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Completed

NCT Number: NCT04764708

Compassion and Metacognition in Schizotypal Personality

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.

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Key information

Conditions

Schizotypal Personality Disorder Mental Disorders Personality Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centro di Psicologia e Psicoterapia Tages Onlus - Firenze

Florence, FI, 50137, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Compassion and Metacognition Based Therapy

Behavioral

The intervention is a Third Wave Cognitive Therapy targeting metacognitive dysfuctions (through Metacognitively Oriented Psychotherapy) and self-criticism (through Compassion Focused Therapy).

Cognitive behavioral therapy

Behavioral

Standard Cognitive Behavioral Therapy for Personality Disorders plus Standard Psychopharmacological Treatment.

Other names: Standard Psychopharmacological Treatment

Primary outcomes

  1. Change from Baseline Personality Pathology at 8 months

    Time frame: 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 outcomes

  1. Schizotypal Personality Disorder Diagnosis (SPD)

    Time frame: 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).

  2. General Psychopathology

    Time frame: 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).

  3. Metacognition

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Tages Onlus

Other

Registry information

Official study title

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

Acronym: CMBT

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Feb 21, 2021
Registry last updated
Jun 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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