NCT05710926

Evolutionary Systems Therapy for Schizotypy

A Confirmatory Randomized Controlled Trial Comparing Evolutionary Systems Therapy for Schizotypal Personality Disorder With Cognitive Behavioral Therapy

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 28 (estimated)
• Sponsor: Tages Onlus · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study aims at replicating existing preliminary evidence about the effectiveness of Evolutionary Systems Therapy for Schizotypy (ESTS). The present randomized controlled trial (RCT) will compare ESTS with Cognitive Behavioral Therapy (CBT) in treating Schizotypal Personality Disorder (SPD). The main questions our RCT aims to answer are: 1. Is ESTS more effective than CBT in treating SPD? 2. Is ESTS more feasible than CBT in treating SPD? 38 patients diagnosed with SPD will be recruited and randomly allocated to either the experimental group (i.e. ESTS) or the control group (CBT). Primary outcome will be reduction in general symptomatology, whereas secondary outcomes will be changes in target mechanisms (self-criticism and metacognition) and remission from diagnosis.

Detailed description

A previous study suggested how ESTS (experimental group; EG) may be not inferior in respect to a combine treatment comprising of CBT and psychopharmacological treatment (control group; CG). Despite the encouraging results, it has been suggested that the presence in the CG of a mandatory pharmacological treatment would have represented a bias. Indeed, a few partecipants refused pharmacological treatment. Thus, the investigators outlined an RCT aimed at comparing the two interventions (ESTS and CBT) without any mandatory pharmacological treatment. Moreover, the investigators consider the need for a pharmacological treatment during the study as an exclusion criterion. The investigators expect to extend our knowledge about the feasbility and effectiveness of ESTS for those diagnosed with SPD:

Conditions

• Schizotypal Personality Disorder

Interventions

Type	Name	Description
BEHAVIORAL	Evolutionary Systems Therapy for Schizotypy	A novel therapy for schizotypal traits integrating evolutionary psychopathology, compassion focused therapy, and metacognitively oriented psychotherapy.
BEHAVIORAL	Cognitive Behavioral Therapy	An adaptation of Cognitive Behavioral Therapy for those diagnosed with personaloty disorders.

Timeline

• Start date: 2022-10-05
• Primary completion: 2024-11-01
• Completion: 2025-01-01
• First posted: 2023-02-02
• Last updated: 2023-07-06

Locations

1 site across 1 country: Italy