NCT06913738

Brief Summary

The goal of this clinical trial is to evaluate whether a dimensional adaptation of Good Psychiatric Management (called GPM-extended) is more effective than classic Good Psychiatric Management (GPM) in treating adult patients with borderline personality disorder (BPD). Briefly, the GPM-extended model integrates elements from existing adaptations of GPM for narcissistic and obsessive-compulsive personality disorders. It aims to provide a more personalized and dimensional approach to treatment, tailored to each patient's specific personality dysfunction and interpersonal triggers. The main questions it aims to answer are:

  • Does GPM-extended improve overall BPD symptom severity more than classic GPM after one year of treatment?
  • Does GPM-extended lead to better outcomes in related clinical domains (e.g., personality functioning, emotional regulation, social functioning...) ? Researchers will compare two groups:
  • Patients treated in a center using the GPM-extended program.
  • Patients treated in a center using the classic GPM program. In each group, patients will receive weekly outpatient psychiatric care for one year. In terms of evaluation, patients will be evaluated at baseline, 4 months, 8 months, and 1 year. They will undergo both clinician-administered and self-report assessments to measure BPD symptoms and other relevant psychological dimensions. This study hopes to contribute to the development of dimensional evidence-based treatments for personality disorders.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
154

participants targeted

Target at P75+ for not_applicable

Timeline
43mo left

Started Jun 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress35%
Jun 2024Dec 2029

Study Start

First participant enrolled

June 19, 2024

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

March 31, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 6, 2025

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2029

Last Updated

April 9, 2025

Status Verified

March 1, 2025

Enrollment Period

5.5 years

First QC Date

March 31, 2025

Last Update Submit

April 7, 2025

Conditions

Keywords

Personality disorderborderline personality disordergood psychiatric managementpsychotherapydimensional

Outcome Measures

Primary Outcomes (1)

  • Change in BPD symptom severity (ZAN-BPD total score)

    Difference in mean change in total score on the Zanarini Rating Scale for Borderline Personality Disorder (ZAN-BPD), a clinician-rated instrument assessing the severity of borderline symptoms. Scores range from 0 to 36, with higher scores indicating greater severity of borderline symptoms.

    From baseline to 1 year.

Secondary Outcomes (21)

  • Change in BPD symptom dimensions (ZAN-BPD subscales)

    From baseline to 1 year.

  • Change in personality functioning (LPFS-BF)

    From baseline to 1 year.

  • Change in disability level (SDS)

    From baseline to 1 year.

  • Change in social functioning (QFS)

    From baseline to 1 year.

  • Change in suicidal and self-harming behaviors (SBBDM-S)

    From baseline to 1 year.

  • +16 more secondary outcomes

Study Arms (2)

GPM-Extended group (ADDIPSY, Lyon, France)

EXPERIMENTAL

Participants receive a one-year outpatient treatment based on GPM-extended, a dimensional adaptation of Good Psychiatric Management for BPD. It includes weekly 1-hour individual therapy focused on dominant personality dilemmas (abandonment, self-esteem, control), guided by structured clinical and psychometric assessment. Psychiatric case management (30 min every 3 weeks) addresses medication and coordination of care. Group components include at least one 6-week psychoeducation program (borderline, narcissistic, or obsessive-compulsive focus) and, for high emotion dysregulation, an 18-week DBT skills training group.

Behavioral: GPM-Extended

Classic GPM (Clinique CARADOC, Bayonne, France)

ACTIVE COMPARATOR

Participants receive a one-year outpatient treatment based on classic Good Psychiatric Management (GPM) for BPD. It includes weekly 1-hour individual therapy focused on interpersonal hypersensitivity, delivered by a GPM-trained therapist. Psychiatric case management (30 min every 3 weeks) addresses medication and coordination of care. Group interventions include a 6-week psychoeducation group on BPD and, for patients with high emotion dysregulation, an 18-week DBT skills training group.

