By Reuters Staff
NEW YORK (Reuters Health) - A novel, theoretically driven cognitive behavior therapy (CBT) called the Feeling Safe program led to large reductions in persecutory delusions in a small randomized controlled trial from the U.K.
With confirmatory studies, the Feeling Safe program "could become the recommended psychological treatment in clinical services for persecutory delusions," write Dr. Daniel Freeman of the University of Oxford and colleagues in The Lancet Psychiatry.
Persecutory delusions are unfounded, strong beliefs that other people intend you harm. CBT for psychosis (CBTp) is recommended as an evidence-based adjunct to medication for persecutory delusions. However, the effect size of CBTp on delusions is small (approximately Cohen's d=0.3), the authors note.
The Feeling Safe program was designed as a more personalized, translational treatment that helps patients develop new memories of safety and address the factors that often maintain persecutory thoughts (https://bit.ly/2W7kKNf).
In a parallel, single-blind, randomized study, Dr. Freeman and colleagues tested the Feeling Safe program against befriending with the same therapists in 130 patients with persistent persecutory delusions in the context of non-affective psychosis. Each treatment was provided individually in approximately 20 sessions over six months using the same nine psychologists.
The end-of-treatment recovery rate from delusions was 50.8% in the Feeling Safe group, which was not significantly higher than the 34.9% recovery rate in the befriending group (P=0.067).
At six and 12 months, there was a 50% reduction in delusion severity in 32.8% of patients in the Feeling Safe group versus 13.6% (P=0.019) at six months and 15.2% (P=0.031) at 12 months for those in the befriending group.
The researchers say that, to their knowledge, the Feeling Safe program produced "the largest treatment effects seen for patients with persistent delusions" to date, with Cohen's d effect sizes of 0.86 for delusional conviction and of 1.2 for delusion severity.
Compared with befriending, Feeling Safe also led to significant reductions in overall paranoia and anger and significant improvements in psychological wellbeing, patient satisfaction and quality of life.
The chief limitation of the trial is the small sample size when comparing two active treatments. The trial was done in one center, and there were few people from ethnic minority groups.
"Our study provides grounds for both a multicenter trial and for further refinement of the intervention methods," Dr. Freeman and colleagues say.
In a linked editorial, Dr. Eiko Fried of the Institute of Psychology at Leiden University, in the Netherlands, and colleagues note that the difference between Feeling Safe and befriending was "moderate in terms of clinical significance, and the pattern of efficacy differences is consistent with the programs aims: Feeling Safe affected positive symptoms, but also anger, psychological wellbeing, and other important outcomes, which in turn might help to reduce paranoia."
While the program's short-term results "appear nothing but substantial, long-term follow-up of patients will be required to assess prognosis," they write. It also "remains to be seen whether the large effect sizes for either group will replicate in real-world settings with less specialized and trained therapists,"
SOURCE: https://bit.ly/2TtOnHy and https://bit.ly/3kR4GcP Lancet Psychiatry, online July 8, 2021.