Evolutionary Systems Therapy for Personality Pathology

Personality Disorders Clinical Trial

— ESTP  

Official title:

Evolutionary Systems Therapy for Early Onset of Personality Pathology: A Pilot Study on the Effectiveness and Feasibility With Adolescents and Young Adults

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06415812
• Other study ID #: 0124
• Status: Recruiting
• Phase: N/A
• Start date: October 2, 2023
• Est. completion date: September 2024

Study information

• Verified date: May 2024
• Source: Tages Onlus
• Contact: Alessia Saini
• Phone: +39 055679037
• Email: alessia.saini[@]tagesonlus.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

To explore the feasibility and preliminary efficacy of Evolutionary Systems Therapy, the present study includes three actions. In the first action investigators enroll 6 adolescents (16-19 years) with personality disorders, in the second 15 young adults (20-25 years) with personality disorders. All participants receive 6 months of psychotherapy. The two subsamples of patients (adolescents and young adults) are assessed based on the conceptualization model of Evolutionary Systems Therapy which envisages three macro-organizations of personality (consistently with dimensional and hierarchical models such as Hierarchical Taxonomy of Psychopathology): internalizing, externalizing, schizotypal. Investigators plan to recruit patients until the size of the sub-samples is reached (15 young adults divided into 3 groups of 5 patients, each for each of the three interpersonal patterns; 6 adolescents divided into 3 groups of 2 patients, each for each of the three patterns interpersonal). In the third action, an ecological momentary assessment study will investigate the consistency over time between the conceptualization model and the experiences of the young adult patients enrolled: investigators will explore whether the hypothesized conceptualization will be confirmed by collected data on the patients' interpersonal styles.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 21
• Est. completion date: September 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 25 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Personality Disorders

Intervention

Behavioral:
• Evolutionary Systems Therapy
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.

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 (5)

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 c — View Citation

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. — View Citation

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.

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

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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	Differential effect of the intervention between interpersonal patterns	Comparison between efficacy of intervention between three interpersonal patterns (internalizing, antagonistic, schizotypal) as being the target of the intervention. The comparison is aimed to show no statistically significant difference between the three patterns in terms of pre-post change in personality pathology as measured by 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.
Secondary	Specific effect of the intervention between interpersonal patterns	Comparison between efficacy of intervention between three interpersonal patterns (internalizing, antagonistic, schizotypal) as being the target of the intervention. The comparison is aimed to show no statistically significant difference between the three patterns in terms of pre-post change in personality pathology as measured by Personality Inventory for DSM-5 Brief Form.	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)
Secondary	Remission from diagnosis	At least 70% rate of remission from diagnosis of personality pathology	2 measurements: one at baseline assessment (once the intervention starts); one at final assessment (6 months after, that is after weekly scheduled 24 sessions)