Evolutionary Systems Therapy for Schizotypy

Overview

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.

Full Title of Study: “A Confirmatory Randomized Controlled Trial Comparing Evolutionary Systems Therapy for Schizotypal Personality Disorder With Cognitive Behavioral Therapy”

Study Type

• Study Type: Interventional
• Study Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Primary Purpose: Treatment
  • Masking: Double (Investigator, Outcomes Assessor)
• Study Primary Completion Date: November 1, 2024

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:

Interventions

• 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.

Arms, Groups and Cohorts

• Active Comparator: Cognitive Behavioral Therapy
  • Cognitive Behavioral Therapy for Personality Disorder as manualized by Beck, Davis, Freeman and Beck in their book (2016) will be delivered to partecipants in the active control group.
• Experimental: Evolutionary Systems Therapy for Schizotypy
  • Evolutionary Systems Therapy for Schizotypy as manualized by Cheli and colleagues in their trial (2023) will be delivered to partecipants in the experimental group.

Clinical Trial Outcome Measures

Primary Measures

• Change in general symptomatology
  • Time Frame: 2 measurements: one at baseline assessment; one at final assessment
  • Change in the total score of Symptom Checklist-90-R (SCL-90-R) between two measurements

Secondary Measures

• Change in metacognition
  • Time Frame: 2 measurements: one at baseline assessment (once the intervention starts); one at final assessment (6 months after, that is after weekly scheduled 24 sessions)
  • Change in total score of Metacognition Assessment Scale – Abbreviated (MAS-A) between two measurements
• Change in critical beliefs about self
  • Time Frame: 2 measurements: one at baseline assessment (once the intervention starts); one at final assessment (6 months after, that is after weekly scheduled 24 sessions)
  • Change in the Hated-self scale of The Forms of Self-Criticizing/attacking and Self-reassuring Scale (FSCRS) between two measurements
• Change in critical beliefs about others
  • Time Frame: 2 measurements: one at baseline assessment (once the intervention starts); one at final assessment (6 months after, that is after weekly scheduled 24 sessions)
  • Change in Socially prescribed perfectionism scale of Multidimensional Perfectionism Scale (MPS) between two measurements
• Change in schizotypal traits 1
  • Time Frame: 2 measurements: one at baseline assessment (once the intervention starts); one at final assessment (6 months after, that is after weekly scheduled 24 sessions)
  • Change in Psychoticism scale of Personality Inventory for DSM-5 (PID-5) between two measurements
• Change in schizotypal traits 2
  • Time Frame: 2 measurements: one at baseline assessment (once the intervention starts); one at final assessment (6 months after, that is after weekly scheduled 24 sessions)
  • Change in Detachment scale of Personality Inventory for DSM-5 (PID-5) between two measurements
• Change in remission from primary diagnosis
  • Time Frame: 2 measurements: one at baseline assessment (once the intervention starts); one at final assessment (6 months after, that is after weekly scheduled 24 sessions)
  • Change in Diagnosis of Schizotypal Personality Disorders trough Structured Clinical Interview for the DSM-5 Alternative Model for Personality Disorders (SCID-5-AMPD) Module III between two measurements

Participating in This Clinical Trial

Inclusion Criteria

• Diagnosis of Schizotypal Personality Disorder at SCID-5-AMPD Module III – Age 18 or older – Being capable of reading and signing the inform consent form in Italian – Being capable of attending a talk therapy in Italian Exclusion Criteria:

• Being diagnosed with schizophrenia spectrum disorders or other psychosis disorder – Being diagnosed with neurodevelopmental or neurological disorders – Being diagnosed with bipolar disorder – Being under any psychological or pharmacological treatment

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

• Lead Sponsor
  • Tages Onlus
• Provider of Information About this Clinical Study
  • Sponsor
• Overall Contact(s)
  • Simone Cheli, PhD, +393285642442, simone.cheli@tagesonlus.org