The thing that I found most interesting was that I actually had never been given a proper diagnosis before, and I’d gone to this unit and I’d been given a proper diagnosis. I’d been offered the most up-to-date treatment, which seemed to have, the early results were quite encouraging, people seemed to do well. And that my psychiatrist was quite encouraging, whereas before the other psychiatrists who had treated me were quite negative and quite pejorative actually towards me. He was, he didn’t see me as difficult. He saw me as challenging and complex, but not difficult.

 

And it was his area of expertise. And that made me feel as a patient that, that there was some hope for me, whereas traditionally in the past I was seen as, as someone quite difficult. It, it was really nice to be with a team who were really quite encouraging. They weren’t just doing it in terms of a research thing, but also because they had a genuine compassion and interest for people to get well. And they were researching this subject because they only wanted to offer the very best treatment, not just treatment that they didn’t know where it was going. And for me that, that was very encouraging.

 

As, I was in treatment for, in the day unit for three years and that, for that time, that’s when the trial sort of went on. And there were some people who opted out. And my own view was that was sad, because I think that, you know, every person who had the chance should have entered, because even if treatment wasn’t successful for them, that we, it could have been explored within, as part of the research process, to find out a bit more about, about what does and doesn’t work. 

There was, there have been clinical trials. There was one called IPCRESS, which looked at the use of computerised behavioural therapy for the management of anxiety disorders. And it basically involved people sitting in front of a computer using an evidence-based computer programme, and receiving sort of so many sessions of structured help using a computer programme. And they were supported by an assistant psychologist through, through that process. And then of course you have another group who might just have some counselling, and seeing which gets the better outcome. Now the aim isn’t to replace - with horror I can see people thinking, “But, you know, we’ve got therapists out there. Why do we need computers?” Some people initially might be very reluctant to come forward, but they might be very happy to sit in front of a computer initially. And it’s a gentle introduction to some, a behavioural method that has been tried and tested. And I think it’s not just about the fact that it was rigorously tested by one university and various Royal Colleges, it was more about actually that it was for a certain group of people, because different treatments can suit different people. But it may not be the way the treatment is presented. I think that some people want treatment in primary care, some people do want to go and see the hospital specialist, and some people just want to sit in front of a computer if they’ve got busy lives. So this was quite innovative.

 

And the original work, there was an original package that was developed at the University of Leeds, and then further packages were developed in other academic settings. And I think this was quite remarkable. So what the trial looked at was how effective in early-onset anxiety disorders this treatment was. And what we now have of course is - and of course there were good outcomes, people, you know, a certain group of people were helped fundamentally and found that treatment really did help them, whereas other people needed to go onto more structured face one-to-one therapy. The benefits of that is that it’s very low cost, the licensing of the equipment, of the programme is, is inexpensive, whereas to employ one psychologist, one CBT therapist might be £30-40,000 a year - plus you’ve got the accommodation problems and fitting it into people’s lives, not taking time off work or whatever - is that you can have a programmer, a stand-alone machine, and that machine can be used all day, 24/7.

 

You know, or people can access the programme through their computer at home. And I think that there’s something quite innovative about that.

Well, basically if you’re, I would say to people that there’s two, two things. Firstly, if you’re having clinical treatment for any medical condition and you feel that things aren’t improving the way you may have hoped for, or that you just are not happy, you need to obviously investigate that further, go and research that further. There’s some really good websites out there, and always go and look out for information, responsible websites. One good way of knowing whether the information is correct is on the websites there’s the HONcode [Health on the Net], which is a, a regulatory code that looks, that monitors the standards of clinical websites. So if you go to one of the HONcode websites, there’s no direction but you just hit and miss till you find one of those, or one of the standard medical websites that are advertised, and look up about treatment. Because there’s always loads of things going on about research. And if you want to participate and you’re not sure, don’t feel put off. If you know there’s a hospital where there’s research going on and you’re not sure whether you would be accepted or not, you can, you could phone them up. You can phone up, you could phone up the academic department and say, you know, “I’m a patient. I’m interested in such-and-such, getting treatment for such-and-such. You know, if my GP refers me, you know, is this something that, that I can get involved in or be seen by someone who’s got a strong academic interest?”

