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Evolutionary Systems Therapy for Schizotypy

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05710926
Acronym
ESTS-RCT
Enrollment
28
Registered
2023-02-02
Start date
2022-10-05
Completion date
2025-01-01
Last updated
2023-07-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizotypal Personality Disorder

Keywords

compassion, metacognition, personality disorder, schizotypy

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:

Interventions

BEHAVIORALEvolutionary Systems Therapy for Schizotypy

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

BEHAVIORALCognitive Behavioral Therapy

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

Sponsors

Tages Onlus
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Masking description

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

Intervention model description

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).

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in general symptomatology2 measurements: one at baseline assessment; one at final assessmentChange in the total score of Symptom Checklist-90-R (SCL-90-R) between two measurements

Secondary

MeasureTime frameDescription
Change in critical beliefs about self2 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 critical beliefs about others2 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 metacognition2 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 schizotypal traits 22 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 remission from primary diagnosis2 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
Change in schizotypal traits 12 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

Countries

Italy

Contacts

Primary ContactSimone Cheli, PhD
simone.cheli@tagesonlus.org+393285642442
Backup ContactMarta Floridi, PsyD
marta.floridi@tagesonlus.org+39055679037

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026