New CBT programme may help manage persecutory delusions

The Feeling Safe Programme (FSP) – a new, modular, personalized, theoretically driven cognitive behavioural therapy (CBT) programme – led to a significant reduction in persistent persecutory delusions compared with befriending, a UK study suggests.

“We focused on persecutory delusions [owing to evidence indicating] that it is a distinct delusion type … associated with very low psychological wellbeing, and occurs in >70 percent of patients who present with nonaffective psychosis,” said the researchers.

Despite evidence reflecting the benefit of CBT for delusions, most studies are small. “There is a large clinical need for improved treatments for patients with persecutory delusions … The FSP could become the recommended psychological treatment in clinical services for persecutory delusions,” said the researchers.

A hundred and thirty participants (mean age 42 years, 60 percent male) were randomized 1:1 to undergo either the FSP or the befriending programme. The prevailing diagnosis was schizophrenia. A majority of participants received antipsychotic medication. [Lancet Psychiatry 2021;8:696-707]

At baseline, 41 participants rated their degree of conviction in the delusional belief as 100 percent, while 122 rated their delusion conviction as ≥70 percent. Baseline PSYRATS* scores indicate a high severity of persecutory delusions.

At 6 months, significant mean differences were observed in favour of FSP over befriending, in terms of delusional conviction (–10.69; p=0.021) and delusion severity (PSYRATS; –2.94; p<0.0001), as well as other secondary endpoints (–5.59; p=0.032 [overall paranoia], –1.45; p=0.016 [anger], and –2.39; p=0.021 [ideas of reference]).

Psychological wellbeing (mean difference, 5.09; p<0.0001), patient satisfaction (7.92; p=0.010), activity (5.03; p=0.016), and quality of life (0.07; p=0.027) also improved significantly better with FSP vs befriending.

“Overall, there were large effects of the FSP on persecutory delusions, but the size of significant changes in other measures that occurred were typically more modest,” the researchers noted. “The gains made by the FSP participants persisted at 12 months … [However, due to] a slightly lower number of patients followed up at this later timepoint and slight fluctuations in scores, not all the previous differences remained significant.”

Other variables that improved with the FSP vs befriending are the possibility of being mistaken, positive beliefs about others, and insomnia (mean differences, 13.92, 2.24, and –2.98, respectively; p=0.002 for all), as well as vulnerability beliefs (–12.67; p=0.007), negative self-beliefs (–1.63; p=0.038), and worry (–3.33; p=0.046).

“Both the FSP and befriending were taken up by patients to a very high degree and were associated with clinical improvement,” said the researchers. “[However, FSP] led to large clinical changes in persecutory delusions that were greater than the non-specific relationship benefits of befriending … The FSP treatment gains were largely maintained over time … principally in the specific targeted outcome,” said the researchers.

“[T]hese results show that if a proven theoretical model is translated into focused intervention techniques that are implemented intensively – within an intervention framework that explicitly addresses the multifactorial complexity of causation in psychosis and patient preference – then major improvements in treatment outcomes are possible,” they continued.

Despite the largest treatment effects, the small population could have limited the comparison between the two active treatments, they noted. Further exploration is thus necessary to ascertain the possibility of seeing greater effects. “[While] the theoretical model has been translated into efficacious treatment … [we believe] the treatment could be improved further by achieving greater traction on the mechanisms.”