Compassion and Metacognition in Schizotypal Personality

Not Applicable

Completed

• Conditions: Schizotypal Personality Disorder
• Interventions: Behavioral: Compassion and Metacognition Based Therapy; Behavioral: Cognitive Behavioral Therapy

• Registration Number: NCT04764708
• Lead Sponsor: Tages Onlus

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.

Study Timeline

• Study Start: 2020-12-15
• Study First Submitted: 2021-02-12
• Study First Submitted QC: 2021-02-17
• Study First Posted: 2021-02-21
• Primary Completion: 2021-09-30
• Study Completion: 2021-12-20
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-16
• Last Update Posted: 2022-06-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental Group	Compassion and Metacognition Based Therapy	A Third Wave Cognitive Therapy that integrates Compassion Focused Therapy and Metacognitively Oriented Psychotherapy.
Control Group	Cognitive Behavioral Therapy	Cognitive behavioral therapy plus standard psychopharmacological treatment.

Primary Outcome Measures

Name	Time	Method
Change from Baseline Personality Pathology at 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.	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.

Secondary Outcome Measures

Name	Time	Method
Schizotypal Personality Disorder Diagnosis (SPD)	Pre-post evaluation between pre-assessment (1-month before the intervention) and 1-month follow-up assessment.	Recovery from SPD diagnosis at Module III of Structural Clinical Interview for DSM-5 Alternative Model of Personality Disorders (SCID-5-AMPD).
General Psychopathology	Pre-post evaluation between pre-assessment (1-month before the intervention) and 1-month follow-up assessment.	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).
Metacognition	Pre-post evaluation between pre-assessment (1-month before the intervention) and 1-month follow-up assessment.	Increase of Metacognition Assessment Scale - Abreviated (MAS-A) total score (with a range of 0 to 28; higher scores indicating higher metacognitive functioning).

Trial Locations

Locations (1)

Centro di Psicologia e Psicoterapia Tages Onlus - Firenze; 🇮🇹 Firenze, FI, Italy