Evolutionary Systems Therapy for Schizotypy (ESTS-RCT)

Tages Onlus

Status: Enrolling

Conditions: Schizotypal Personality Disorder

Treatments: Behavioral: Cognitive Behavioral Therapy; Behavioral: Evolutionary Systems Therapy for Schizotypy

Study type: Interventional

Funder types: Other

Identifiers

NCT05710926

ESTS-23

Details and patient eligibility

About

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.

Full 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:

Enrollment: 28 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

28 participants in 2 patient groups

Cognitive Behavioral Therapy

Active Comparator group

Description:

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.

Treatment:

Behavioral: Cognitive Behavioral Therapy

Evolutionary Systems Therapy for Schizotypy

Experimental group

Description:

Evolutionary Systems Therapy for Schizotypy as manualized by Cheli and colleagues in their trial (2023) will be delivered to partecipants in the experimental group.

Treatment:

Behavioral: Evolutionary Systems Therapy for Schizotypy