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 |
| Protocol serial number | N0264192826 |
| Sponsor | Record Provided by the NHSTCT Register - 2007 Update - Department of Health |
| Funders | United Bristol Healthcare NHS Trust, NHS R&D Support Funding |
- 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
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 |
|---|---|
| R&E@ubht.nhs.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Double-blind placebo-controlled randomised crossover study |
| Secondary study design | Randomised cross over trial |
| Study type | Participant 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(s) | Measures of processing of emotional information |
| Key secondary outcome measure(s) | Subjective measures of anxiety and cardiovascular function |
| 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 | All |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
Bristol Royal Infirmary
Bristol
BS2 8HW
United Kingdom
BS2 8HW
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
07/07/2017: No publications found, verifying study status with principal investigator.