 

That’s the first thing, I would say. Because the first step about finding out about something is not just the research on the net, but finding out what’s happening in your local academic department. So that, that’s the first thing I would recommend. Don’t be afraid of talking to them. They have administrators who are incredibly knowledgeable about what goes on in the department. Talk to them and find out what’s going on. And talk to your GP or your current specialist. And if your current specialist says to you, “What do you want to go and do that for? You’ll get loads of questionnaires and stuff”, say to them, “It’s not that I think you’re a bad specialist, far from it, but I want the best treatment to give me the best outcome.” And in order to do that, you’ve got to do your best research. And I think stick to your guns and go for it.

 

What I would say to professionals is that, “If you’re not involved in research, why aren’t you? Go out and get some training or go and do, go to some lectures and get out of the rut.” There’s something very exciting about research, and I think that it’s about doing the very best you can. We owe it to everybody, not just so that we don’t get stuck in a rut doing the same thing because we’ve always done it before, but making the best use of resources.  

And that’s the other, that’s the other issue as well, is that the issues that happened at Northwick Park* are rare. And every trial has a risk, we know that, of course we do. But, you know, the chance of that happening is quite low, not because the drugs aren’t necessarily seen as safe at that stage, but because the safety precautions are much more rigorous. We’ve now got, you know, the Research Governance Framework, which is, I think, become much more rigorous in time. And also the, the way research and consent is carried out is much, much better. The clinical standards have improved, as have the standards in things like clinical practice in research, which have been revised and, I think, and are continually being scrutinised. I know some researchers see it also as a, as a bar to research, all this unnecessary paperwork and regulations and stuff. But at the end of the day, it’s patient safety that’s important. And it’s important that the public are aware that, you know, that there’s, you know, a shed load of policies out there to help them keep, to help the safety be maintained. And that traditionally research, you know, was seen as higher risk many years ago, as they had less effective monitoring. I think today with the increase of information technology, with the increase of, you know, testing facilities - we’ve got very advanced now screening facilities, it’s much, much better. So I think that makes it safer. And also the public are aware that, that research isn’t just about, you know, rare cancers or something, but that it is about very day-to-day stuff. Like, you know, it might be looking at a, at a cholesterol-lowering drug, or it might be looking at ways of managing stress using a computer programme.

FOOTNOTE: Fenella is referring to an incident in 2006 when healthy volunteers in a phase 1 trial at a commercial research unit based at Northwick Park Hospital became extremely ill. A copy of the Inquiry Report of this incident can be downloaded from the Department of Health website:

And I was given the diagnosis, which I hadn’t been given before, of borderline personality disorder by the psychiatrist. And I went into treatment, which was a five day a week therapy programme, which involved different groups and individual therapy. And I found out that the treatment was using something called partial hospitalisation, which meant that you weren’t in hospital but you weren’t out of hospital. You were kind of as a day patient, really. I did that for two years. But the treatment itself was focused upon a new approach developed by my psychiatrist, who had a very strong academic interest in psychiatry, and it was called mentalisation-based treatment.

 

And mentalisation was basically focusing on how you think about things, and about how you view other people. Because in borderline personality disorder you see the world as one way. It could be black, or it could be white. Somebody could do something and it will either upset you or delight you, but there’s no stable area in between. And also you only consider your viewpoint and it can be quite difficult to take on the other person’s viewpoint. So if somebody, for example, was late meeting you, you may think that they’ve not turned up. But maybe their car broke down or they couldn’t get to a phone or something happened. But as part of the illness it was difficult to take that on board, because your cognition, as they say, were kind of, it was somewhat impaired, which went back to all sorts of theories. There’s all sorts of theories about it.

 

But the treatment involved shifting that distortion, so that you were able to think about that, and think about other people’s responses and how you interact with people better and can then hold and maintain relationships.

 

The treatment that I went into, unbeknown to me at the beginning, was part of a clinical trial. And I wasn’t entered into the trial without my knowledge at all. In fact there were regular discussions in the day hospital about the trial, and what they were doing, and that they encouraged new people joining the day programme to come into the trial. You didn’t have to. It didn’t, wouldn’t affect your treatment whether you did or if you didn’t. But they wanted to show, to have as much evidence as possible to show after a period of time that the treatment worked. So I was encouraged to come into the trial. And what that involved was that I was given quite a lot of questionnaires to fill in. And at times you just didn’t feel like filling them in, but it was really quite important, because it monitored all sorts of things round your mental state, about whether the treatment was working or wasn’t. And it was quite interesting. And then I was also interviewed by a research assistant who had no access to my clinical notes or clinical care, where I was, every three months. So I would sit down and answer certain questions.

