Antipsychotics, cognitive-behavioral therapy (CBT), and the combination of the two are acceptable, safe, and helpful treatments for people with early psychosis, results of a new study suggest.
The research also indicates that a head-to-head clinical trial of CBT alone vs antipsychotic vs the combination of the two would be feasible and safe in patients who experience a first psychotic episode.
“Our pilot and feasibility trial showed that a methodologically rigorous clinical trial in which participants with psychosis are randomly assigned to psychological treatment or pharmacological treatment, or both, is possible.
“Our findings suggest that antipsychotics, CBT, and the combination of the two are acceptable, safe, and helpful treatments for people with early psychosis, but could have different cost-benefit profiles,” the investigators, led by Anthony Morrison, ClinPsyD, professor of clinical psychology at the University of Manchester, United Kingdom, write.
The study was published online March 28 in Lancet Psychiatry.
CBT a Viable Alternative to Antipsychotics
In an earlier randomized controlled trial, these same investigators found that CBT may be a viable alternative to antipsychotic therapy for patients with established schizophrenia who cannot or will not take an antipsychotic.
In the trial, CBT alone significantly reduced the severity of psychiatric symptoms and improved personal and social functioning and some dimensions of delusional beliefs and voice hearing, as reported by Medscape Medical News.
In this latest study, Morrison and colleagues recruited 75 people aged 16 years and older. Nearly all of the patients had experienced first-episode psychosis and had not received treatment for at least 3 months. Twenty-six were randomly assigned to receive 26 weekly CBT sessions; 24 received varying doses of antipsychotics (as per clinical practice); and 25 underwent antipsychotic therapy plus CBT for 6 months.
The primary outcome was feasibility (recruitment, retention, and acceptability). The primary efficacy outcome was total score on the Positive and Negative Syndrome Scale (PANSS). Patients were assessed at 6, 12, 24, and 52 weeks.
The researchers hit their recruitment target of 75 patients. Attrition was low, and retention was high — only four withdrawals across all groups, which supports the feasibility of conducting such a trial, the researchers say.
Forty (78%) of 51 participants assigned to CBT attended six or more sessions. Of the 49 participants who received antipsychotics, 11 (22%) were not prescribed a regular antipsychotic, they note.
The average baseline PANSS total score in the overall study population was 70.4. At 1 year, the PANSS total score was significantly reduced in the combined antipsychotic/CBT group compared with the CBT-only group (-5.65; 95% confidence interval [CI], -10.37 to -0.93; P = .019).
PANSS total scores did not differ significantly between the combined-treatment group and the antipsychotics group (-4.52; 95% CI, -9.30 to 0.26; P = .064) or between the antipsychotics group and the CBT group (-1.13; 95% CI, -5.81 to 3.55; P = .637).
“However, because this study was a pilot and feasibility trial, it was not powered to reliably detect differences between groups, and any significant differences should be treated with caution,” the researchers note.
Side effects, as measured by the Antipsychotic Non-Neurological Side Effects Rating Scale (ANNSERS), were significantly less common in the CBT group than in the antipsychotics group (P = .017) or the combined intervention group (P = .003). The difference in side effects between the combined group and the antipsychotics group was not significant.
What is needed now, they add, is an adequately powered efficacy and effectiveness trial to test hypotheses about superiority (eg, antipsychotics plus CBT vs antipsychotics alone or CBT alone) and noninferiority (eg, antipsychotics vs CBT).
For now, the investigators report that it is “reasonable to support people with psychosis (who do not present immediate risk to themselves or others) to make informed choices as outlined in the National Institute for Health and Care Excellence guidelines, which recommend advising people who want to try psychological interventions alone that such interventions are more effective when delivered in conjunction with antipsychotic medication, but allowing them to try family intervention and CBT without antipsychotics while agreeing a time to review treatment options, including introduction of antipsychotics.”
A Paradigm Shift
Sameer Jauhar, MCChB, MRCPsych, of the Institute of Psychiatry, Psychology and Neuroscience, King’s College London, United Kingdom, agrees that more well-designed controlled clinical trials are needed.
“For people with first-onset psychosis who have significant symptoms not to be offered antipsychotic treatment would be thought to be a Kuhnian paradigm shift by some psychiatric health professionals,” Jauhar writes in a linked comment.
“Reduction of the duration of untreated psychosis was one of the drivers behind the introduction of services for first-episode psychosis, in which antipsychotics are the cornerstone of early intervention before formalized psychosocial interventions. Therefore, any alternative approaches would need a solid evidence base for a larger trial to be considered,” Jauhar concludes.
The study was funded by the UK National Institute for Health Research. Dr Morrison delivers training workshops and has written textbooks about CBT for psychosis, for which he receives fees; has conducted funded research on CBT for psychosis; and delivers CBT in the National Health Service. The original article provides a complete listing of author disclosures. Dr Jauhar has disclosed no relevant financial relationships.
Lancet Psychiatry. Published online March 28, 2018. Abstract, Comment
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