Cognitive therapy program reduces persistent delusions in non-affective psychosis

A theoretically driven cognitive therapy program significantly reduced persistent persecutory delusions compared with a befriending intervention among patients with non-affective psychosis.

Researchers reported these results in a parallel, single-blind, randomized controlled trial published in The Lancet Psychiatry.

“Too many people with severe paranoia have their fears persist despite current treatments,” Daniel Freeman, PhD, DClinPsy, of the department of psychiatry at the University of Oxford in the U.K., told Healio Psychiatry. “They feel very unsafe. and consequently people withdraw from everyday life, which is bad for both mental and physical health. Our step change target in outcomes was that we can achieve recovery in half of persecutory delusions that have remained despite treatment with antipsychotic medication.”

Freeman and colleagues tested the Feeling Safe Program, which allowed patients to choose modules identified via assessment as being relevant to them, against a befriending intervention with the same therapists for patients with persistent persecutory delusions in the context of diagnoses of non-affective psychosis. Participants continued to receive usual care throughout the duration of the trial, which occurred across community mental health services in three U.K. National Health Service trusts. Between Feb. 8, 2016, and July 26, 2019, the researchers recruited 130 participants (60% men; mean age, 42 years; 86% white) aged 16 years or older who had persecutory delusions for 3 months or longer that held with at least 60% conviction, with a primary diagnosis of non-affective psychosis from the referring clinical team. They randomly assigned 64 patients to the Feeling Safe Program and 66 patients to the befriending program via a permuted blocks algorithm with randomly varying block size, which they stratified by therapist. Outcome assessments occurred at 0, 6 and 12 months, with persecutory delusion conviction assessed via the Psychotic Symptoms Rating Scale serving as the primary outcome. The researchers conducted outcomes analyses among the intention-to-treat population.

Results showed significant end of treatment reductions in delusional conviction of –10·69 (95% CI, –19·75 to –1·63) and delusion severity of –2·94 (95% CI, –4.58 to –1.31) for the Feeling Safe Program compared with befriending. The befriending group had 68 unrelated adverse events among 20 participants compared with 53 unrelated adverse events among 16 participants in the Feeling Safe group.

“Patients were significantly happier after receiving the Feeling Safe Program, which was a popular treatment with high take up rates,” Freeman said. “Almost the same percentage of patients remained recovered in the persecutory delusions at the later follow-up. The type of therapy received really does matter, and the Feeling Safe Program is the most effective psychological treatment for severe paranoia.”

In a related editorial, Eiko I Fried, PhD, of the Institute of Psychology at Leiden University in the Netherlands, and colleagues highlighted remaining questions in this area of study.

“The Feeling Safe [Program] is a well conducted study, but it remains to be seen whether the large effect sizes for either group will replicate in real-world settings with less specialized and trained therapists, and whether the large effect size for the Feeling Safe [Program] versus befriending will replicate when no ceiling effects are present that impact effect size calculation,” they wrote.