A pilot randomized controlled trial comparing a novel compassion and metacognition approach for schizotypal personality disorder with a combination of cognitive therapy and psychopharmacological treatment

Background: Schizotypal personality disorder is characterized by a pervasive pattern of maladaptive behavior that has been associated with the liability for schizophrenia. Little is known about effective psychosocial interventions. This pilot non-inferiority randomized controlled trial aimed to compare a novel form of psychotherapy tailored for this disorder and a combination of cognitive therapy and psychopharmacological treatment. The former treatment - namely, Evolutionary Systems Therapy for Schizotypy-integrated evolutionary, metacognitively oriented, and compassion focused approaches.

Methods: Thirty-three participants were assessed for eligibility, twenty-four randomized on a 1:1 ratio, nineteen included in the final analysis. The treatments lasted 6 months (24 sessions). The primary outcome was change across nine measurements in personality pathology, the secondary outcomes were remission from diagnosis and pre-post changes in general symptomatology and metacognition.

Results: Primary outcome suggested a non-inferiority of the experimental treatment in respect to control condition. Secondary outcomes reported mixed results. There was no significant difference in terms of remission, but experimental treatment showed a larger reduction of general symptomatology (η² = 0.558) and a larger increase in metacognition (η² = 0.734).

Conclusions: This pilot study reported promising results about the effectiveness of the proposed novel approach. A confirmatory trial on large sample size is needed to provide evidence about relative effectiveness of the two treatment conditions.

Trial registration: ClinicalTrials.gov; NCT04764708; Registration day 21/02/2021.