21/08/2014
Date assigned
16/12/2014
Last edited
13/04/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

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 measures

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

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

Sponsor information

Organisation

Sussex Partnership NHS Foundation Trust (UK)

Sponsor details

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

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

European Research Council; Grant Codes: 324150CCFIB

Alternative name(s)

ERC

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

Belgium

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

On 13/04/2016 the recruitment end date was changed from 31/05/2017 to 31/03/2016.