CMBT
Compassion and Metacognition Based Therapy for Schizotypal Personality Disorder: A Pilot Non-inferiority Randomized Controlled Trial on Repeated Measures.
Sponsor study identifier
interventional
16
1 country
1
Study Start
December 15, 2020
Actual (reported)Primary Completion
September 30, 2021
Actual (reported)Study Completion
December 20, 2021
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 20, 2021
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 15, 2020
Actual (reported)February 12, 2021
Actual (reported)February 21, 2021
Actual (reported)September 30, 2021
Actual (reported)December 20, 2021
Actual (reported)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.
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.
Cognitive behavioral therapy plus standard psychopharmacological treatment.
A Third Wave Cognitive Therapy that integrates Compassion Focused Therapy and Metacognitively Oriented Psychotherapy.
The intervention is a Third Wave Cognitive Therapy targeting metacognitive dysfuctions (through Metacognitively Oriented Psychotherapy) and self-criticism (through Compassion Focused Therapy).
Standard Cognitive Behavioral Therapy for Personality Disorders plus Standard Psychopharmacological Treatment.
Centro di Psicologia e Psicoterapia Tages Onlus - Firenze
Florence, FI, 50137, Italy
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.
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.
Simone Cheli
Tages Onlus
Gil Goldzweig
The Academic College of Tel-Aviv Yaffo
16 participants (actual enrollment reported by the registry).
First Submitted
February 12, 2021
First Posted
February 21, 2021
Study Start
December 15, 2020
Pain Resilience and Holistic Health Care of Migraine
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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(Suppl 2):S427-35. doi: 10.1093/schbul/sbu195.
Debbane M, Eliez S, Badoud D, Conus P, Fluckiger R, Schultze-Lutter F. Developing psychosis and its risk states through the lens of schizotypy. Schizophr Bull. 2015 Mar;41 Suppl 2(Suppl 2):S396-407. doi: 10.1093/schbul/sbu176. Epub 2014 Dec 29.
Mason OJ. The assessment of schizotypy and its clinical relevance. Schizophr Bull. 2015 Mar;41 Suppl 2(Suppl 2):S374-85. doi: 10.1093/schbul/sbu194.
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.
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.
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.
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.
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.
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.
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.
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, 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.
Primary Completion
September 30, 2021
Actual (reported)Study Completion
December 20, 2021
Actual (reported)Last Updated
June 21, 2022
Record last verified: 2022-06
Individual partecipants data underline the results in all the future publications related to the trial will be available after deidentification.
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Source: ClinicalTrials.gov.
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