Evolutionary Systems Therapy for Personality Pathology

NCT06415812 | Recruiting DMC

• 1 other identifier: 0124
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

Evolutionary Systems Therapy is a new form of therapy that has been previously tested in a randomized controlled trial and in a few cases of patients diagnosed with Cluster A personality disorders. The objective of the present study is to investigate the feasibility and preliminary efficacy of Evolutionary Systems Therapy in all forms of personality disorders. The study includes three project actions: (i) a case series on adolescents with personality disorders; (ii) a case series on young adults with personality disorders; (iii) an ecological momentary assessment study to confirm the conceptualization model on all the patients.

Conditions

Personality Disorders

Keywords

compassion; metacognition; personality disorder; personality pathology; evolutionary psychopathology

Outcome Measures

Primary Outcomes (3)

• Rate of individual change in personality pathology over time

  At least 75% rate of change in personality pathology over time as defined by a downward trend in mean of total score of Personality Inventory for DSM-5 Brief Form)

  9 measurements: one month before the start of therapy, at the start of therapy, at the end of each of the 6 months of therapy, one month after the end of therapy.

• Group change in personality pathology over time

  Group change in personality pathology over time as defined by statistically significant change of sample mean of total score of Personality Inventory for DSM-5 Brief Form)

  9 measurements: one month before the start of therapy, at the start of therapy, at the end of each of the 6 months of therapy, one month after the end of therapy.

• Feasibility of the intervention

  At least 70% rate of completion, adherence, therapeutic alliance and adverse events

  6 measurements: at the end of each of the six months of therapy

Secondary Outcomes (3)

• Differential effect of the intervention between interpersonal patterns

  9 measurements: one month before the start of therapy, at the start of therapy, at the end of each of the 6 months of therapy, one month after the end of therapy.

• Specific effect of the intervention between interpersonal patterns

  40 measurements: 20 measurements in the month before surgery (2 measurements per day for the 10 days before the start of therapy) and 20 measurements in the month after surgery (2 measurements per day for the 10 days after the end of therapy)

• Remission from diagnosis

  2 measurements: one at baseline assessment (once the intervention starts); one at final assessment (6 months after, that is after weekly scheduled 24 sessions)

Study Arms (1)

Psychotherapy

EXPERIMENTAL

All the participants receive as active treatment a form of psychotherapy for personality disorders (Evolutionary Systems Therapy). The treatment last 6 months (24 weekly sessions, each lasting 50-60 minutes).

Behavioral: Evolutionary Systems Therapy

Interventions

Evolutionary Systems Therapy BEHAVIORAL

Evolutionary Systems Therapy is an individual form of psychotherapy (talk therapy) that has been previously tested trough a randomized controlled trial and a few cases series, confirming its feasibility and safety.

Psychotherapy

Eligibility Criteria

• Age: 16 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Being diagnosed with personality pathology in accordance with Structured Clinical Interview for DSM-5 - Alternative Model of Personality Disorders Module I
• Being capable of read and sign the inform consent form

You may not qualify if:

• Being diagnosed with schizophrenia spectrum disorders and other psychosis
• Being diagnosed with bipolar disorders
• Being diagnosed with autism spectrum disorder
• Being diagnosed with intellectual disability
• Being under any psychopharmacological or psychosocial treatment

Sponsors & Collaborators

• Tages Onlus: lead

Study Sites (1)

Centro di Psicologia e Psicoterapia Tages Onlus - Firenze

Florence, FI, 50137, Italy

RECRUITING

Related Publications (5)

• Cheli, S., Chiarello, F., & Cavalletti, V. (2023). A psychotherapy oriented by compassion and metacognition for schizoid personality disorder: A two cases series. Journal of Contemporary Psychotherapy: On the Cutting Edge of Modern Developments in Psychotherapy, 53(1), 61-70. https://doi.org/10.1007/s10879-022-09566-3

  BACKGROUND

• Cheli, S., Cavalletti, V. An Evolutionarily Oriented Therapy for Autistic Adolescents with Extraordinary Skills: A Two-Case Series. J Contemp Psychother 53, 297-304 (2023). https://doi.org/10.1007/s10879-023-09586-7

  BACKGROUND

• Cheli, S., & Brüne, M. (In press). When do personality traits become pathological? An epistemological and evolutionary view. To appear in Konrad Banicki and Peter Zachar (Eds.), Novel Conceptual Approaches to Personality Disorders for Psychologists and Philosophers. Cambridge University Press.

  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 RESULT

• Cheli S, Goldzweig G, Chiarello F, Cavalletti V. Evolutionary systems therapy for paranoid personality disorder: A seven cases series. Bull Menninger Clin. 2024 Winter;88(1):61-80. doi: 10.1521/bumc.2024.88.1.61.

  PMID: 38527104 RESULT

MeSH Terms

Conditions

Personality Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Simone Cheli, PhD

  Tages Onlus

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alessia Saini

CONTACT

+39 055679037; alessia.saini@tagesonlus.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: All data will be collected in a blinded manner by an assessor other than the therapists. Subsequently, the data will be anonymized and analyzed by a researcher from an institution different from the one in which the study takes place.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Two individual parallel groups will be recruited: adolescent patients and young adult patients. Both groups will receive a 6-month Evolutionary Systems Therapy treatment. Both groups will access a longitudinal evaluation of the effectiveness of the treatment. All the participants will access a more extensive ecological momentary assessment to evaluate the progress of specific psychopathological mechanisms that are the targets of the treatment. Consistent with the conceptualization model of Evolutionary Systems Therapy and with the scientific literature on dimensional and hierarchical models of psychopathology, this conceptualization will be shared with the patient based on three macro-functionings: externalizing patterns, internalizing patterns, schizotypal patterns.

Study Record Dates

• First Submitted: May 10, 2024
• First Posted: May 16, 2024
• Study Start: October 2, 2023
• Primary Completion: August 1, 2024
• Study Completion: September 1, 2024
• Last Updated: May 16, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: May 2024
• Access Criteria: Open Access

Locations

IT (1)