 

There were, some questions were open questions where I could prattle on for ages, and other questions were closed where they wanted, “Yes” or, “No”. Some was quite qualitative, where it was about how I was feeling rather than anything quite fixed. And, you know, and then there were other parts, which was more quantitative, where I was asked to score things on a score of 1 to 10 type thing. And it was part of the questionnaires and interview process.  

I was very, very delighted and impressed when my psychiatrist told me at a follow-up appointment that I went to, that the paper he had written up had been accepted into the American Journal of Psychiatry, because I’d heard that, that it’s very, very difficult to get a paper published in there and that only the very best get stuff published. And I felt quite, quite touched that I was part of that process to help inform about a treatment. I hadn’t read the paper yet. So I was, I mean I think I was a bit nervous. But I was given a copy of the paper when it was published. And it was very rewarding for me to see that not only had I got better but also on paper that a whole group of people had got better. And it was evidence-based through the research. And it was published in a very eminent journal. And that for me felt like something quite special, because I knew I was then helping other people. And also spread the word about good treatment, because I knew then that other psychiatrists would be reading that, and thinking, “Oh, you know, this is something new. I didn’t know about it. This is really good news because before we thought people maybe didn’t get better.” Because traditionally BPD [borderline personality disorder] was seen as untreatable. But this ground-breaking research had shown that it was actually treatable. And this for me was quite important. 

 

Well, it wasn’t automatically sent to me, but it was offered in the sense that my psychiatrist did tell me at one of my appointments that it was going to be published, and he did tell me about the results, very basically talked to me about the results, just to inform me. But I - and, you know, and he said to me did I, asked me if I wanted to see the paper and I said, “Yes” and, you know, and then, then I was, you know, given a copy. But I am also very aware that there are a lot of people who do take part in trials who never ever get to hear about the final outcomes, and also if the papers are written up and published, never given a copy of the clinical paper that’s published. And there are various reasons for that. One may be that, that the, it may be assumed that the patient doesn’t have enough knowledge to understand what a clinical paper is saying in terms of jargon and the way the statistics are presented. The other may be, of course, that, you know, clinical journals traditionally are held in the privy of medical school buildings or hospital libraries or, you know, online. Patients aren’t going to hold the privileged ATHENS number to get access to the journal.

 

So it, it is difficult. And if a patient - and some patients may also have this fear of contacting somebody, you know, like the great surgeon, surgical professor or, you know, the top-notch cancer specialist type thing, when actually they’re human beings just like us and, and they use our information. So I’m, I’m very aware that that happens.

 

 

I feel very strongly about this. One of the things that I do is I work with the Mental Health Research Network. And one of the regional areas, the north London hub of the network is, we’ve got, you know, I do work with, with them, and I’m very, very proactive in promoting the whole issue about discussing the outcomes with trial participants. In fact, I was discussing recently with one of the research professors, who was doing a trial which had a six-month gap in between when they did their first interviews and their second lot of interviews. We were discussing how they can maintain contact with patients and keep them in touch with it, without it being too formal. So instead of them getting a bland letter through the post saying, “Dear Mr Bloggs, how are you? We’re just checking you’re still participating”, how can we - and, you know, and keeping in touch right until the very end of the trial, and then obviously keeping in touch thereafter.

 

And one of the ideas we came up with was about a postcard. You know, you get a lot of junk mail in the post and these postcards that come in from companies selling themselves. Well, I had this idea that a postcard could be designed and it may be, the cost may be sponsored or incorporated into the trial cost. If it’s a drugs trial, the pharma company could sponsor that. If it’s a non-drugs trial, it could be incorporated into the costing. And this would be a really nice, bright coloured card, and it would just be pre-printed with a picture on one side and on the other side the researcher could just write a little handwritten note to that person. And then put it in a, a normal plain envelope, you know, and post it to all the trial participants.

 

And just basically keeping in touch with them and sending them a card every, maybe every eight weeks, right up until the very end. And then at the very end having a meeting to say, “This is what the outcomes were.” And this is kind of something we’ve taken on board, because it’s incredibly important not just to get people onto a trial, but to have respect and to share the information and the outcomes at the end of the process. And make it accessible information, so not just also dishing out a clinical paper that’s out of some journal that may be out of the reach of many, you know. So, you know, obviously arranging a talk or a discussion or an evening where people can come and just have an informal question-and-answer session and a brief presentation about what happened.

