Evolutionary Systems Therapy for Schizotypy

NCT ID: NCT05710926

Last Updated: 2023-07-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-05

Study Completion Date

2025-01-01

Brief Summary

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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

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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:

Conditions

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Schizotypal Personality Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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).
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors
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

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Cognitive Behavioral Therapy

Intervention Type BEHAVIORAL

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

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.

Group Type EXPERIMENTAL

Evolutionary Systems Therapy for Schizotypy

Intervention Type BEHAVIORAL

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

Interventions

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Evolutionary Systems Therapy for Schizotypy

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

Intervention Type BEHAVIORAL

Cognitive Behavioral Therapy

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tages Onlus

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Simone Cheli, PhD

Role: PRINCIPAL_INVESTIGATOR

Tages Onlus

Locations

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Centro di Psicologia e Psicoterapia Tages Onlus - Firenze

Florence, FI, Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Simone Cheli, PhD

Role: CONTACT

+393285642442

Marta Floridi, PsyD

Role: CONTACT

+39055679037

Facility Contacts

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Veronica Cavalletti

Role: primary

+39 055 679037

Marta Floridi

Role: backup

Other Identifiers

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ESTS-23

Identifier Type: -

Identifier Source: org_study_id

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