An important study, published in the prestigious British medical journal Lancet, was headlined on MIA this week. The study examined the effectiveness of cognitive behavioral therapy (CBT) to treat the symptoms of people labeled with a diagnosis of schizophrenia and related conditions who had elected to not take neuroleptic drugs. The study found that those who were in therapy had a modest improvement as compared to those who received “treatment as usual (TAU)”, meaning the other types of services available in their clinic. The study was conducted by a group who have been pioneers in this work for the past two decades.
In two different clinics, they compared two groups of 37 individuals who were experiencing psychotic symptoms and were not taking neuroleptic drugs. One group received TAU and the other group received CBT and TAU. Those in CBT were offered weekly sessions for up to 9 months and then received up to 4 additional sessions over the next 9 months.
The primary outcome measure was the Positive and Negative Symptoms Scale (PANSS), which was completed by a rater who did not know the treatment assignment. People were assessed at every three months through the first year and then at 15 and 18 months. This is considered a “single blind”- the person in the study knows if she has participated in CBT but the rater does not. They also collected data on the Psychotic Symptoms Rating Scale, a recovery rating scale, a scale of personal and social performance, and measures of depression and anxiety.
The baseline PANSS was about 70, which is considered to be moderately ill. In recent drug studies that I have reviewed, typical initial PANSS scores are about 90, so this group would not be considered to be as ill.
At 18 months, there were advantages for CBT. There was improvement in so-called positive symptoms (hearing voices, delusional ideas) but not for negative symptoms (apathy, withdrawal). The effects were considered small to moderate but on par with effect sizes in recent studies of neuroleptic drugs.
At 18 months, 7 of 17 (41%) in the CBT group and 3 of 17 (18%) in the TAU group experienced greater than 50% improvement in PANSS total score. It is interesting that in the Wunderink Study, there was a 40% rate of recovery in the group who had intermittent drug treatment. Two individuals in each group experienced a 50% increase in PANSS scores during this time. (The numbers are lower at 18 months because not everyone was in the study for that duration; some had dropped out but others just enrolled later and were only followed for 9 months).
There were drop outs but it is notable that many people were willing to engage; about 50% of those referred ended up enrolling in the study. The average number of sessions was 13.2 with a range of 2-26. The authors also note that, overall, there was improvement in both groups although some people did not do well and there were people who fell out of treatment. About 20% of those in each group started on neuroleptic drugs during the study, but there were equal numbers in each group and this did not appear to impact outcome.
The main points they made were: this is not dangerous, this may help some people, this is an approach that should be offered. Many people choose to not take drugs and many stop them. With increasing evidence that these drugs contribute to worse outcomes, it seems imperative to offer alternatives. They acknowledge that this is a pilot study and they urge replication on a larger scale.
The accompanying editorial points out – as do the authors – that there was no placebo comparison group so we do not know if it was the specific effects of the CBT that had the greatest impact or the effect of having regular meetings with a caring, empathic person.
Not too long ago, I had a conversation with a senior researcher. I asked if he agreed – given the many problems associated with the neuroleptics – that we should be doing everything we can to identify those individuals who might get better without taking the drugs. His response was that this could never be studied. No IRB would ever approve a study.
A commentary published in Science Magazine, asked “Is It Time to Flush the Drugs?” This is not the question I would ask.
My questions are, “Is it OK to offer people alternatives?” or “Is it OK to wait before starting drugs?” or “Is it helpful to talk to people about their experiences?”
The accompanying editorial calls this study a “proof of concept” study. The concept is that cognitive therapy is an alternative to drugs. Yes, this is a small study. Yes, it should be repeated. My own thought is that the conditions and experiences that we label as psychotic are so highly variable, that there is unlikely to be one approach that will be helpful to everyone. I am drawn to the fundamental concepts encompassed by the Needs Adapted Approach. Start with the problem as the individual defines it. Engagement is everything. If someone does not talk to you it hardly matters what treatment you have to offer. That is where we start.
But at the next step, there are choices.
The paradigm is shifting.