 

Yes, it was actually. My, it was basically because my psychiatrist was very active in clinical research. He was always writing papers and doing presentations and stuff. And I wanted to be part of that buzz. I would go to a lecture or something and think, “Wow, this is really interesting” because a lot of research had gone into stuff and it fascinated me. So basically I found out a bit more about it, and I made some contact. And it was really nice getting in touch with my local office. I was welcomed in. I wasn’t treated as, “Oh, you know, you’re not important” or anything. Because in actual fact now, basically the way governance arrangements are around research is that you have to have obviously service user involvement. So, and they didn’t just accept me because they knew they had to involve me to get their funding - because I know that that happens, where clinicians say, “Here, sign here. Fill in that box. Then I can get my money” you know [laughs], type thing. I’ve heard that happen, I’ve heard where people have been taken out for dinner and, you know. It rarely happens now. But we are still having a bit of tokenism, though, where actually the meaningful involvement is still not quite there. However, I was fully, fully involved and, you know, and I’ve got my place within the department, and I’m involved in all aspects of stuff. I’ve even, I even thought up my own proposal for a research project, which got a whole team together. And I sat in this room with all these academics. I could not believe it. There must have been about seven or eight psychiatrists all sitting in a room, and with a statistician and everyone, and all sitting there. And I’m sitting there thinking, “Wow.”

 

And I said to the one psychiatrist, “I’m thoroughly embarrassed. I’ve got you all here for half the day.” And the one psychiatrist said, “No, I think this is absolutely wonderful.” And we got actually shortlisted on one of them, but then we didn’t get past shortlisting. And I was really, really upset. And I remember the one researcher who had put the proposal together said, “Oh” he said, “Don’t worry.” He said, “Research for Patient Benefit will be here for years, so we can keep trying.” And I just thought [laughs], you know, it was just so lovely the way he said that and kind of, you know. And so it’s on the back burner. But we haven’t finished yet. So, you know, so for as long as, as the Institute for Health Research will be there, my proposal will be on the back burner. So that, that was lovely. And also I go on courses and stuff and I’m encouraged to do training and, you know, I help out on stuff. And I do have my own specialist area, which is around personality disorders and eating disorders. However - and psychological therapies - however I recently was approached by a professor who specialises in schizophrenia research, and it was quite nice to be asked to, to help out on that. And that wasn’t tokenistic because he was applying for money, but he genuinely wanted my advice knowing that I worked with other mental health service users. And it was really nice, you know, and it, it was a nice feeling. And I also went away and learnt more. And I also got given a great big textbook as well. So it was great.

So for example mental health is, is an area that, that is for me a priority. But I think, you know, we have to look at it on a very broad perspective. It’s not just about mental health. But we have, for example, areas around diabetes, where I think that the psychological impact and the mental health impact of such chronic diseases are not researched enough. And this in fact is something that, that health psychologists have spoken about for a long time. I think it’s, it’s about developing areas like that as well, because mental health isn’t mutually exclusive. I think if somebody sits down and says to you, “You’ve got a disease that could blind you. You could lose your foot. You know, your nerves are going to, might be dead in thirty years’ time off your foot” and all this sort of thing. Very scary things that can happen to you. Or, you know, “You’ve got to inject yourself for the rest of your life and, you know, and you’ve got all these risk factors.” It’s really, really scary. And people can become quite depressed as well, because they might feel their life is limited. It shouldn’t be, but they might feel their life is limited. And they may have also psychiatric difficulties as well. And the same set can be applied to cancer. It’s well know that people can get very depressed, you know, pro, post-recovery from treatment, because, you know, it’s kind of an anticlimax. They’ve had their treatment, they’re now better, and they’ve had all of this wonderful care around them, they might have been on a trial, they might not have been, but all of a sudden they are sent home and packing saying, “Oh, come back every three months for your check-up.” And that’s it.

 

And everybody sees them as better. And it can be quite difficult, quite - raise a lot of difficult emotions. And areas like this, where mental health is quite important, I think are not researched enough. And I think there’s more scope for clinical trials in non-drug areas of people’s lives, I mean which don’t involve medication. We’ve seen it, you know, in, in mental health but I think it needs to expand more into other clinical areas. So we can look at how, you know, people’s lifestyles or the effect of clinical treatment can affect people’s mental state or affect their physical well-being, but without there needing to be drugs involved.

 

At the same time I think that drug trials will continue, because they have to. We have to know that drugs are safe and that they work. But it’s not the be-all and end-all. I think that the expansion now of trials outside a medication route is growing, and I think there’s a lot of scope for that to be developed in all areas of medicine.