Compassion and Metacognition in Schizotypal Personality

Study Overview
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Brief Summary
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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
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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.

Official Title
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Compassion and Metacognition Based Therapy for Schizotypal Personality Disorder: A Pilot Non-inferiority Randomized Controlled Trial on Repeated Measures.

Conditions
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Schizotypal Personality Disorder

Intervention / Treatment
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* Behavioral: Compassion and Metacognition Based Therapy
* Behavioral: Cognitive Behavioral Therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized Controlled Trial with Repeated Measures
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control Group<br>Cognitive behavioral therapy plus standard psychopharmacological treatment. | Behavioral: Cognitive Behavioral Therapy<br>* Standard Cognitive Behavioral Therapy for Personality Disorders plus Standard Psychopharmacological Treatment.<br>* Other names: Standard Psychopharmacological Treatment;|
| Experimental: Experimental Group<br>A Third Wave Cognitive Therapy that integrates Compassion Focused Therapy and Metacognitively Oriented Psychotherapy. | Behavioral: Compassion and Metacognition Based Therapy<br>* The intervention is a Third Wave Cognitive Therapy targeting metacognitive dysfuctions (through Metacognitively Oriented Psychotherapy) and self-criticism (through Compassion Focused Therapy).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline Personality Pathology at 8 months | Decrese of Personality Inventory for DSM-5 - Brief Form (PID-5-BF) total score (with a range of 0 to 75; higher scores indicating a more severe psychopathology) from baseline to final assessment after 8 months. | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Schizotypal Personality Disorder Diagnosis (SPD) | Recovery from SPD diagnosis at Module III of Structural Clinical Interview for DSM-5 Alternative Model of Personality Disorders (SCID-5-AMPD). | Pre-post evaluation between pre-assessment (1-month before the intervention) and 1-month follow-up assessment. | 
| General Psychopathology | Decrease of Global Severity Index (with a range of 0 to 4; higher scores indicating a more severe psychopathology) of the Symptom Checklist-90-R (SCL-90-R). | Pre-post evaluation between pre-assessment (1-month before the intervention) and 1-month follow-up assessment. | 
| Metacognition | Increase of Metacognition Assessment Scale - Abreviated (MAS-A) total score (with a range of 0 to 28; higher scores indicating higher metacognitive functioning). | Pre-post evaluation between pre-assessment (1-month before the intervention) and 1-month follow-up assessment. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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schizotypy, psychotherapy, compassion-focused therapy, metacognitively oriented psychotherapy, metacognition, compassion