what is the study about?
Cognitive-behavioural therapy (CBT) is an effective talking treatment for anxiety disorders, but courses are long and difficult to access. However, we have recently shown that even a single session of CBT already has an effect on anxiety. On the other hand, research has shown that a simple blood pressure medication called losartan can improve cognition and memory. In this study, we would like to test whether combining a single-session of CBT with losartan can improve effects on anxiety, and what the underlying brain mechanisms of such an enhancement effect are. We would like to test two groups of people with panic attacks: one who receives CBT after having taken a single capsule of losartan, and one who receives CBT after having taken a placebo capsule. In particular, we would like to monitor your anxiety throughout the study and measure the activity of your brain on the day after treatment, while you are reacting to different types of emotional information. It is hoped that the knowledge gained from this study will contribute to the improvement of treatment for people who experience distressing panic attacks and anxiety disorders.
What is Cognitive-behavioural therapy (CBT)?
CBT is a form of psychotherapy based on the concept that the way we think about things affects how we feel emotionally. Thus, it aims at helping people to modify the way they think and the way they act. The underlying assumption is that learning processes play an important role in overcoming anxiety. Previous research suggests that this type of therapy is very effective in the treatment of anxiety disorders. In this study, we will only be able to offer one session of CBT. Full CBT treatment for panic disorder typically involves around 6-10 sessions, thus we do not expect that you will necessarily be free of all your symptoms after the brief intervention. Nevertheless, our previous work suggests that the majority of people experience a significant improvement in their symptoms at this point.
what is LOSARTAN?
Losartan is a medication for high blood pressure which has had UK market authorisation for 20 years. Recent research suggests that this drug can also improve cognition and the effects of learning experiences. As a side effect, some participants experience symptoms such as drowsiness, muscle weakness, low blood sugar, headaches, hypotension or allergic reactions. However, if you are randomised to the losartan condition you will only be asked to take a very low, single dose of 50mg, which is equivalent to what you would be prescribed daily if you had high blood pressure. Recent studies have shown that taking such doses is very unlikely to cause side effects.
what does the study involve?
If you decide to volunteer, you will be asked to come to the Warneford Hospital or the John Radcliffe Hospital on five occasions over 6 months.
1. Screening visit
During your first visit we will make sure that it is safe for you to take part, and that you are suitable for this particular study. We will also give you the chance to ask any questions you might have. This session will involve asking you to give us some information about your medical history, to complete a routine medical examination, and to answer some detailed questions about your psychological well-being.
2. Treatment Visit
During this visit, you will receive a session of CBT, either in combination with 50mg losartan or placebo. Which one of these treatments you will receive will be randomised, and until the end of your study participation, neither you nor the experimenter will be aware which treatment you have received.
3. Testing Visit
On the day following your treatment, we will ask you to undergo an MRI scan - please note this part of the study is voluntary and you do not have to have an MRI scan! The scan will take about 45 mins and we will ask you to respond via a button box to simple cognitive tasks displayed on a screen that you can see whilst in the scanner.
4. Follow-up Visits (Warneford Hospital)
One month and 6 months after your treatment, we will re-assess your anxiety, using questionnaires and a brief interview.
1. Screening visit
During your first visit we will make sure that it is safe for you to take part, and that you are suitable for this particular study. We will also give you the chance to ask any questions you might have. This session will involve asking you to give us some information about your medical history, to complete a routine medical examination, and to answer some detailed questions about your psychological well-being.
2. Treatment Visit
During this visit, you will receive a session of CBT, either in combination with 50mg losartan or placebo. Which one of these treatments you will receive will be randomised, and until the end of your study participation, neither you nor the experimenter will be aware which treatment you have received.
3. Testing Visit
On the day following your treatment, we will ask you to undergo an MRI scan - please note this part of the study is voluntary and you do not have to have an MRI scan! The scan will take about 45 mins and we will ask you to respond via a button box to simple cognitive tasks displayed on a screen that you can see whilst in the scanner.
4. Follow-up Visits (Warneford Hospital)
One month and 6 months after your treatment, we will re-assess your anxiety, using questionnaires and a brief interview.
inclusion and exclusion criteria
We are looking for participants over the age of 18 who are experiencing panic attacks. You may not be able to take part if you:
- have a history of epilepsy or seizures, or other severe diseases such as kidney, liver, heart or respiratory problems
- have a history of a psychotic disorder or bipolar disorder
- are pregnant or breast-feeding
- are taking certain medication
- will not be able to refrain from benzodiazepines for 48 hours before the sessions.
what is MRI?
MRI is an abbreviation for Magnetic Resonance Imaging. An MRI scan uses a combination of a strong magnet and radiowaves to produce detailed pictures of the inside of the body, such as the brain, heart or knees. In this study, we will be taking picturres of your brain while you are working on computer tasks. Later, when we analyse your data, we will be able to see which parts of your brain were “active” when you were working on the task. These areas will be highlighted in colors. in particular, we are interested in the effects of d-cycloserine on brain function. This information will help us to further develop more effective treatments for anxiety.
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What does an MRI scanner look like?
The MRI scanner is a big machine with a tunnel through the middle. It has a bed to lie on and a place to rest the head. The bed is moved into this tunnel so that the region to be scanned – in this case the head - is in the centre. |
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Is the scan safe?
Yes. There are no x-rays involved and the scan will be painless. As you probably know best, some people might feel claustrophobic in a scanner. We have a lot of experience in working with patients with panic disorder and will give you all the information and time you need to get used to the scanner. |
We have noticed that even the most anxious patients usually feel surprisingly comfortable after the first few minutes in the scanner. Nevertheless, we will continuously be in touch with you during the scan, and you will be able to stop the procedures at any time.
study materials
| participant_information_sheet_version_2_150116.pdf |
| Panic Screening Questionnaire.pdf |
contact
Please get in touch if you would like to take part in this study, and do not hesitate to also let us know if you have any questions or worries about a potential participation.
Dr. Andrea Reinecke
Group Leader
Email: andrea.reinecke@psych.ox.ac.uk
Phone: +44 01865 618320
Dr. Andrea Reinecke
Group Leader
Email: andrea.reinecke@psych.ox.ac.uk
Phone: +44 01865 618320
