- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06913738
Evaluation of a Dimensional Adaptation of Good Psychiatric Management (GPM-extended) for the Treatment of Borderline Personality Disorder (EPSYLIA)
A Pragmatic Non-randomized Controlled Study Evaluating the Efficacy of a Dimensional Adaptation of Good Psychiatric Management (GPM-extended) Compared to a Classic Outpatient Good Psychiatric Management Treatment for Patient Fulfilling Criteria for Borderline Personality Disorder
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Personality disorders (PD) are among the most common psychiatric disorders, the most studied being borderline personality disorder (BPD), a disorder that affects approximately 1.6% of the general population and is characterised by significant difficulties in emotion regulation, identity and interpersonal relationships. Currently, categories of PD are criticised and many authors have highlighted the need for a more dimensional assessment of PD, using the association of a general factor (described as the level of personality functioning, assessed on personal and interpersonal functioning) with several personality traits used to describe specific personality characteristics (negative affectivity, antagonism/dissociality, detachment, disinhibition, anankastia, psychoticism). The two main models are the DSM-5 alternative personality disorder model (AMPD) and the International Classification of Diseases 11th edition personality disorder model (ICD-11). In particular, several works have suggested that the BPD criteria are one of the most important markers of general personality functioning. While these new models offer new and very exciting possibilities in terms of diagnostic assessment, they have struggled to spread across clinical services ; and, to date, no evidence-based treatments have been developed from these models, limiting their usefulness. Furthermore, these models are also limited by the nature of personality traits (Criteria B), as these represent rigid and stable patterns of dysfunction that may be difficult to represent the complex day-to-day fluctuations in internal psychic coherence and interpersonal functioning characteristic of PD.
One of the most recent treatments for BPD is Good Psychiatric Management. This has proved as effective as specialist therapies such as dialectical behaviour therapy and has also been developed for other personality disorders (notably narcissistic and obsessional-compulsive PD). Each adaptation is based on a specific conceptualisation designed to represent the main ways in which an individual may dysfunction in the personal and interpersonal domains. According to these conceptualisations, each of these three personality disorders presents a specific trigger for its difficulties: threat to relational dependence with fear of rejection and abandonment for borderline PD, threat to self-esteem for narcissistic PD, threat to ability to control for obsessive PD. Thus, some authors have suggested that the development of an adaptation of the GPM incorporating both the central aspects of the dimensional models, but also each of these different triggers in a non-exclusive manner (as they may be found to a greater or lesser extent in each patient suffering from PD), could be both feasible and useful, in particular to resolve the above-mentioned problems.
Indeed, like traditional dimensional models, GPM offers the possibility of a dimensional approach, with personality functioning assessed by the presence or absence of the BPD criteria, and features of personal and interpersonal dysfunction considered holistically using GPM's trigger-based approach. However, unlike traditional dimensional models, GPM has been empirically tested and found to be effective in treating patients who meet the criteria for BPD. In addition, it offers an approach to personality characteristics that is simpler, easier to understand, more accessible to psychoeducation and closer to patients' everyday experience than the personality traits classically used in dimensional models. In addition, although each adaptation of the GPM focuses on different PDs, much of the content remains the same: making and announcing the diagnosis, psychoeducation, case management, recurrent assessment of progress and reassessment if there is no response, multimodal approach including psychodynamic and behavioural psychotherapy, anticipation of crises, and management of symptomatic medication, etc. This may be linked to the fact that, although each disorder has specific triggers/traits, the underlying level of personality functioning is represented by BPD criteria and is therefore expected to be treated by the same psychotherapeutic content. Thus, a dimensional adaptation of GPM seems both relevant and feasible to address the problems of conventional dimensional models, namely the lack of existence of evidence-based treatments associated with these models, and the aspecific nature of personality trait-based approaches.
Altogether, we developed a dimensional adaptation of the GPM (GPM-extended), aiming to treat patients fulfilling the criteria for BPD dimensionally by incorporating elements from the adaptations for narcissistic and obsessional personality disorders. In terms of content, GPM-extended takes the common part of the treatment from the three adaptations and uses it as a basis, while also offering the possibility of constructing treatment goals and exposure targets that are much more specific to a given patient, in particular by carrying out an initial assessment and prioritisation of the various triggers. If this adaptation were to be shown to be effective, it would ultimately improve the diagnostic assessment and management of patients fulfilling BPD criteria, by offering treatment that is more tailored to each profile.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Martin Blay, M.D., M.Sc
- Phone Number: +33472943403
- Email: m.blay@addipsy.com
Study Contact Backup
- Name: Frédéric Mazenod
- Phone Number: +33472943403
- Email: f.mazenod@santebasque.fr
Study Locations
-
-
-
Bayonne, France, 64100
- Recruiting
- Clinique Caradoc
-
Contact:
- François Chevrier, M.D.
- Phone Number: +33559441744
- Email: f.chevrier@caradoc.fr
-
Contact:
- Linda Portilla
- Phone Number: +33559441744
- Email: dpo@caradoc.fr
-
Contact:
- François Chevrier, M.D.
