Clinical trial NCT05710926: Evolutionary Systems Therapy for Schizotypy
Official title: A Confirmatory Randomized Controlled Trial Comparing Evolutionary Systems Therapy for Schizotypal Personality Disorder With Cognitive Behavioral Therapy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Schizotypal Personality Disorder
Keywords: compassion
metacognition
personality disorder
schizotypy
Lead sponsor: Tages Onlus
Sponsor class: OTHER
First posted: 2023-02-02
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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).
Primary purpose: TREATMENT

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:

Eligibility criteria: 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

Primary outcomes:
measure: Change in general symptomatology
timeFrame: 2 measurements: one at baseline assessment; one at final assessment
Secondary outcomes:
measure: Change in metacognition
timeFrame: 2 measurements: one at baseline assessment (once the intervention starts); one at final assessment (6 months after, that is after weekly scheduled 24 sessions)
measure: Change in critical beliefs about self
timeFrame: 2 measurements: one at baseline assessment (once the intervention starts); one at final assessment (6 months after, that is after weekly scheduled 24 sessions)
measure: Change in critical beliefs about others
timeFrame: 2 measurements: one at baseline assessment (once the intervention starts); one at final assessment (6 months after, that is after weekly scheduled 24 sessions)
measure: Change in schizotypal traits 1
timeFrame: 2 measurements: one at baseline assessment (once the intervention starts); one at final assessment (6 months after, that is after weekly scheduled 24 sessions)
measure: Change in schizotypal traits 2
timeFrame: 2 measurements: one at baseline assessment (once the intervention starts); one at final assessment (6 months after, that is after weekly scheduled 24 sessions)
measure: Change in remission from primary diagnosis
timeFrame: 2 measurements: one at baseline assessment (once the intervention starts); one at final assessment (6 months after, that is after weekly scheduled 24 sessions)
Other outcomes:
Locations:
city: Firenze
country: Italy
facility: Centro di Psicologia e Psicoterapia Tages Onlus - Firenze
state: FI
Study officials:
affiliation: Tages Onlus
name: Simone Cheli, PhD
role: PRINCIPAL_INVESTIGATOR
References: