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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group | Active Comparator | Cognitive behavioral therapy plus standard psychopharmacological treatment. |
|
| Experimental Group | Experimental | A Third Wave Cognitive Therapy that integrates Compassion Focused Therapy and Metacognitively Oriented Psychotherapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Pre-post evaluation between pre-assessment (1-month before the intervention) and 1-month follow-up assessment. |
| General Psychopathology |
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Inclusion Criteria:
- Being diagnosed with Schizotypal Personality Disorder at SCID-5-AMPD
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Simone Cheli | Tages Onlus | Principal Investigator |
| Gil Goldzweig | The Academic College of Tel-Aviv Yaffo | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centro di Psicologia e Psicoterapia Tages Onlus - Firenze | Florence | FI | 50137 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31169366 | Background | Cheli S, Lysaker PH, Dimaggio G. Metacognitively oriented psychotherapy for schizotypal personality disorder: A two-case series. Personal Ment Health. 2019 Aug;13(3):155-167. doi: 10.1002/pmh.1447. Epub 2019 Jun 6. | |
| 32463252 | Background | Cheli S. Assessment and treatment planning for schizotypal personality disorder: A metacognitively oriented point of view. Psychiatr Rehabil J. 2020 Dec;43(4):335-343. doi: 10.1037/prj0000429. Epub 2020 May 28. |
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Individual partecipants data underline the results in all the future publications related to the trial will be available after deidentification.
IPD will be released at the end of the study and will be accessible permanently.
IPD will be accessible on a dedicated web adress inside Tages Onlus website. The page will be released after the end of the study.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Feb 17, 2021 | Feb 17, 2021 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D012569 | Schizotypal Personality Disorder |
| ID | Term |
|---|---|
| D010554 | Personality Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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Randomized Controlled Trial with Repeated Measures
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| Cognitive Behavioral Therapy | Behavioral | Standard Cognitive Behavioral Therapy for Personality Disorders plus Standard Psychopharmacological Treatment. |
|
|
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 | 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. |
| 30891894 | Background | Petrocchi N, Cheli S. The social brain and heart rate variability: Implications for psychotherapy. Psychol Psychother. 2019 Jun;92(2):208-223. doi: 10.1111/papt.12224. Epub 2019 Mar 20. |
| 30537720 | Background | Lysaker PH, Dimaggio G, Hamm JA, Leonhardt BL, Hochheiser J, Lysaker JT. Disturbances in Self-Experience in Schizophrenia: Metacognition and the Development of an Integrative Recovery-Oriented Individual Psychotherapy. Psychopathology. 2019;52(2):135-142. doi: 10.1159/000495297. Epub 2018 Dec 11. |
| 25557317 | Background | Dimaggio G, Lysaker PH. Metacognition and mentalizing in the psychotherapy of patients with psychosis and personality disorders. J Clin Psychol. 2015 Feb;71(2):117-24. doi: 10.1002/jclp.22147. Epub 2014 Dec 31. |
| 32308511 | Background | Lysaker PH, Gagen E, Klion R, Zalzala A, Vohs J, Faith LA, Leonhardt B, Hamm J, Hasson-Ohayon I. Metacognitive Reflection and Insight Therapy: A Recovery-Oriented Treatment Approach for Psychosis. Psychol Res Behav Manag. 2020 Apr 2;13:331-341. doi: 10.2147/PRBM.S198628. eCollection 2020. |
| 29568726 | Background | Lysaker PH, Hamm JA, Hasson-Ohayon I, Pattison ML, Leonhardt BL. Promoting recovery from severe mental illness: Implications from research on metacognition and metacognitive reflection and insight therapy. World J Psychiatry. 2018 Mar 22;8(1):1-11. doi: 10.5498/wjp.v8.i1.1. eCollection 2018 Mar 22. |
| 17192140 | Background | Dimaggio G, Semerari A, Carcione A, Procacci M, Nicolo G. Toward a model of self pathology underlying personality disorders: narratives, metacognition, interpersonal cycles and decision-making processes. J Pers Disord. 2006 Dec;20(6):597-617. doi: 10.1521/pedi.2006.20.6.597. |
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| 30261937 | Background | Volkert J, Gablonski TC, Rabung S. Prevalence of personality disorders in the general adult population in Western countries: systematic review and meta-analysis. Br J Psychiatry. 2018 Dec;213(6):709-715. doi: 10.1192/bjp.2018.202. Epub 2018 Sep 28. |
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| Background | Cheli S, Cavalletti V, Petrocchi N (2020) An online compassion-focused crisis intervention during COVID-19 lockdown: a cases series on patients at high risk for psychosis, Psychosis, 12:4, 359-362, DOI: 10.1080/17522439.2020.1786148 |
| 36803673 | Derived | Cheli S, Cavalletti V, Lysaker PH, Dimaggio G, Petrocchi N, Chiarello F, Enzo C, Velicogna F, Mancini F, Goldzweig G. A pilot randomized controlled trial comparing a novel compassion and metacognition approach for schizotypal personality disorder with a combination of cognitive therapy and psychopharmacological treatment. BMC Psychiatry. 2023 Feb 20;23(1):113. doi: 10.1186/s12888-023-04610-5. |