Compassion and Metacognition in Schizotypal Personality (CMBT)

June 16, 2022 updated by: Simone Cheli, Tages Onlus

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

16

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • FI
      • Firenze, FI, Italy, 50137
        • Centro di Psicologia e Psicoterapia Tages Onlus - Firenze

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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)
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).
Pre-post evaluation between pre-assessment (1-month before the intervention) and 1-month follow-up assessment.
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).
Pre-post evaluation between pre-assessment (1-month before the intervention) and 1-month follow-up assessment.
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).
Pre-post evaluation between pre-assessment (1-month before the intervention) and 1-month follow-up assessment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tages Onlus

Investigators

  • Principal Investigator: Simone Cheli, Tages Onlus
  • Study Chair: Gil Goldzweig, The Academic College of Tel-Aviv Yaffo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 15, 2020

Primary Completion (Actual)

September 30, 2021

Study Completion (Actual)

December 20, 2021

Study Registration Dates

First Submitted

February 12, 2021

First Submitted That Met QC Criteria

February 17, 2021

First Posted (Actual)

February 21, 2021

Study Record Updates

Last Update Posted (Actual)

June 21, 2022

Last Update Submitted That Met QC Criteria

June 16, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 03-07072020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Individual partecipants data underline the results in all the future publications related to the trial will be available after deidentification.

IPD Sharing Time Frame

IPD will be released at the end of the study and will be accessible permanently.

IPD Sharing Access Criteria

IPD will be accessible on a dedicated web adress inside Tages Onlus website. The page will be released after the end of the study.

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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