Evolutionary Systems Therapy for Schizotypy

NCT05710926 | Unknown DMC

• 1 other identifier: ESTS-23
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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. 1.Is ESTS more effective than CBT in treating SPD?
2. 2.Is ESTS more feasible than CBT in treating SPD?

Conditions

Schizotypal Personality Disorder

Keywords

compassion; metacognition; personality disorder; schizotypy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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 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 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 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 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)

Study Arms (2)

Cognitive Behavioral Therapy

ACTIVE COMPARATOR

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

Evolutionary Systems Therapy for Schizotypy

EXPERIMENTAL

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

Interventions

Evolutionary Systems Therapy for Schizotypy BEHAVIORAL

A novel therapy for schizotypal traits integrating evolutionary psychopathology, compassion focused therapy, and metacognitively oriented psychotherapy.

Evolutionary Systems Therapy for Schizotypy

Cognitive Behavioral Therapy BEHAVIORAL

An adaptation of Cognitive Behavioral Therapy for those diagnosed with personaloty disorders.

Cognitive Behavioral Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tages Onlus: lead

Study Sites (1)

Centro di Psicologia e Psicoterapia Tages Onlus - Firenze

Florence, FI, 50137, Italy

RECRUITING

MeSH Terms

Conditions

Schizotypal Personality Disorder; Personality Disorders

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Simone Cheli, PhD

  Tages Onlus

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Simone Cheli, PhD

CONTACT

+393285642442; simone.cheli@tagesonlus.org

Marta Floridi, PsyD

CONTACT

+39055679037; marta.floridi@tagesonlus.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: An experienced first clinician will make the initial assessment without knowing the assignment to the two groups. Similarly, a second expert clinician will evaluate the participants at the end of th.e intervention without knowing the assignment to the two groups. The data will then be anonymized and a statistician will analyze them without knowing which group corresponds to which treatment
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants are randomly assignedon a 1:1 ratio to one of two groups in parallel for the duration of the study. Each participant will access a talk therapy lasting 6 months (24 weekly sessions).

Study Record Dates

• First Submitted: January 17, 2023
• First Posted: February 2, 2023
• Study Start: October 5, 2022
• Primary Completion: November 1, 2024
• Study Completion: January 1, 2025
• Last Updated: July 6, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Study protocol, SAP, and ICF will be shared before the end of February 2023.

Locations

IT (1)