Medscape: Peter, you have just presented a poster entitled "Improving Antipsychotic Adherence in Schizophrenia: A Randomized Pilot Study of a Brief CBT [Cognitive Behavioral Therapy] Intervention." What led you to conduct the study, and what did you find?
Dr. Weiden: Well, the starting point here is that nonadherence to psychiatric medication is a huge public health problem. As most clinicians know, patients with schizophrenia will routinely stop their antipsychotic medications. In fact, nonadherence rates after relapse range from 50% to 80%. This is a huge problem because the benefits of treatments do not matter if you don't take your medications.
Dr. Weiden: If there were an easy answer to this problem, we would have found it by now. I think that as a field we are, perhaps, better able to say what does not work rather than what does work. When we look at psychosocial interventions for nonadherence in schizophrenia, studies of standard patient-based psychoeducation, we see that unfortunately patient education, for example, teaching about the biomedical model of schizophrenia and the necessity of medication to control symptoms, does not work; it does not improve medication adherence. Now, it is important to differentiate patient psychoeducation from family psychoeducation. Family psychoeducation has been shown to improve medication adherence for patients with families. So, I want to be very clear that I'm talking about patient education. While intuitively educating patients feels like the right thing to do, results of the research have been very disappointing.
Medscape: Why is that the case?
Dr. Weiden: There are many reasons. First, I would want to remind [the reader] that nonadherence is a huge problem across all medical and psychiatric disorders -- it is certainly not confined to schizophrenia by any means. There is a fundamental difference in schizophrenia compared with other medical, especially chronic medical, disorders, however. If you have asthma or diabetes or another serious chronic medical illness, compliance may be a problem, but for the most part, you are going to acknowledge that you have this illness. If the clinician designs an adherence intervention, therefore, he or she does not have to deal with the problem of what to do with patients who say they do not have this problem.
With schizophrenia, it is very different. The patient who says, "I don't have schizophrenia. I don't need treatment," is just the kind of patient we want to reach out to and help with their adherence problem. Yet, there is this catch-22 -- if we set up an adherence intervention for the person's schizophrenia that includes an educational program for his or her schizophrenia, we run the risk of turning off the very patient we want to help engage in treatment. That is, in my opinion, one of the central problems to psychosocial interventions to improve adherence in schizophrenia -- the lack of insight and not acknowledging having schizophrenia or whatever name for the psychiatric disorder is used is a real barrier to engaging people into taking medication.
We think, though, that we have found an answer to this problem, and that is what we were studying here -- are there ways that we can get around that fundamental problem?
Medscape: Tell us more about how you circumvent this fundamental problem.
Dr. Weiden: Since we know that many patients [with schizophrenia] do not acknowledge having an illness, some [of our] research has evaluated why patients do take their medication. Patients are more likely to take their medicine if you can find something that helps them feel better from the patient's point of view, especially if you can get the patient to come up with something on their own; that tends to be a very powerful motivator for adherence. Our work has uncovered another big reason why patients take their medicine -- their relationships. Research studies have shown, for instance, that married people are more adherent to regimens than single people, because there are many of us, like myself, who if I don't take my statin, for example, my wife will kill me.
I am doing it for that relationship. Our schizophrenic patients are no different; many of them take their medications because of a relationship -- a relationship with their doctor, with their therapist, or with a family member.
Now, what I had to do, as an adherence specialist, is to look for an intervention that would let me bypass this "you have schizophrenia" biomedical model. I could not find that in the United States (US). So I turned to the literature in England where there has been a growing body of evidence over the past 10 years showing that cognitive behavior therapy, or CBT, modified for patients with psychosis or schizophrenia (not the same CBT you give to someone with depression or anxiety) can actually help reduce core symptoms of schizophrenia, such as positive or negative symptoms.
The caveat for these CBT interventions is that the CBT is always added onto ongoing medication regimens. CBT is not a substitute for antipsychotic medications. In other words, for patients with schizophrenia who have persistent symptoms and are adherent to their medicine, a course of CBT has been shown to help reduce symptoms of schizophrenia.
