"Schizophrenia: Talking therapies 'effective as drugs'," reports BBC News. But this headline is in fact arguably misleading. The BBC reports on a new study comparing the use of cognitive therapy (CT) with no treatment in people with schizophrenia (or more precisely, schizophrenia spectrum disorders).
Antipsychotic drugs are a widely used treatment for schizophrenia. But many people with the condition stop taking the drugs, either because they do not help with symptoms or they cannot tolerate the side effects. These can include weight gain and drowsiness.
This study was a randomised controlled trial (RCT) of 74 people with schizophrenia who were no longer taking antipsychotics. Participants were allocated to either receive CT for up to nine months or "treatment as usual". CT is a type of talking therapy that aims to promote more positive and useful patterns of thinking and behaviour.
Symptoms were assessed using a recognised rating scale before treatment, and then every three months for 18 months. The researchers found a small but significant improvement in symptoms with CT.
However, conclusions are limited, as one-fifth of the participants in each group had started to take antipsychotic medication during the trial, and a third of each group dropped out.
This study adds to a body of previous research, which has shown that CT can lead to small improvements in symptoms and social function for people with schizophrenia spectrum disorders. However, it did not directly compare talking treatments with the use of antipsychotic medication.
If you are taking medication for a schizophrenia spectrum disorder, it is important that you do not suddenly stop taking your drugs. Discuss any concerns you might have with your key worker or psychiatrist.
Where did the story come from?
The study was carried out by researchers from the universities and NHS mental health trusts of Manchester and Newcastle-upon-Tyne, and was funded by the National Institute for Health Research.
It was published in the peer-reviewed medical journal, The Lancet.
The study was reliably reported by BBC News, although the headline was misleading.
The study showed that CT can be effective in improving symptoms of schizophrenia, but it did not compare the therapy with any antipsychotic medication. It could be the case that some people with schizophrenia would benefit from a combination of CT and antipsychotics.
What kind of research was this?
This was a randomised controlled trial (RCT) of people with schizophrenia who did not wish to take antipsychotic medication. This can be for a number of reasons, including lack of insight into their condition or side effects such as weight gain, restlessness and an increased risk of type 2 diabetes. The study aimed to see if CT was effective in improving the symptoms of schizophrenia.
An RCT is the ideal study design to prove cause and effect, but ideally it should be double-blinded, where the participant and assessing doctor do not know which treatment the participant is having. This reduces the possibility of bias.
This study had to be single-blind (the assessors did not know which people had received CT) because the participants would know if they had received a talking therapy or not.
What did the research involve?
Researchers randomly assigned 74 participants to receive either "treatment as usual" or CT, and assessed their symptoms before the treatment and regularly for 18 months.
Treatment as usual depended on the diagnosis, stage of illness and local services. It could involve seeing a psychiatrist and key worker, such as a community psychiatric nurse, psychiatric social worker or occupational therapist, or a combination of the two. CT involved 26 sessions offered once a week over a maximum of nine months, plus up to four booster sessions over the next nine months.
Symptoms were assessed by research assistants who did not know which treatment group the person was in. They used an internationally recognised rating system called the Positive and Negative Syndrome Scale (PANSS) before treatment, and afterwards at three, six, nine, 12, 15 and 18 months.
PANSS scores 30 symptoms on a scale of one to seven, with one meaning the symptom is absent and seven extreme. Positive symptoms include delusions, excitement and hostility. Negative symptoms include difficulty feeling emotions, social withdrawal and lack of spontaneity. Other general symptoms include poor attention, lack of insight and disorientation.
Several other secondary assessments were also used, including the Beck Depression Inventory and the Social Interaction Anxiety Scale.
Participants were eligible for the study if they had:
- a diagnosis of schizophrenia, schizoaffective disorder or delusional disorder, or were in the early phases of a first episode of psychosis
- continuing positive symptoms of delusions or hallucinations of at least four (moderate) on the PANSS, or at least five (moderate/severe) for suspiciousness or feelings of persecution, conceptual disorganisation (difficulty thinking clearly) or grandiosity (an unrealistic sense of superiority)
People were excluded from the study if they had:
- been taking antipsychotic medication during the six months before the study started
- a moderate to severe learning disability, brain disease (such as dementia) or brain damage
- lack of capacity to consent to the study
- a main diagnosis of substance or alcohol abuse
- were currently in hospital
What were the basic results?
At the beginning of the study, the average (mean) total PANSS score for the CT group was 70.24, compared with 73.27 for the treatment as usual group (scale of 30 to 210), which indicates moderate illness.
The estimate of the improvement in total PANSS score with CT was -6.52 (95% confidence interval [CI]: -10.79 to -2.25) compared with the treatment as usual group.
A very small improvement in overall positive symptoms of -2.22 (95% CI: -4.00 to -0.44) and overall general symptoms of -3.63 (95% CI -5.99 to -1.27) was seen, but not on negative symptoms.
The researchers report that, "Therapy did not significantly affect the amount of distress associated with delusional beliefs or voice hearing, or levels of depression, social anxiety and self-rated recovery".
Nine of the 37 patients assigned to CT discontinued the therapy in the first three months, increasing to 12 by six months, which was similar to the number of people who stopped contact with mental health services in the treatment as usual group.
There were eight serious adverse events:
- in the CT group, one participant attempted overdose and another became a risk to others after treatment
- in the treatment as usual group, one participant attempted overdose, three participants were admitted to hospital under the Mental Health Act, and two participants died, although the deaths were deemed to be unrelated to mental health
Ten participants in each group took antipsychotic medication during the study and some also took antidepressants.
How did the researchers interpret the results?
The researchers conclude that the "findings suggest that cognitive therapy is an acceptable, safe and effective treatment alternative for people who choose not to take antipsychotics.
"Evidence-based treatments should be available to these people. A larger definitive trial is needed to confirm the clinical implications of our pilot study."
This study provides some evidence that cognitive therapy (CT) may be helpful for some people with a schizophrenia spectrum disorder. However, the benefits seen – as measured on the rating scale (PANSS) – are small.
The study design has strengths in that it attempted to blind the assessors as to which treatment the participants were receiving. It also recruited participants who did not want to take antipsychotic medication and had not done so for six months before the study.
However, 10 people in each group did take antipsychotics during the trial. This complicates the results, as it is not clear whether the improvements were as a result of the CT, the medication or a combination of both.
A further point that the researchers raise is that it is not clear whether the specific type of talking therapy is important, or whether the contact time, warmth and empathy that was received in the CT group was the factor that made the difference.
Schizophrenia spectrum disorders cover a wide range of symptoms and each person has a different individual experience of their illness. This study contributes to previous research, which has shown that CT can be beneficial for people with the condition.
However, importantly, it does not show that it is better or equivalent to antipsychotic medication. The participants continued to have moderate levels of illness despite receiving therapy.
If you are taking medication for a schizophrenia spectrum disorder, it is important that you do not suddenly stop. Doing so could lead to a sudden worsening of your symptoms. Tell your care co-ordinator or GP if your side effects become severe. There may be an alternative antipsychotic you can take or additional medicines that will help you deal with the side effects.
Analysis by Bazian
Edited by NHS Website
Links to the headlines
BBC News, 6 February 2014
Links to the science
The Lancet. Published online February 6 2014