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
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
Scientific
Clinical Imaging Sciences Centre
University of Sussex
Brighton
BN1 9RR
United Kingdom
| c.d.gould@sussex.ac.uk |
Study information
| Study design | Non-randomised; Observational; Design type: Qualitative |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cross sectional study |
| Study setting(s) | Other |
| Study type | Other |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Cardiac Control of Fear in Brain: relationship to anxiety symptoms: an observational study |
| Study acronym | CCFIB |
| Study objectives | 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(s) | 13/LO/1866MHRNA; First MREC approval date 22/01/2014 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | Patient survey: Is CCFIB linked to anxiety disorder? |
| Secondary outcome measures | Patient survey: Does CCFIB predict treatment effectiveness? |
| Overall study start date | 14/07/2014 |
| Completion date | 31/05/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 300; UK Sample Size: 300 |
| Key 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 |
| Key exclusion criteria | 1. A significant history of cognitive impairment or a neurological condition 2. History of substance abuse 3. Alcohol intake during that day |
| Date of first enrolment | 14/07/2014 |
| Date of final enrolment | 31/03/2016 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Brighton
BN1 9RR
United Kingdom
Brighton General Hospital
Brighton
BN2 3EW
United Kingdom
Hove
BN3 7HY
United Kingdom
Sponsor information
Hospital/treatment centre
Sussex Education Centre
Nevill View Hospital
Hove
BN3 7HZ
England
United Kingdom
"ROR" |
https://ror.org/05fmrjg27 |
|---|
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- ERC
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not 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.