So, I went to England along with 2 of my colleagues, Drs. Page Burkholder, MD, Professor of Psychiatry, Schizophrenia Research Program, Department of Psychiatry, State University of New York (SUNY), Downstate Medical Center, Brooklyn, New York; and Nina Schooler, PhD, Professor of Psychiatry, SUNY Downstate Medical Center, Brooklyn, New York and we were trained in this technique. A group there, led by Professors David Graham Kingdon, MD, MRCPsyc, Professor, Mental Health Care Delivery, Barrow Hospital, Gurney, Bristol, United Kingdom (UK), and Douglas Turkington, MD, Honorary Professor of Psychosocial Psychiatry, School of Neurology, Neurobiology and Psychiatry, Newcastle University, Newcastle upon Tyne, UK have developed these CBT techniques. Professor Turkington has done a study showing that CBT can be taught to primary care and mental health nurses in England, who can then treat patients] and improve patient outcome even after a brief course of CBT. Outcome measures here included:
Negative symptoms of schizophrenia;
Relapse prevention; and
Insight into the need for treatment, not so much insight into having schizophrenia.
When I learned of this, I thought "aha!" We can use this CBT program as a platform to base a more targeted adherence intervention. CBT, as it is practiced, does not insist on the patient accepting a diagnosis of schizophrenia, does not insist on a medical model. And, it is very patient-centered in the sense that a primary technique in CBT for psychosis is to begin with what bothers the patient -- where is the patient hurting; where is the patient suffering? To develop a formulation or a treatment plan that addresses where the patient is suffering from the patient's point of view.
This sort of approach lines up nicely with my research data that showed that this sort of approach would, theoretically, be very helpful in improving adherence in schizophrenia. In theory, this is very appealing. But, we all know that there is a large gap between theory and practice. But, then we set about to actually see if we could develop such an intervention, and then test that intervention center in Brooklyn, New York.
Medscape: How, then, did you translate recognition of this theory into the practical setting you describe?
Dr. Weiden: Well, we invited Doug Turkington and a colleague of his, Allison Brabban, PhD, Consultant, Clinical Psychologist, Department of Clinical Psychology, Shotley Bridge Hospital, Consett, United Kingdom to spend a week in Brooklyn with us and a group of both senior faculty and front line clinicians including social workers, psychologists, and nurses received and were certified in the CBT approach called CBT Insight Program.
Once we were trained and certified in this program, I then adapted it to target adherence in particular.
Medscape: Can you describe what you mean? What was entailed in adapting the program to target adherence in particular?
Dr. Weiden: It was very important for me to make sure that we did not lose sight of the basic principles of CBT, which include:
Not insisting on a biomedical model; and
Staying with the patient's agenda.
Then I had to merge adherence principles and adherence interventions into this platform. [I] then retrained [faculty and clinicians in the adherence aspects specifically], and we conducted a pilot study where patients who consented to receiving a 12-session CBT program, targeted for adherence, were randomized to psychoeducation and CBT vs psychoeducation alone. We now call this program CBT Adherence Intervention or CBT AI to make sure that people know it is not the exact same intervention as CBT Insight Program developed by Dr. Turkington.
Medscape: What were next steps after the training?
Dr. Weiden: Now, if you want to find patients who are going to stop their medication, one way to do that is to recruit or enroll patients who have recently relapsed with schizophrenia and have just stabilized on medication. I can say that with confidence because a recent relapse and stabilization from relapse winds up being a huge risk factor that predicts nonadherence in the near future.
As I mentioned before, patients who have recently relapsed are 50% to 80% likely to stop their medicine in the near future. By enrolling these individuals and testing this intervention in a randomized pilot study, I knew that we would have high nonadherence rates in the 6-month follow-up period. So, this would be a good test to see whether the intervention of giving patients the 12-session CBT intervention might help reduce nonadherence. We did not think that we would eliminate nonadherence, but if we could just slow it down that would be a [tremendous] advance. Our pilot study [involved] a total of 16 individuals, 9 of whom were randomized to CBT and 7 of whom were randomized to treatment as usual. Just one caveat here -- all of these individuals received standard psychoeducation in group settings. But only the patients randomized to CBT received individual sessions by trained therapists.
Medscape: Can you describe some of the findings?
Dr. Weiden: What we found was very encouraging. We found that the patients who were randomized to the CBT Adherence Intervention stayed on their medication longer. This was [in large part] because virtually all of the patients in the comparison group, the treatment as usual group, had stopped their medication completely within 4 months. While in the CBT intervention group, only about half -- actually, slightly under half -- of the patients stopped. That was a very large difference. Given the small sample size, the trend level was significant, but had a very large effect.
Remember that the theory here is to not force ourselves or our message onto the patient. We were not going to lecture at them or tell them why medicines were "good" for them. We felt that that was not the way to go; [but rather,] if we stayed focused on the patient's agenda and then brought the role of medication into their agenda so that they could explore it and understand it from their own perspective, that would be a success.
