Extract

Background and study aims Generalised anxiety disorder (GAD), characterised by a tendency to worry, is the most common anxiety disorder in older people. It is associated with distress, difficulty in coping, poor quality of life and increased disability. Medication and talking therapy are usually offered to older people experiencing GAD, but for many this treatment is unsuccessful. Guidance as to how best manage this treatment-resistant GAD in older people is lacking. Acceptance and Commitment Therapy (ACT) is a type of taking therapy helps people to learn different ways of coping with distressing thoughts and feelings, and how to take part in more activities that are meaningful to them. It is helpful for reducing distress in other conditions including anxiety, depression, life-limiting illness and long-term pain. The aim of this study is to find out how acceptable and feasible it is to develop and deliver a new treatment program based on ACT to older adults with GAD. Who can participate? Older adults aged 65 years and over who have been diagnosed with GAD that has not responded to treatment (either medication and/or conventional talking therapy). What does the study involve? In the first part of the study, around 15 older people with GAD take part in an hour and a half long interview about their experiences of treatment. Information collected from these interviews is then discussed with healthcare professionals in order to create a treatment programme using ACT techniques. The participants are then interviewed again for their views on the programme. In the second part of the study, around 40 older people with GAD receive around 16 face-to-face sessions of ACT over 20 weeks plus usual care. These sessions are delivered within the GP surgery, outpatient clinic or participant's home by therapists attached to talking therapy and specialist mental health services. All therapists will receive training in ACT, as well as regular supervision. The sessions involve working with therapists to learn new skills to help better manage their GAD. At the start of the study and then again after 20 weeks, participants are asked to complete a number of questionnaires to assess levels of anxiety, worry, depression and quality of life, and to see how satisfied they are with the therapy they have received. What are the possible benefits and risks of participating? The main possible benefits include that participants will be given access to a novel form of talking therapy that is not yet available in the NHS for this condition. They will also be given a more in­depth screening assessment than they might otherwise receive as part of their routine NHS care. The main possible risks include that participants may experience a deterioration in anxiety and/or depression symptoms during the intervention (as it may not be beneficial for them) or distress during the interviews (e.g. when discussing their current difficulties). Participants will remain under the care of their GP or mental health professional during the study, and will be monitored and referred for further support if necessary. Where is the study run from? The study is taking place in multiple sites in: 1. Camden and Islington NHS Foundation Trust (lead trust) (UK) 2. South London and Maudsley NHS Foundation Trust (UK) 3. Oxford Health NHS Foundation Trust (UK) 4. Barnet Enfield and Haringey Mental Health Trust (UK) When is the study starting and how long is it expected to run for? June 2011 to January 2017 Who is funding the study? National Institute for Health Research, Health Technology Assessment Programme (UK) Who is the main contact? Dr Rebecca Gould [email protected]

Inclusion criteria

• Treatment-resistant generalised anxiety disorder in older people

Links

• isrctn