Extract

Background and study aims Depression is a health problem all over the world, with a considerable impact on the patient, on society and also economically. There are a number of treatments that work well, but only for about 60% of cases; many people do not receive any treatment at all and between 50-80% of patients that are treated go on to suffer more depression in the future. Preventing the development of depression is therefore important if we want to reduce the number of people suffering from the condition and the burden it places on society. Alternatives to the traditional face-to-face psychotherapy sessions are also needed to make sure that more people have access to treatments. One such approach is internet-based therapy, which has been shown to work in treating depression and anxiety in the past. However, to date, there have been few studies carried out that have looked at internet-based therapy (or intervention) to actually prevent depression. Here, we are investigating an internet-based intervention developed to treat stress, worry and rumination (dwelling on negative thoughts) in young adults. The underlying theory is that by targeting a specific risk factor, namely worry and rumination, people are less likely to develop depression or anxiety in the future. We are testing two different versions of the intervention, one supported by an online coach and the other purely self-help. While previous research has shown that supported therapy works better, self-help interventions could also be beneficial in that they have the potential to reach many more people who wouldn’t normally have access to therapy. Who can participate? Adults aged 18-24 who are prone to worry or ruminate and who are not currently depressed. Those with a history of depression can participate, provided they are currently well. What does the study involve? Participants are randomly allocated into one of three groups. Those in group 1 receive the internet-based intervention (i-RFCBT) guided by an online coach. Those in group 2 receive a self-help version of the intervention. Those in group 3 (control group) do not receive any treatment. Participants in group 1 are allocated to a trained online coach who will guide them through the internet therapy, giving feedback on the exercises and the participants themselves can send messages to their coach. The therapy consists of six modules, each taking 1-2 hours to complete online and we recommend spending 1-2 weeks on each module to allow time to practise the techniques. The modules include psycho-education, mood diaries, on-line experiential exercises using audio-recordings, pictures, and video vignettes of students’ experiences of the therapy. Each follows the same basic structure: reflection on previous session; introduction of new technique; practical exercises and planning how to practise or implement the technique in daily life. Participants are asked to complete some questionnaires assessing mood and depressive symptoms at the end of each module. The unguided intervention is a self-help version of the internet therapy, which contains the same content but without the therapist contact. There is no-one providing feedback on the exercises, but responses are monitored weekly so that we can check for and follow-up on any risk reported. Participants in the control group are asked to carry on as normal. They are allowed to access any other treatments if necessary throughout the study and will also have access to the unguided version of the intervention at the end of the study if they wish. All participants are contacted at regular intervals (initially at 3 months from entering the study, and then 3 months and 1 year after that first follow-up) and asked to complete a short interview including questionnaires about worry, rumination and symptoms of anxiety and depression. What are the possible benefits and risks of participating? We have evidence to suggest that the therapy may be helpful in reducing stress and risk of later depression or anxiety. Participants may therefore find that the therapy helps them to manage their problems better. For those in the control group, involvement in the trial will not take up much of their time. It will only involve completing the measures four times over the course of the study. The regular follow-ups will allow us to track participants’ mood and tell them if any of their symptoms seem to be worsening. If their responses suggest that their mood requires attention, we may advise them to speak to their GP or a mental health practitioner. The information participants provide may help us to better understand how to prevent depression in young adults. This will hopefully allow us to provide better therapies that help young adults manage their stress and worry and reduce their risk of depression. The risks of participating in the study are minimal. There are no known side effects of the therapy and controls will simply be asked to carry on as normal. However, given the nature of the topic, participants may find answering some of the questions makes them feel uncomfortable. If participants report any suicidal thoughts, we will follow a well-established procedure for assessing and acting on suicide risk to ensure participants get appropriate clinical support. Where is the study run from? The University of Exeter (UK) When is the study starting and how long is it expected to run for? November 2013 to February 2016 Who is funding the study? University of Exeter, through a matched funded PhD studentship to a successful Wellcome Trust Capital Bid (UK) Who is the main contact? Lorna Cook [email protected]

Inclusion criteria

• Major Depressive Disorder; Generalised Anxiety Disorder

Links

• ictrp
• isrctn