-
Lyon, France, 69007
- Recruiting
- Addipsy
-
Contact:
- Martin Blay, M.D., M.Sc
- Phone Number: +33472943403
- Email: m.blay@addipsy.com
-
Contact:
- Frédéric Mazenod
- Phone Number: +33472943403
- Email: f.mazenod@santebasque.fr
-
Contact:
- Martin Blay, M.D., M.Sc
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion criteria
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: GPM-Extended group (ADDIPSY, Lyon, France)
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.
|
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.
|
|
Active Comparator: Classic GPM (Clinique CARADOC, Bayonne, France)
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in BPD symptom severity (ZAN-BPD total score)
Time Frame: From baseline to 1 year.
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in the frequency of personality disorder diagnoses (SCID-II)
Time Frame: From baseline to 1 year.
|
Comparison of the frequency of categorical personality disorder diagnoses using the SCID-II interview, an interviewer-rated diagnostic assessment of categorical personality disorders.
|
From baseline to 1 year.
|
|
Change in the frequency of current psychiatric comorbidities (MINI)
Time Frame: From baseline to 1 year.
|
Comparison of the frequency of psychiatric comorbidities assessed using the Mini International Neuropsychiatric Interview (MINI), an interviewer-rated diagnostic interview.
|
From baseline to 1 year.
|
|
Partial, full treatment response, and remission rates (ZAN-BPD)
Time Frame: From baseline to 1 year.
|
Rates of partial, full response, and remission based on change in ZAN-BPD scores, using criteria proposed by Ridolfi et al. (2019).
|
From baseline to 1 year.
|
|
Dropout rate during treatment year
Time Frame: From baseline to 1 year.
|
Number and percentage of participants who discontinued therapy before the end of the one-year program.
|
From baseline to 1 year.
|
|
Change in BPD symptom dimensions (ZAN-BPD subscales)
Time Frame: From baseline to 1 year.
|
Difference in mean change in ZAN-BPD subscale scores (affective, cognitive, impulsive, interpersonal), a clinician-rated instrument assessing the severity of borderline symptoms.
The subscores assess subdimensions of borderline psychopathology, and range from 0 to 8 (for cognitive, impulsive, and interpersonal subscores), and from 0 to 12 (for affective subscore only).
Higher scores indicating greater severity.
|
From baseline to 1 year.
|
|
Change in personality functioning (LPFS-BF)
Time Frame: From baseline to 1 year.
|
Change in total score and subscores (self and interpersonal functioning) on the Level of Personality Functioning Scale - Brief Form (LPFS-BF), a self-report tool assessing personality functioning impairment.
Scores range from 12 to 48 (for total score), and from 6 to 24 (for both subscores).
Higher scores indicates greater personality dysfunction.
|
From baseline to 1 year.
|
|
Change in disability level (SDS)
Time Frame: From baseline to 1 year.
|
Change in total and domain scores (work/school, social life, family life) on the Sheehan Disability Scale (SDS), a self-report measure of functional impairment.
Scores range from 0 to 30 (for total score), and from 0 to 10 (for each subscore).
Higher scores indicate greater disability.
|
From baseline to 1 year.
|
|
Change in social functioning (QFS)
Time Frame: From baseline to 1 year.
|
Change in frequency and satisfaction subscores on the Questionnaire de Fonctionnement Social (QFS), a self-report tool assessing social engagement and satisfaction.
Scores range from 8 to 40 for both subscores.
Higher scores indicate better social functioning.
|
From baseline to 1 year.
|
|
Change in suicidal and self-harming behaviors (SBBDM-S)
Time Frame: From baseline to 1 year.
|
Change in the number of self-reported suicide attempts and self-harming behaviors using the Suicidal Behavior and Body Damage & Modifications Scale (SBBDM-S), a self-report tool assessing lifetime prevalence and past number of suicidal behaviors and self-harming behaviors.
There are no score ranges.
The higher the score, the higher number of behaviors.
|
From baseline to 1 year.
|
|
Change in self-reported BPD symptom severity (BSL-23)
Time Frame: From baseline to 1 year.
|
Change in mean total score on the Borderline Symptom list 23 items, a self-report measure of borderline symptom severity.
Scores range from 0 to 4. Higher scores indicate greater severity of borderline symptoms.
|
From baseline to 1 year.
|
|
Change in narcissistic symptoms (PNI-B)
Time Frame: From baseline to 1 year.
|
Change in grandiose and vulnerable subscores on the Pathological Narcissism Inventory - Brief Form (PNI-B), a self-report tool assessing both grandiose and vulnerable pathological narcissism.
Both subscores range from 0 to 5. Higher scores indicate greater severity of narcissistic symptomatology.
|
From baseline to 1 year.
|
|
Change in obsessive-compulsive personality traits (POPS)
Time Frame: From baseline to 1 year.
|
Change in total score and subscores on the Pathological Obsessive-Compulsive Personality Scale (POPS), a self-report tool assessingobsessive-compulsive personality overall severity and specific traits, such as rigidity or perfectionism.