Behavioral: Classic GPM

Interventions

GPM-ExtendedBEHAVIORAL

GPM-extended is a dimensional adaptation of Good Psychiatric Management (GPM) that retains its core principles-validation, real-life focus, alliance building-while enhancing flexibility and personalization. It emphasizes diagnostic clarity, treatment prioritization, and individualized psychoeducation based on three key personality dilemmas: fear of abandonment, self-esteem dysregulation, and control dependency. These dilemmas guide the focus of therapy and case management. Treatment goals are collaboratively set and regularly reassessed to align with the patient's evolving needs. The intervention includes weekly individual therapy and tailored group programs, with clinical strategies adapted to each dominant dilemma.

GPM-Extended group (ADDIPSY, Lyon, France)
Classic GPMBEHAVIORAL

The classic GPM group follows the validated and manualized version of Good Psychiatric Management (GPM) for BPD. It emphasizes symptom stabilization through weekly individual therapy and pragmatic case management every 3 weeks. Unlike GPM-extended, it uses a uniform therapeutic framework rather than tailoring treatment to individual personality dilemmas,.The intervention includes weekly individual therapy and standardized group programs, with clinical strategies applied uniformly across patients, centered on interpersonal hypersensitivity and building stable life roles.

Classic GPM (Clinique CARADOC, Bayonne, France)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults (≥18 years old)
  • Diagnosis of borderline personality disorder according to the SCID-II (≥5 out of 9 criteria)
  • Provision of written informed consent
  • Affiliated with or beneficiary of the French national health insurance system

You may not qualify if:

  • Age under 18 years
  • Presence of a comorbid psychotic disorder, intellectual disability, severe antisocial traits, major substance use disorder incompatible with intensive therapy without abstinence, anorexia nervosa with somatic risk, or bipolar disorder in acute manic phase
  • Individuals under legal protection (e.g., guardianship or legal safeguard)
  • Individuals unable to cooperate or complete self- or clinician-administered questionnaires
  • Individuals not affiliated with or not beneficiaries of the French national health insurance system

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Clinique Caradoc

Bayonne, 64100, France

RECRUITING

Addipsy

Lyon, 69007, France

RECRUITING

Related Publications (10)

  • Ridolfi ME, Rossi R, Occhialini G, Gunderson JG. A Clinical Trial of a Psychoeducation Group Intervention for Patients With Borderline Personality Disorder. J Clin Psychiatry. 2019 Dec 31;81(1):19m12753. doi: 10.4088/JCP.19m12753.

    PMID: 31917907BACKGROUND
  • McMain SF, Guimond T, Streiner DL, Cardish RJ, Links PS. Dialectical behavior therapy compared with general psychiatric management for borderline personality disorder: clinical outcomes and functioning over a 2-year follow-up. Am J Psychiatry. 2012 Jun;169(6):650-61. doi: 10.1176/appi.ajp.2012.11091416.

    PMID: 22581157BACKGROUND
  • McMain SF, Links PS, Gnam WH, Guimond T, Cardish RJ, Korman L, Streiner DL. A randomized trial of dialectical behavior therapy versus general psychiatric management for borderline personality disorder. Am J Psychiatry. 2009 Dec;166(12):1365-74. doi: 10.1176/appi.ajp.2009.09010039. Epub 2009 Sep 15.

    PMID: 19755574BACKGROUND
  • Blay M, Benmakhlouf I, Duarte M, Perroud N, Greiner C, Charbon P, Choi-Kain L, Speranza M. Case reports: Using Good Psychiatric Management (GPM) conceptualizations in the dimensional assessment and treatment of personality disorders. Front Psychiatry. 2023 Jul 26;14:1186524. doi: 10.3389/fpsyt.2023.1186524. eCollection 2023.

    PMID: 37564248BACKGROUND
  • Wright AGC, Ringwald WR, Hopwood CJ, Pincus AL. It's time to replace the personality disorders with the interpersonal disorders. Am Psychol. 2022 Dec;77(9):1085-1099. doi: 10.1037/amp0001087.

