Evolutionary Systems Therapy for Schizotypy

Schizotypal Personality Disorder Clinical Trial

— ESTS-RCT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05710926
• Other study ID #: ESTS-23
• Status: Recruiting
• Phase: N/A
• Start date: October 5, 2022
• Est. completion date: January 1, 2025

Study information

• Verified date: July 2023
• Source: Tages Onlus
• Contact: Simone Cheli, PhD
• Phone: +393285642442
• Email: simone.cheli[@]tagesonlus.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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:

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 28
• Est. completion date: January 1, 2025
• Est. primary completion date: November 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Personality Disorders
• Schizotypal Personality Disorder

Intervention

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

Locations

Country	Name	City	State
Italy	Centro di Psicologia e Psicoterapia Tages Onlus - Firenze	Firenze	FI

Sponsors (1)

Lead Sponsor	Collaborator
Tages Onlus

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)