Evolutionary Systems Therapy for Schizotypy

Not Applicable

Recruiting

• Conditions: Schizotypal Personality Disorder
• Interventions: Behavioral: Cognitive Behavioral Therapy; Behavioral: Evolutionary Systems Therapy for Schizotypy

• Registration Number: NCT05710926
• Lead Sponsor: Tages Onlus

Brief 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:

Study Timeline

• Study Start: 2022-10-05
• Study First Submitted: 2023-01-17
• Study First Submitted QC: 2023-01-25
• Study First Posted: 2023-02-02
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-05
• Last Update Posted: 2023-07-06
• Primary Completion: 2024-11-01
• Study Completion: 2025-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 28

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cognitive Behavioral Therapy	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.
Evolutionary Systems Therapy for Schizotypy	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.

Primary Outcome Measures

Name	Time	Method
Change in general symptomatology	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 Outcome Measures

Name	Time	Method
Change in metacognition	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 others	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 2	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 critical beliefs about self	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 schizotypal traits 1	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 remission from primary diagnosis	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

Trial Locations

Locations (1)

Centro di Psicologia e Psicoterapia Tages Onlus - Firenze; 🇮🇹 Firenze, FI, Italy