Compassion and Metacognition Based Therapy for Schizotypal Personality Disorder: A Pilot Non-inferiority Randomized Controlled Trial on Repeated Measures.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Schizotypal Personality Disorder
- Sponsor
- Tages Onlus
- Enrollment
- 16
- Locations
- 1
- Primary Endpoint
- Change from Baseline Personality Pathology at 8 months
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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.
Investigators
Simone Cheli
Principal Investigator
Tages Onlus
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
Outcomes
Primary Outcomes
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
- Schizotypal Personality Disorder Diagnosis (SPD)(Pre-post evaluation between pre-assessment (1-month before the intervention) and 1-month follow-up assessment.)
- General Psychopathology(Pre-post evaluation between pre-assessment (1-month before the intervention) and 1-month follow-up assessment.)
- Metacognition(Pre-post evaluation between pre-assessment (1-month before the intervention) and 1-month follow-up assessment.)