Compassion and Metacognition in Schizotypal Personality

Schizotypal Personality Disorder Clinical Trial

— CMBT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04764708
• Other study ID #: 03-07072020
• Status: Completed
• Phase: N/A
• Start date: December 15, 2020
• Est. completion date: December 20, 2021

Study information

• Verified date: June 2022
• Source: Tages Onlus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: December 20, 2021
• Est. primary completion date: September 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Personality Disorders
• Schizotypal Personality Disorder

Intervention

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

Locations

Country	Name	City	State
Italy	Centro di Psicologia e Psicoterapia Tages Onlus - Firenze	Firenze	FI

Sponsors (1)

Lead Sponsor	Collaborator
Tages Onlus

Country where clinical trial is conducted

Italy, 

References & Publications (25)

Balaratnasingam S, Janca A. Normal personality, personality disorder and psychosis: current views and future perspectives. Curr Opin Psychiatry. 2015 Jan;28(1):30-4. doi: 10.1097/YCO.0000000000000124. Review. — View Citation

Bora E. Theory of mind and schizotypy: A meta-analysis. Schizophr Res. 2020 Aug;222:97-103. doi: 10.1016/j.schres.2020.04.024. Epub 2020 May 25. Review. — View Citation

Braehler C, Gumley A, Harper J, Wallace S, Norrie J, Gilbert P. Exploring change processes in compassion focused therapy in psychosis: results of a feasibility randomized controlled trial. Br J Clin Psychol. 2013 Jun;52(2):199-214. doi: 10.1111/bjc.12009. Epub 2012 Oct 24. — View Citation

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

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. — View Citation

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. — View Citation

Cohen AS, Mohr C, Ettinger U, Chan RC, Park S. Schizotypy as an organizing framework for social and affective sciences. Schizophr Bull. 2015 Mar;41 Suppl 2:S427-35. doi: 10.1093/schbul/sbu195. Review. — View Citation

Debbané M, Eliez S, Badoud D, Conus P, Flückiger R, Schultze-Lutter F. Developing psychosis and its risk states through the lens of schizotypy. Schizophr Bull. 2015 Mar;41 Suppl 2:S396-407. doi: 10.1093/schbul/sbu176. Epub 2014 Dec 29. Review. — View Citation

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. — View Citation

Dimaggio G, Semerari A, Carcione A, Procacci M, Nicolò 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. Review. — View Citation

Grant P, Green MJ, Mason OJ. Models of Schizotypy: The Importance of Conceptual Clarity. Schizophr Bull. 2018 Oct 15;44(suppl_2):S556-S563. doi: 10.1093/schbul/sby012. Review. — View Citation

Heriot-Maitland C, McCarthy-Jones S, Longden E, Gilbert P. Compassion Focused Approaches to Working With Distressing Voices. Front Psychol. 2019 Feb 1;10:152. doi: 10.3389/fpsyg.2019.00152. eCollection 2019. — View Citation

Kirby JN, Tellegen CL, Steindl SR. A Meta-Analysis of Compassion-Based Interventions: Current State of Knowledge and Future Directions. Behav Ther. 2017 Nov;48(6):778-792. doi: 10.1016/j.beth.2017.06.003. Epub 2017 Jun 21. Review. — View Citation

Kirchner SK, Roeh A, Nolden J, Hasan A. Diagnosis and treatment of schizotypal personality disorder: evidence from a systematic review. NPJ Schizophr. 2018 Oct 3;4(1):20. doi: 10.1038/s41537-018-0062-8. Review. — View Citation

Kramer U, Beuchat H, Grandjean L, Pascual-Leone A. How Personality Disorders Change in Psychotherapy: a Concise Review of Process. Curr Psychiatry Rep. 2020 Jun 9;22(8):41. doi: 10.1007/s11920-020-01162-3. Review. — View Citation

Leaviss J, Uttley L. Psychotherapeutic benefits of compassion-focused therapy: an early systematic review. Psychol Med. 2015 Apr;45(5):927-45. doi: 10.1017/S0033291714002141. Epub 2014 Sep 12. Review. — View Citation

Lucre K, Clapton N. The Compassionate Kitbag: A creative and integrative approach to compassion-focused therapy. Psychol Psychother. 2021 Apr;94 Suppl 2:497-516. doi: 10.1111/papt.12291. Epub 2020 Jul 8. Review. — View Citation

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. — View Citation

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. Review. — View Citation

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. Review. — View Citation

Mason OJ. The assessment of schizotypy and its clinical relevance. Schizophr Bull. 2015 Mar;41 Suppl 2:S374-85. doi: 10.1093/schbul/sbu194. Review. — View Citation

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. Review. — View Citation

Rosell DR, Futterman SE, McMaster A, Siever LJ. Schizotypal personality disorder: a current review. Curr Psychiatry Rep. 2014 Jul;16(7):452. doi: 10.1007/s11920-014-0452-1. Review. — View Citation

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. — View Citation

Wilson S, Stroud CB, Durbin CE. Interpersonal dysfunction in personality disorders: A meta-analytic review. Psychol Bull. 2017 Jul;143(7):677-734. doi: 10.1037/bul0000101. Epub 2017 Apr 27. Review. — View Citation

* Note: There are 25 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Secondary	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.
Secondary	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).	Pre-post evaluation between pre-assessment (1-month before the intervention) and 1-month follow-up assessment.
Secondary	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.