    PMID: 36595407BACKGROUND
  • Wright AG, Hopwood CJ, Skodol AE, Morey LC. Longitudinal validation of general and specific structural features of personality pathology. J Abnorm Psychol. 2016 Nov;125(8):1120-1134. doi: 10.1037/abn0000165.

    PMID: 27819472BACKGROUND
  • Sharp C, Wright AG, Fowler JC, Frueh BC, Allen JG, Oldham J, Clark LA. The structure of personality pathology: Both general ('g') and specific ('s') factors? J Abnorm Psychol. 2015 May;124(2):387-98. doi: 10.1037/abn0000033. Epub 2015 Mar 2.

    PMID: 25730515BACKGROUND
  • Bach B, Kramer U, Doering S, di Giacomo E, Hutsebaut J, Kaera A, De Panfilis C, Schmahl C, Swales M, Taubner S, Renneberg B. The ICD-11 classification of personality disorders: a European perspective on challenges and opportunities. Borderline Personal Disord Emot Dysregul. 2022 Apr 1;9(1):12. doi: 10.1186/s40479-022-00182-0.

    PMID: 35361271BACKGROUND
  • Hopwood CJ, Kotov R, Krueger RF, Watson D, Widiger TA, Althoff RR, Ansell EB, Bach B, Michael Bagby R, Blais MA, Bornovalova MA, Chmielewski M, Cicero DC, Conway C, De Clercq B, De Fruyt F, Docherty AR, Eaton NR, Edens JF, Forbes MK, Forbush KT, Hengartner MP, Ivanova MY, Leising D, John Livesley W, Lukowitsky MR, Lynam DR, Markon KE, Miller JD, Morey LC, Mullins-Sweatt SN, Hans Ormel J, Patrick CJ, Pincus AL, Ruggero C, Samuel DB, Sellbom M, Slade T, Tackett JL, Thomas KM, Trull TJ, Vachon DD, Waldman ID, Waszczuk MA, Waugh MH, Wright AGC, Yalch MM, Zald DH, Zimmermann J. The time has come for dimensional personality disorder diagnosis. Personal Ment Health. 2018 Feb;12(1):82-86. doi: 10.1002/pmh.1408. Epub 2017 Dec 11. No abstract available.

    PMID: 29226598BACKGROUND
  • Gunderson JG, Herpertz SC, Skodol AE, Torgersen S, Zanarini MC. Borderline personality disorder. Nat Rev Dis Primers. 2018 May 24;4:18029. doi: 10.1038/nrdp.2018.29.

    PMID: 29795363BACKGROUND

MeSH Terms

Conditions

Borderline Personality DisorderCompulsive Personality DisorderPersonality Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • Martin Blay, M.D., M.Sc

    AddiPsy

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Martin Blay, M.D., M.Sc

CONTACT

Frédéric Mazenod

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: The EPSYLIA study is a controlled, non-randomized, open-label trial using a "here-elsewhere" methodology (i.e., patient inclusion depends on the center to which each individual is referred).
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 31, 2025

First Posted

April 6, 2025

Study Start

June 19, 2024

Primary Completion (Estimated)

December 1, 2029

Study Completion (Estimated)

December 1, 2029

Last Updated

April 9, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will share

De-identified individual participant data (IPD) used in published analyses will be shared through the Open Science Framework (OSF) platform for each resulting publication. This includes the datasets used in the statistical analyses and the corresponding statistical code. A separate protocol paper will be published prior to the main outcome publications. Data and code will be made available to promote transparency and open science, following the publication of each study output.

Shared Documents
STUDY PROTOCOL, SAP, ANALYTIC CODE
Time Frame
The protocol paper will be published before the end of 2026. Other IPD and related materials will be made publicly available starting from the first publication of study results, for an indefinite period, to support transparency and open science.
Access Criteria
Access to data will be provided via a dedicated OSF link published alongside each article.

Locations