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Schizotypal Personality DisorderCMBTNCT04764708

Compassion and Metacognition in Schizotypal Personality

A study testing Compassion and Metacognition Based Therapy and Cognitive Behavioral Therapy in people with Schizotypal Personality Disorder, run by Tages Onlus at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Schizotypal Personality Disorder
What is being tested?
Compassion and Metacognition Based Therapy and Cognitive Behavioral Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
1 siteItaly
Study dates
15 Dec 2020to 20 Dec 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • Centro di Psicologia e Psicoterapia Tages Onlus - Firenze

    Florence, FI, 50137

Other trials in Italy

About this study

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

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.

Read the 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.

Being tested
Compassion and Metacognition Based Therapy, Cognitive Behavioral Therapy
Keywords
schizotypy, psychotherapy, compassion-focused therapy, metacognitively oriented psychotherapy, metacognition, compassion
Medical subject headings
Schizotypal Personality Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Compassion and Metacognition Based TherapyBehavioural

    The intervention is a Third Wave Cognitive Therapy targeting metacognitive dysfuctions (through Metacognitively Oriented Psychotherapy) and self-criticism (through Compassion Focused Therapy).

  • Cognitive Behavioral TherapyBehavioural

    Also called Standard Psychopharmacological Treatment

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

Study groups in NCT04764708
Study groupRoleWhat they receive
Control GroupActive comparatorCognitive behavioral therapy plus standard psychopharmacological treatment.
Receives: Behavioral: Cognitive Behavioral Therapy
Experimental GroupExperimentalA Third Wave Cognitive Therapy that integrates Compassion Focused Therapy and Metacognitively Oriented Psychotherapy.
Receives: Behavioral: Compassion and Metacognition Based Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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)

  1. 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).

    Measured: Pre-post evaluation between pre-assessment (1-month before the intervention) and 1-month follow-up assessment.

  2. 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).

    Measured: Pre-post evaluation between pre-assessment (1-month before the intervention) and 1-month follow-up assessment.

  3. Metacognition

    Increase of Metacognition Assessment Scale - Abreviated (MAS-A) total score (with a range of 0 to 28; higher scores indicating higher metacognitive functioning).

    Measured: Pre-post evaluation between pre-assessment (1-month before the intervention) and 1-month follow-up assessment.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Feb 2021
  2. Study start15 Dec 2020
  3. Primary completion30 Sep 2021
  4. Study completion20 Dec 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized Controlled Trial with Repeated Measures
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04764708
Sponsor's protocol ID
03-07072020
Acronym
CMBT
Status last verified
Jun 2022
First submitted
12 Feb 2021
Last updated
21 Jun 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Individual partecipants data underline the results in all the future publications related to the trial will be available after deidentification.

Publications

  • 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.

    PubMed 31169366

  • 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.

    PubMed 32463252

  • 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.

    PubMed 30891894

  • 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.

    PubMed 30537720

  • 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.

    PubMed 25557317

  • 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.

    PubMed 32308511

  • 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.

    PubMed 29568726

  • 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.

    PubMed 17192140

  • 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.

    PubMed 32519017

  • 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.

    PubMed 30774614

  • 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.

    PubMed 29029675

  • 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.

    PubMed 25215860

  • 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.

    PubMed 32639097

  • 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.

    PubMed 24215148

  • 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.

    PubMed 25810057

Questions about this trial

What is this clinical trial studying?

A study testing Compassion and Metacognition Based Therapy and Cognitive Behavioral Therapy in people with Schizotypal Personality Disorder, run by Tages Onlus at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from Baseline Personality Pathology at 8 months (time frame: 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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04764708, which also lists 26 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2022.

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