Further development of a new model of generalised anxiety disorder: effects on processing of emotional material

ISRCTN	ISRCTN76669810
DOI	https://doi.org/10.1186/ISRCTN76669810
Secondary identifying numbers	N0264192826

Submission date: 28/09/2007
Registration date: 28/09/2007
Last edited: 07/07/2017

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

Not provided at time of registration

Contact information

Dr Marcus Munafo
Scientific

C/O Research and Effectiveness Department
Level 1, Old Building
Bristol Royal Infirmary
Marborough Street
Bristol
BS2 8HW
United Kingdom

Phone	+44 (0)117 928 3473
Email	R&E@ubht.nhs.uk

Study information

Study design	Double-blind placebo-controlled randomised crossover study
Primary study design	Interventional
Secondary study design	Randomised cross over trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet
Scientific title	Further development of a new model of generalised anxiety disorder: effects on processing of emotional material
Study objectives	This study will enable us to learn more about how the inhalation of carbon dioxide (CO2) produces anxiety. We can examine the psychological mechanisms of CO2-induced anxiety and see how these influence the processing of emotional material. These findings will aid our understanding of anxiety and validate the CO2 model for use in studies of potential new treatments. It is widely accepted that anxiety results in altered processing of emotional material. Anxiety is also associated with physical symptoms such as racing heart, raised blood pressure, and muscle tension. We aim to examine the relationship between heart rate and blood pressure and altered processing of emotional material (i.e., are changes in the physical response to CO2 related to changes in the psychological response?).
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	General anxiety disorder
Intervention	Participants will complete a single test session, which will consist of the inhalation of air and the inhalation of 7.5% CO2, in counterbalanced order.
Intervention type	Other
Primary outcome measure	Measures of processing of emotional information
Secondary outcome measures	Subjective measures of anxiety and cardiovascular function
Overall study start date	01/01/2007
Completion date	01/01/2008

Eligibility

Participant type(s)	Healthy volunteer
Age group	Adult
Lower age limit	18 Years
Upper age limit	55 Years
Sex	Both
Target number of participants	20
Key inclusion criteria	1. Male and female participants 2. Aged 18-55 3. With a normal medical and psychiatric history, physical examination and ECG who give signed, fully-informed consent to participate
Key exclusion criteria	1. Females who are pregnant, breastfeeding, or not using adequate contraception 2. Presence of any pathological condition 3. Personal history of current or past psychiatric illness by psychiatric interview 4. Strong family history of mood disorder, including panic disorder 5. Personal history of cardiovascular or respiratory disease, including asthma 6. Personal history of migraine headaches requiring treatment 7. Cigarette smoking in the last 6 months 8. Drinking more than the recommended units of alcohol per week 9. Personal history of alcoholism or drug dependence 10. Drinking more than 8 caffeinated drinks per day 11. Medication use (except local treatment, or aspirin or paracetamol) within 8 weeks of testing 12. Potential, in the opinion of the investigator, to be non-compliant with study
Date of first enrolment	01/01/2007
Date of final enrolment	01/01/2008

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Bristol Royal Infirmary

Bristol
BS2 8HW
United Kingdom

Sponsor information

Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Government

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Phone	+44 (0)20 7307 2622
Email	dhmail@doh.gsi.org.uk
Website	http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

United Bristol Healthcare NHS Trust

No information available

NHS R&D Support Funding

No information available

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

Editorial Notes

07/07/2017: No publications found, verifying study status with principal investigator.