Interestingly, it turns out that at the end of the sessions, the CBT intervention group reported to us more reasons why they did not want to take medicine as well as more reasons why they wanted to take medicine.
Medscape: How did that finding affect adherence results or your interpretation of the findings?
Dr. Weiden: Actually, we were very pleased with that because we felt that if patients could verbalize their reluctance or their concerns about medicine, that would help them also understand the potential benefits of medicine in their own terms, as opposed to having it sort of pushed on them, which they would then reject. We found that the patients given this adherence intervention were more likely to take their medicine, but were also more likely to verbalize their concerns and why medicines were not necessarily so terrific which, of course, we all know that antipsychotic medications are not perfect and do not fully treat all of the symptoms. We felt that this ability to verbalize [the pros and cons] was a very healthy step for the [patients], and we were very pleased by that.
Medscape: I imagine that it gives the psychiatrist a chance to address those concerns and, perhaps, make changes.
Dr. Weiden: Well, yes and no. Since we were testing a model, it was very important for us to make sure that the patients given the CBT -- the CBT group -- did not get extra services or more attention from the psychiatrists.
We worked very hard to safeguard that that was not the case that adherence benefits are not because the patients getting the CBT also got more sophisticated psychopharm or more basic services.
But, [your question] does call to mind the very important issue that, when it comes to adherence, there is no one treatment that will work for everyone. If a patient is taking a medicine that does not work for him or her, or is having lots of side effects, the CBT intervention probably will not help adherence. Or, if another patient is so impaired with cognitive problems or with confusion or psychosis that he or she cannot even find their way to the pharmacy to pick up the medicine, I don't think that a therapy where they are talking about goals is going to help necessarily.
One of the things we need to do better as a field is to tailor the specific adherence intervention or the way to help the patient with the actual problem that is making it hard for them to take the medicine.
In this case, we believe that a CBT-based adherence intervention is going to be ideal for a person who:
Rejects "having schizophrenia";
Does not like the idea of a label of mental illness; or
Does not want a biomedical model teaching approach;
but is still willing to engage with someone to talk about what is distressing him or her.
Medscape: Did the clinicians like using this kind of intervention? Were there particular challenges?
Dr. Weiden: That is a very interesting question. If you recall, one thing that we did in this study was to train front line clinicians -- all of whom were superb clinicians -- very good at taking care of very ill patients. But, they were trained in a different type of psychosocial intervention. They were trained in a psychoeducation model, which involves quickly telling patients:
What their symptoms are;
Why medications are needed; and
While this new intervention, [CBT AI] was very much liked by the clinicians, and met with a lot of enthusiasm, the hardest part for them was to allow the patient to describe what they -- the patient -- felt worked or did not work. To allow the patient to describe why medicines were not right for them, or why certain other treatments might work for them, or why they did not want medication. The natural inclination, the knee-jerk reaction by the clinician when a patient is saying something that is clearly "wrong," is to try to correct him or her.
But, in this case, once you try to correct the patient that ends the dialogue.
Medscape: Right; of course.
Dr. Weiden: That part of the training was the hardest. In fact, I would joke around that sometimes our biggest tool for this was a large roll of tape that we kept in the office. Whenever we wanted to tell the patient why they were wrong or why they were thinking about this [in the] wrong [way], look at the tape and imagine yourself putting tape over your mouth so you could then explore further beliefs from the patient's point of view.
The best part is that once we got the hang of it, I think that most of us, including myself and the other clinicians felt that the CBT AI intervention helped us learn a lot more about what was going on with our patients. And at the end of the day, it was a lot more fun for both the clinician and, I presume, the patient. It made the adherence dialogue less painful, less you-vs-me, less of a power struggle and more of a dialogue and collaboration.
We were very pleased with that. In fact, we did, along the way, give a name to this whole process -- the Health Belief Dialogue; Dr. Page Burkholder came up with this name.
We would like to use this name to move away from the medication monologue as a contract. The monologue being the clinician droning on and on and lecturing. We would like to make this a real dialogue, and move it away just from medicine to overall health and health belief; medicine is one part of that. By doing that and by freeing up [the dialogue], we believe that this will help adherence. I say we believe, because I would like to remind the reader that this [viewpoint comes from] a pilot study. And, while we are very encouraged by these results, it was not powered enough to give us a final answer as to whether this technique will really, at the end of the day, prove to be effective in improving adherence and ultimately helping our patients live a better life.
Medscape: It certainly looks promising and it certainly looks as if this is something that should be pursued.
Dr. Weiden: Well, thank you very much, and thank you for giving me the opportunity to explain this to you and your readers.