Treating Anxiety: a Feasibility Clinical Study Using Acupuncture and Cognitive Behavioural Therapy (CBT)
This feasibility study will compare the treatment of generalised anxiety disorder (GAD) using two therapeutic modalities: cognitive behavioural therapy (CBT) and acupuncture. For this purpose participants will be randomly divided into two groups: one will receive acupuncture and the other CBT.
The study aims to gather information on the potential benefits as well as safety, possible side effects and patients’ satisfaction of acupuncture compared to CBT, which is conventionally used in the NHS, to treat GAD.
Participation in the study is entirely voluntary.
The study has been approved by the Faculty Research Ethics Committee of the University of Westminster
You will be able to participate in the study if:
- You have been diagnosed suffering from generalised anxiety disorder (GAD) as primary condition by your GP or another medical professional; it must not be a self diagnosis.
- You have scored 10 or more in the GAD7 questionnaire (see below).
- You are 18 years or older.
- You have not had any psychotherapy, acupuncture or other treatments for at least six weeks before starting the study, but you are still suffering from GAD.
- You are on medication for GAD, providing you have not changed your prescription in the last six weeks before the beginning of the study.
- You are not pregnant or breastfeeding.
- You speak English
Before the study begins, you will have to give your written participation consent. You can do this by signing and dating the signature page at the end of this information letter. Next, the main research practitioner will interview you to make sure you are allowed to participate in the study. If this is the case, you will then be assigned randomly to one of the two treatment groups, acupuncture or CBT.
The initial consultation will take an hour, and the follow up sessions will last 45 minutes for both treatment modalities. Each participant will receive eight sessions of either acupuncture or CBT on a one-to-one basis. All the treatment sessions will take place once a week at the University of Westminster Polyclinic, Hanson Street, London W1W 6EA.
You will be asked to fill up two questionnaires (GAD7 and MYMOP) at the beginning, half way through and at the end of the study. GAD7 is a simple screening tool to measure the severity of anxiety disorder. MYMOP stands for Measure Yourself Medical Outcome Profile and aims to measure the outcomes that the patient considers the most important, it is problem specific but it also includes wellbeing.
If you decide to participate in this study, your participation will help us to find answers to our research questions. Therefore you can contribute to the development of medical knowledge of which you and other patients could benefit.
If you have any questions about the research, your rights as a participant, or would like to report any problem or injury arising from the research, please contact
E: [email protected].