Antipsychotic drugs v CBT versus a combination of both in people with psychosis: rc pilot & feasibility study, Morrison et al, 2018

Indigophoton · Mar 30, 2018

Summarised by Keith Laws, Prof of Cognitive Neuropsychology, as showing that,

https://twitter.com/user/status/979431898496806912

Abstract:

Background
Little evidence is available for head-to-head comparisons of psychosocial interventions and pharmacological interventions in psychosis. We aimed to establish whether a randomised controlled trial of cognitive behavioural therapy (CBT) versus antipsychotic drugs versus a combination of both would be feasible in people with psychosis.

Methods
We did a single-site, single-blind pilot randomised controlled trial in people with psychosis who used services in National Health Service trusts across Greater Manchester, UK. Eligible participants were aged 16 years or older; met ICD-10 criteria for schizophrenia, schizoaffective disorder, or delusional disorder, or met the entry criteria for an early intervention for psychosis service; were in contact with mental health services, under the care of a consultant psychiatrist; scored at least 4 on delusions or hallucinations items, or at least 5 on suspiciousness, persecution, or grandiosity items on the Positive and Negative Syndrome Scale (PANSS); had capacity to consent; and were help-seeking. Participants were assigned (1:1:1) to antipsychotics, CBT, or antipsychotics plus CBT. Randomisation was done via a secure web-based randomisation system (Sealed Envelope), with randomised permuted blocks of 4 and 6, stratified by gender and first episode status. CBT incorporated up to 26 sessions over 6 months plus up to four booster sessions. Choice and dose of antipsychotic were at the discretion of the treating consultant. Participants were followed up for 1 year. The primary outcome was feasibility (ie, data about recruitment, retention, and acceptability), and the primary efficacy outcome was the PANSS total score (assessed at baseline, 6, 12, 24, and 52 weeks). Non-neurological side-effects were assessed systemically with the Antipsychotic Non-neurological Side Effects Rating Scale. Primary analyses were done by intention to treat; safety analyses were done on an as-treated basis. The study was prospectively registered with ISRCTN, number ISRCTN06022197.

Findings
Of 138 patients referred to the study, 75 were recruited and randomly assigned—26 to CBT, 24 to antipsychotics, and 25 to antipsychotics plus CBT. Attrition was low, and retention high, with only four withdrawals across all groups. 40 (78%) of 51 participants allocated to CBT attended six or more sessions. Of the 49 participants randomised to antipsychotics, 11 (22%) were not prescribed a regular antipsychotic. Median duration of total antipsychotic treatment was 44·5 weeks (IQR 26–51). PANSS total score was significantly reduced in the combined intervention group compared with the CBT group (–5·65 [95% CI −10·37 to −0·93]; p=0·019). PANSS total scores did not differ significantly between the combined group and the antipsychotics group (–4·52 [95% CI −9·30 to 0·26]; p=0·064) or between the antipsychotics and CBT groups (–1·13 [95% CI −5·81 to 3·55]; p=0·637). Significantly fewer side-effects, as measured with the Antipsychotic Non-neurological Side Effects Rating Scale, were noted in the CBT group than in the antipsychotics (3·22 [95% CI 0·58 to 5·87]; p=0·017) or antipsychotics plus CBT (3·99 [95% CI 1·36 to 6·64]; p=0·003) groups. Only one serious adverse event was thought to be related to the trial (an overdose of three paracetamol tablets in the CBT group).

Interpretation
A head-to-head clinical trial of CBT versus antipsychotics versus the combination of the two is feasible and safe in people with first-episode psychosis.
Click to expand...

http://www.thelancet.com/journals/lanpsy/article/PIIS2215-0366(18)30096-8/fulltext

Jonathan Edwards · Mar 30, 2018

This is interesting but I don't think anyone should expect CBT to be any good in schizophrenia. CBT depends on persuading the person with rational arguments about ways to improve their health. In psychosis rationality has been lost so there is no reason to think CBT is relevant. At least it is good to see that someone seems to want to show this formally.

Antipsychotic drugs aren't much cop either to be honest but for some people they do seem to work.

Hoopoe · Mar 30, 2018

Jonathan Edwards said: ↑

This is interesting but I don't think anyone should expect CBT to be any good in schizophrenia. CBT depends on persuading the person with rational arguments about ways to improve their health. In psychosis rationality has been lost so there is no reason to think CBT is relevant. At least it is good to see that someone seems to want to show this formally.
Click to expand...

Someone seems to think this confirms CBT is better than medication.

https://twitter.com/user/status/979261319726714881

I have not read more than a few lines from this article and it's interesting that two opposed and incompatible interpretations are being made, much like in the PACE trial.

Jonathan Edwards · Mar 30, 2018

strategist said: ↑

I have not read more than a few lines from this article and it's interesting that there two opposed and incompatible interpretations are being made, much like in the PACE trial.
Click to expand...

No surprises then?

adambeyoncelowe · Mar 30, 2018

From that classic of modern culture, The Abyss (and Don Miguel Ruiz before that): 'We all see what we want to see.'

Londinium · Mar 30, 2018

strategist said: ↑

Someone seems to think this confirms CBT is better than medication.

https://twitter.com/user/status/979261319726714881

I have not read more than a few lines from this article and it's interesting that two opposed and incompatible interpretations are being made, much like in the PACE trial.
Click to expand...

I think they're arguing that CBT+meds is better than meds. Looking at the results, the study suggests that's the case but the effect is not strong enough to meet the standard p<0.05 cut off:

Meds+CBT > CBT (p<0.02)

Meds+CBT > Meds (p=0.06, 95% confidence interval does include possibility of nil effect)

Meds > CBT (p=0.64) --> impossible to draw a conclusion on comparing the effectiveness of the two.

Prof Laws is right that Meds added to CBT improves the latter but not the other way round, if one applies a strict p=0.05 cut off. But I think taking less absolutist view of that threshold would indicate that combined therapy is better than either one alone.

Adrian · Mar 30, 2018

It looks like a feasibility study to see if they could do a trial with 26 patients in one arm and 24 in the other. So may be too underpowered to show a significant difference. Also subjective outcomes (possibly judged by a doctor with a 45 minute interview).

Sid · Mar 31, 2018

The mere notion that CBT could or should be used in a disorder as serious and impervious to rational argumentation as psychosis is pretty disturbing IMO and what is even more disturbing is that ethics committees nowadays are permitting this sort of "research". Funny how so many psych trials are like a Rorschach inkblot: each side "sees" results are supporting their side.

Indigophoton · Mar 31, 2018

https://twitter.com/user/status/980000246024556544

Amw66 · Mar 31, 2018

https://twitter.com/user/status/980097696517312513

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