Schizotypal Personality DisorderESTS-RCTNCT05710926
Evolutionary Systems Therapy for Schizotypy
A study testing Evolutionary Systems Therapy for Schizotypy and Cognitive Behavioral Therapy in people with Schizotypal Personality Disorder, run by Tages Onlus at 1 site in Italy.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Schizotypal Personality Disorder
- What is being tested?
- Evolutionary Systems Therapy for Schizotypy and Cognitive Behavioral Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteItaly
- Study dates
- 5 Oct 2022to 1 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Centro di Psicologia e Psicoterapia Tages Onlus - Firenze
Florence, FI, 50137
Veronica Cavalletti, +39 055 679037, veronica.cavalletti@tagesonlus.org
Marta Floridi, marta.floridi@tagesonlus.org
About this study
Official title: A Confirmatory Randomized Controlled Trial Comparing Evolutionary Systems Therapy for Schizotypal Personality Disorder With Cognitive Behavioral Therapy
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:
- Is ESTS more effective than CBT in treating SPD?
- 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.
Read the 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:
- Conditions
- Schizotypal Personality Disorder
- Being tested
- Evolutionary Systems Therapy for Schizotypy, Cognitive Behavioral Therapy
- Keywords
- compassion, metacognition, personality disorder, schizotypy
- Medical subject headings
- Schizotypal Personality Disorder, Personality Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evolutionary Systems Therapy for SchizotypyBehavioural
A novel therapy for schizotypal traits integrating evolutionary psychopathology, compassion focused therapy, and metacognitively oriented psychotherapy.
Cognitive Behavioral TherapyBehavioural
An adaptation of Cognitive Behavioral Therapy for those diagnosed with personaloty disorders.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Evolutionary Systems Therapy for Schizotypy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in general symptomatology
Change in the total score of Symptom Checklist-90-R (SCL-90-R) between two measurements
Measured: 2 measurements: one at baseline assessment; one at final assessment
Secondary outcomes (6)
Change in metacognition
Change in total score of Metacognition Assessment Scale - Abbreviated (MAS-A) between two measurements
Measured: 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
Change in the Hated-self scale of The Forms of Self-Criticizing/attacking and Self-reassuring Scale (FSCRS) between two measurements
Measured: 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
Change in Socially prescribed perfectionism scale of Multidimensional Perfectionism Scale (MPS) between two measurements
Measured: 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
Change in Psychoticism scale of Personality Inventory for DSM-5 (PID-5) between two measurements
Measured: 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
Change in Detachment scale of Personality Inventory for DSM-5 (PID-5) between two measurements
Measured: 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 remission from primary diagnosis
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
Measured: 2 measurements: one at baseline assessment (once the intervention starts); one at final assessment (6 months after, that is after weekly scheduled 24 sessions)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2023
- Study start5 Oct 2022
- Primary completion1 Nov 2024 (estimated)
- Study completion1 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Schizotypal Personality DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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).
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tages Onlus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Simone Cheli, PhD, Principal investigator, Tages Onlus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05710926
- Sponsor's protocol ID
- ESTS-23
- Acronym
- ESTS-RCT
- Status last verified
- Jul 2023
- First submitted
- 17 Jan 2023
- Last updated
- 6 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be anonymized and shared through Open Science Foundation at the end of the study.
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Confirmatory Randomized Controlled Trial Comparing Evolutionary Systems Therapy for Schizotypal Personality Disorder With Cognitive Behavioral Therapy
- ClinicalTrials.gov ID
- NCT05710926
- Acronym / sponsor ID
- ESTS-RCT / ESTS-23
- Conditions
- Schizotypal Personality Disorder
- Keywords
- compassion, metacognition, personality disorder, schizotypy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Tages OnlusUniversity, hospital or other
- Study start
- 5 Oct 2022 (actual)
- Primary completion
- 1 Nov 2024 (estimated)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 2 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Is ESTS more effective than CBT in treating SPD?
- 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:
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| Cognitive Behavioral Therapy | Active comparator | Behavioral: Cognitive Behavioral TherapyCognitive 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. |
| Evolutionary Systems Therapy for Schizotypy | Experimental | Behavioral: Evolutionary Systems Therapy for SchizotypyEvolutionary Systems Therapy for Schizotypy as manualized by Cheli and colleagues in their trial (2023) will be delivered to partecipants in the experimental group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Evolutionary Systems Therapy for SchizotypyA novel therapy for schizotypal traits integrating evolutionary psychopathology, compassion focused therapy, and metacognitively oriented psychotherapy. | Behavioural | Evolutionary Systems Therapy for Schizotypy |
| Cognitive Behavioral TherapyAn adaptation of Cognitive Behavioral Therapy for those diagnosed with personaloty disorders. | Behavioural | Cognitive Behavioral Therapy |
Primary outcome
Change in general symptomatology
Time frame: 2 measurements: one at baseline assessment; one at final assessment
Change in the total score of Symptom Checklist-90-R (SCL-90-R) between two measurements
6 secondary outcomes
Change in metacognition
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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 remission from primary diagnosis
Time frame: 2 measurements: one at baseline assessment (once the intervention starts); one at final assessment (6 months after, that is after weekly scheduled 24 sessions)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2023.
- Individual participant dataSharing planned: Yes. The data will be anonymized and shared through Open Science Foundation at the end of the study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Simone Cheli, PhD principal investigator
Tages Onlus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Evolutionary Systems Therapy for Schizotypy and Cognitive Behavioral Therapy in people with Schizotypal Personality Disorder, run by Tages Onlus at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Simone Cheli, PhD (+393285642442, simone.cheli@tagesonlus.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in general symptomatology (time frame: 2 measurements: one at baseline assessment; one at final assessment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2023.