Skip to content

Compassion and Metacognition in Schizotypal Personality

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04764708
Acronym
CMBT
Enrollment
16
Registered
2021-02-21
Start date
2020-12-15
Completion date
2021-12-20
Last updated
2022-06-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizotypal Personality Disorder

Keywords

schizotypy, psychotherapy, compassion-focused therapy, metacognitively oriented psychotherapy, metacognition, compassion

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.

Interventions

BEHAVIORALCompassion 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).

BEHAVIORALCognitive Behavioral Therapy

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

Sponsors

Tages Onlus
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Intervention model description

Randomized Controlled Trial with Repeated Measures

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change from Baseline Personality Pathology at 8 months9 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

MeasureTime frameDescription
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 PsychopathologyPre-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).
MetacognitionPre-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).

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026