Back to resultsCompassion and Metacognition in Schizotypal Personality (CMBT)
Primary Purpose
Schizotypal Personality Disorder
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Compassion and Metacognition Based Therapy
Cognitive Behavioral Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Schizotypal Personality Disorder focused on measuring schizotypy, psychotherapy, compassion-focused therapy, metacognitively oriented psychotherapy, metacognition, compassion
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
Sites / Locations
- Centro di Psicologia e Psicoterapia Tages Onlus - Firenze
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Control Group
Experimental Group
Arm Description
Cognitive behavioral therapy plus standard psychopharmacological treatment.
A Third Wave Cognitive Therapy that integrates Compassion Focused Therapy and Metacognitively Oriented Psychotherapy.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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).
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).
Metacognition
Increase of Metacognition Assessment Scale - Abreviated (MAS-A) total score (with a range of 0 to 28; higher scores indicating higher metacognitive functioning).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04764708
Brief Title
Compassion and Metacognition in Schizotypal Personality
Acronym
CMBT
Official Title
Compassion and Metacognition Based Therapy for Schizotypal Personality Disorder: A Pilot Non-inferiority Randomized Controlled Trial on Repeated Measures.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
December 15, 2020 (Actual)
Primary Completion Date
September 30, 2021 (Actual)
Study Completion Date
December 20, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tages Onlus
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizotypal Personality Disorder
Keywords
schizotypy, psychotherapy, compassion-focused therapy, metacognitively oriented psychotherapy, metacognition, compassion
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized Controlled Trial with Repeated Measures
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
Cognitive behavioral therapy plus standard psychopharmacological treatment.
Arm Title
Experimental Group
Arm Type
Experimental
Arm Description
A Third Wave Cognitive Therapy that integrates Compassion Focused Therapy and Metacognitively Oriented Psychotherapy.
Intervention Type
Behavioral
Intervention Name(s)
Compassion and Metacognition Based Therapy
Intervention Description
The intervention is a Third Wave Cognitive Therapy targeting metacognitive dysfuctions (through Metacognitively Oriented Psychotherapy) and self-criticism (through Compassion Focused Therapy).
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Therapy
Other Intervention Name(s)
Standard Psychopharmacological Treatment
Intervention Description
Standard Cognitive Behavioral Therapy for Personality Disorders plus Standard Psychopharmacological Treatment.
Primary Outcome Measure Information:
Title
Change from Baseline Personality Pathology at 8 months
Description
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.
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.
Secondary Outcome Measure Information:
Title
Schizotypal Personality Disorder Diagnosis (SPD)
Description
Recovery from SPD diagnosis at Module III of Structural Clinical Interview for DSM-5 Alternative Model of Personality Disorders (SCID-5-AMPD).
Time Frame
Pre-post evaluation between pre-assessment (1-month before the intervention) and 1-month follow-up assessment.
Title
General Psychopathology
Description
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).
Time Frame
Pre-post evaluation between pre-assessment (1-month before the intervention) and 1-month follow-up assessment.
Title
Metacognition
Description
Increase of Metacognition Assessment Scale - Abreviated (MAS-A) total score (with a range of 0 to 28; higher scores indicating higher metacognitive functioning).
Time Frame
Pre-post evaluation between pre-assessment (1-month before the intervention) and 1-month follow-up assessment.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Simone Cheli
Organizational Affiliation
Tages Onlus
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gil Goldzweig
Organizational Affiliation
The Academic College of Tel-Aviv Yaffo
Official's Role
Study Chair
Facility Information:
Facility Name
Centro di Psicologia e Psicoterapia Tages Onlus - Firenze
City
Firenze
State/Province
FI
ZIP/Postal Code
50137
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
Citations:
PubMed Identifier
31169366
Citation
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Citation
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Compassion and Metacognition in Schizotypal Personality
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