Compassion and Metacognition in Schizotypal Personality

NCT04764708 | Completed DMC

• 1 other identifier: 03-07072020
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizotypal Personality Disorder

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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.

Study Arms (2)

Control Group

ACTIVE COMPARATOR

Cognitive behavioral therapy plus standard psychopharmacological treatment.

Behavioral: Cognitive Behavioral Therapy

Experimental Group

EXPERIMENTAL

A Third Wave Cognitive Therapy that integrates Compassion Focused Therapy and Metacognitively Oriented Psychotherapy.

Behavioral: Compassion and Metacognition Based Therapy

Interventions

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).

Experimental Group

Cognitive Behavioral Therapy BEHAVIORAL

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

Also known as: Standard Psychopharmacological Treatment

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Being diagnosed with Schizotypal Personality Disorder at SCID-5-AMPD

You may not qualify if:

• 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

Sponsors & Collaborators

• Tages Onlus: lead

Study Sites (1)

Centro di Psicologia e Psicoterapia Tages Onlus - Firenze

Florence, FI, 50137, Italy

Location

Related Publications (26)

• 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.

  PMID: 31169366 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.

  PMID: 32463252 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.

  PMID: 30891894 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.

  PMID: 30537720 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.

  PMID: 25557317 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.

  PMID: 32308511 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.

  PMID: 29568726 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.

  PMID: 17192140 BACKGROUND

• 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.

  PMID: 32519017 BACKGROUND

• 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.

  PMID: 30774614 BACKGROUND

• 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.

  PMID: 29029675 BACKGROUND

• 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.

  PMID: 25215860 BACKGROUND

• 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.

  PMID: 32639097 BACKGROUND

• 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.

  PMID: 24215148 BACKGROUND

• 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.

  PMID: 25810057 BACKGROUND

• 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.

  PMID: 25548386 BACKGROUND

• 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.

  PMID: 25810054 BACKGROUND

• 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.

  PMID: 32461089 BACKGROUND

• 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.

  PMID: 29474661 BACKGROUND

• 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.

  PMID: 30282970 BACKGROUND

• 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.

  PMID: 24828284 BACKGROUND

• 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.

  PMID: 25415496 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.

  PMID: 30261937 BACKGROUND

• 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.

  PMID: 28447827 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

  BACKGROUND

• 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.

  PMID: 36803673 DERIVED

MeSH Terms

Conditions

Schizotypal Personality Disorder

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Personality Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Simone Cheli

  Tages Onlus

  PRINCIPAL INVESTIGATOR

• Gil Goldzweig

  The Academic College of Tel-Aviv Yaffo

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized Controlled Trial with Repeated Measures

Study Record Dates

• First Submitted: February 12, 2021
• First Posted: February 21, 2021
• Study Start: December 15, 2020
• Primary Completion: September 30, 2021
• Study Completion: December 20, 2021
• Last Updated: June 21, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: IPD will be released at the end of the study and will be accessible permanently.
• Access Criteria: IPD will be accessible on a dedicated web adress inside Tages Onlus website. The page will be released after the end of the study.

Locations

IT (1)