Clinical trial NCT04764708: Compassion and Metacognition in Schizotypal Personality
Official title: Compassion and Metacognition Based Therapy for Schizotypal Personality Disorder: A Pilot Non-inferiority Randomized Controlled Trial on Repeated Measures.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizotypal Personality Disorder
Keywords: schizotypy
psychotherapy
compassion-focused therapy
metacognitively oriented psychotherapy
metacognition
compassion
Lead sponsor: Tages Onlus
Sponsor class: OTHER
First posted: 2021-02-21
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled Trial with Repeated Measures
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the safety and efficacy of a newly developed psychotherapy for schizotypal personality disorder. This new form of psychotherapy integrates compassion focused therapy and metacognitively oriented psychotherapy.

Detailed description: After being informed about the study and potential risks, all patients giving written informed consent will undergo a psychological assessment so as to determine eligibility for study entry. Patients who meet the eligibility requirements will be randomized in a double-blind manner in a 1:1 ratio to new integrative psychotherapy or treatment as usual (cognitive behavioral therapy plus standard psychopharmacological treatment). One month after the conclusion of the two forms of treatment (both lasting 6 months), patients will have access to the final follow-up assessment.

Eligibility criteria: Inclusion Criteria:

- Being diagnosed with Schizotypal Personality Disorder at SCID-5-AMPD

Exclusion Criteria:

* Being under psychotherapy or psychopahrnacological treatment
* Being diagnosed with schizophrenia and other psychotic disorders
* Being diagnosed with bipolar disorder
* Being diagnosed with intelletual disability
* Being diagnosed with any neurological disases

Primary outcomes:
measure: Change from Baseline Personality Pathology at 8 months
timeFrame: 9 measurements over the course of 8 months: (i) at 1 month before intervention starts; (ii) once the treatment starts; (iii) 6 measurements at the end of each month of intervention; iv) at 1-month follow-up.
Secondary outcomes:
measure: Schizotypal Personality Disorder Diagnosis (SPD)
timeFrame: Pre-post evaluation between pre-assessment (1-month before the intervention) and 1-month follow-up assessment.
measure: General Psychopathology
timeFrame: Pre-post evaluation between pre-assessment (1-month before the intervention) and 1-month follow-up assessment.
measure: Metacognition
timeFrame: Pre-post evaluation between pre-assessment (1-month before the intervention) and 1-month follow-up assessment.
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
role: PRINCIPAL_INVESTIGATOR
affiliation: The Academic College of Tel-Aviv Yaffo
name: Gil Goldzweig
role: STUDY_CHAIR
References:
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