Total score range from 49 to 294, and subscores range from 15 to 90 for rigidity, from 7 to 42 for emotional over-control, from 12 to 72 for maladaptive perfectionnism, and from 8 to 48 for reluctance to delegate and difficulty with change.
Higher scores indicate greater severity of symptoms.
|
From baseline to 1 year.
|
|
Change in impulsivity levels (UPPS)
Time Frame: From baseline to 1 year.
|
Change in impulsivity scores using the original UPPS scale, a self-report tool assessing several dimensions of impulsivity (urgency, lack of premeditation, lack of perseverance, and sensation seeking).
Scores range from 12 to 48 for urgency and sensation seeking, from 11 to 44 for premeditation, and from 10 to 40 for perseverance.
Higher scores indicate greater impulsivity.
|
From baseline to 1 year.
|
|
Change in emotion dysregulation (DERS)
Time Frame: From baseline to 1 year.
|
Change in total score and subscores on the original version of the Difficulties in Emotion Regulation Scale (DERS), a self-report measure of emotional regulation difficulties.
Scores range from 36 to 180 (for total scores), from 6 to 30 (for awareness, acceptance, impulse control subscores), from 5 to 25 (for clarity and engagement subscores), and from 8 to 40 for strategies subscore.
Higher scores indicate greater emotion dysregulation.
|
From baseline to 1 year.
|
|
Change in alexithymia (TAS-20)
Time Frame: From baseline to 1 year.
|
Change in total score and subscores on the Toronto Alexithymia Scale - 20 items (TAS-20), a self-report tool assessing alexithymia (i.e., difficulty identifying and describing emotions).
Total score ranges from 20 to 100, identification subscore ranges from 7 to 35, description subscore ranges from 5 to 25, and exterior-oriented thoughts subscore ranges from 8 to 40.
Higher scores indicate greater severity of alexithymia.
|
From baseline to 1 year.
|
|
Change in mentalizing abilities (MentS)
Time Frame: From baseline to 1 year.
|
Change in total score and subscores on the Mentalization Scale (MentS), a self report tool assessing self-, other-mentalizing, and motivation to mentalize.
Scores range from 28 to 140 (for total score), from 8 to 40 (for self-mentalizing), and from 10 to 50 (for other-mentalizing and motivation to mentalize).
Higher score indicate better mentalizing abilities.
|
From baseline to 1 year.
|
|
Change in attachment style (ECR-R)
Time Frame: From baseline to 1 year.
|
Change in self-reported attachment anxiety and avoidance using the Experiences in Close Relationships-Revised (ECR-R) scale.
Mean scores range from 1 to 7 for both subscores.
Higher scores indicating higher attachment difficulties.
|
From baseline to 1 year.
|
|
Change in entitlement beliefs (PES)
Time Frame: From baseline to 1 year.
|
Change in score on the Psychological Entitlement Scale (PES), a self-report tool measuring entitlement (i.e., perceived deservingness and superiority).
Score ranges from 9 to 56.
Higher score indicates higher feelings of entitlement.
|
From baseline to 1 year.
|
|
Change in defense mechanisms (DMRS-SR-30)
Time Frame: From baseline to 1 year.
|
Change in defense mechanism patterns using the Defense Mechanism Rating Scale - Self Report (30 items).
Score ranges from 0 to 112 for raw defense score (RDS), with each of the 28 individual defense scores, each of the seven defense level scores, each of the defensive category scores, and each of the defenseive factor scores expressed as a proportion of the RDS ranging from 0% to 100%.
Moreover, the Overall Defensive Functioning score ranges from 1 to 7. Higher scores indicates higher use of defense mechanism.
|
From baseline to 1 year.
|
|
Change in therapeutic alliance (WAI-SR)
Time Frame: From baseline to 1 year.
|
Change in therapeutic alliance quality based on the Working Alliance Inventory - Self Report (WAI-SR), a self-report tool assessing therapeutic relationship using several dimensions (goal, task, and bond).
Score ranges from 12 to 60 for total score, and from 4 to 20 for each subscore.
Higher scores indicate better quality of the therapeutic relationship.
|
From baseline to 1 year.
|
|
Change in personality traits (PID-5-BF)
Time Frame: From baseline to 1 year.
|
Change in personality traits using the Personality Inventory for DSM-5 - Brief Form (PID-5-BF), a self-report tool assessing the five AMPD's maladaptive personality trait domains.
Total score ranges from 0 to 75, each global subscore ranges from 0 to 15, and each mean subscore ranges from to 0 to 3. Higher scores indicate higher presence e of personality traits.
|
From baseline to 1 year.
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Martin Blay, M.D., M.Sc, Addipsy
Publications and helpful links
General Publications
- 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.
- 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. Erratum In: Am J Psychiatry. 2010 Oct;167(10):1283.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2024-A00475-42
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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