Evolutionary Systems Therapy for Schizotypy (ESTS-RCT)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Schizotypal Personality Disorder
• Intervention / Treatment: Behavioral: Cognitive Behavioral Therapy; Behavioral: Evolutionary Systems Therapy for Schizotypy

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:

• Study Type: Interventional
• Enrollment (Estimated): 28
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Simone Cheli, PhD; Phone Number: +393285642442; Email: simone.cheli@tagesonlus.org
• Study Contact Backup: Name: Marta Floridi, PsyD; Phone Number: +39055679037; Email: marta.floridi@tagesonlus.org

Study Locations

• Italy
  • FI
    • Firenze, FI, Italy, 50137
      • Recruiting
      • Centro di Psicologia e Psicoterapia Tages Onlus - Firenze
      • Principal Investigator: Simone Cheli, PhD
      • Sub-Investigator: Gil Goldzweig, PhD
      • Contact: Veronica Cavalletti; Phone Number: +39 055 679037; Email: veronica.cavalletti@tagesonlus.org
      • Contact: Marta Floridi; Email: marta.floridi@tagesonlus.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Behavioral: Cognitive Behavioral Therapy; An adaptation of Cognitive Behavioral Therapy for those diagnosed with personaloty disorders.
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.	Behavioral: Evolutionary Systems Therapy for Schizotypy; A novel therapy for schizotypal traits integrating evolutionary psychopathology, compassion focused therapy, and metacognitively oriented psychotherapy.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Tages Onlus
• Investigators: Principal Investigator: Simone Cheli, PhD, Tages Onlus

Study record dates

Study Major Dates

• Study Start (Actual): October 5, 2022
• Primary Completion (Estimated): November 1, 2024
• Study Completion (Estimated): January 1, 2025

Study Registration Dates

• First Submitted: January 17, 2023
• First Submitted That Met QC Criteria: January 25, 2023
• First Posted (Actual): February 2, 2023

Study Record Updates

• Last Update Posted (Actual): July 6, 2023
• Last Update Submitted That Met QC Criteria: July 5, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: metacognition; personality disorder; compassion; schizotypy
• Additional Relevant MeSH Terms: Mental Disorders; Personality Disorders; Schizotypal Personality Disorder
• Other Study ID Numbers: ESTS-23

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will be anonymized and shared through Open Science Foundation at the end of the study.
• IPD Sharing Time Frame: Study protocol, SAP, and ICF will be shared before the end of February 2023.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No