Effectiveness of a Combined Group-individual Schema Therapy for Borderline Personality Disorder

Study Overview
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Brief Summary
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Background and Objectives: Schema therapy has been shown to be of benefit in treating borderline personality disorder. However, it is still unclear what the most suitable treatment implementation format is and to what extent therapeutic gains may be generalizable to regular healthcare settings with limited resources. Methods: A pragmatic randomized controlled trial was conducted ona representative Spanish sample of outpatients with a DSM-5 main diagnosis of borderline personality disorder. Patients were allocated either to a combined (group plus individual) schema therapy format (n=40) or to a group-only schema therapy format (n=40). Borderline personality disorder severity was the primary outcome, with other clinical variables considered as secondary outcomes (e.g., early maladaptive schemas, functioning). The assessment protocol included baseline, post-treatment (after 12months of treatment), and six-month follow-up evaluations. Data was analyzed through a two-way repeated measures ANOVA. Limitations were a limited follow-up assessment and the absence of multi-center data that detracted from the long-term stability and generalizability of the findings.

Official Title
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Real-world Effectiveness of a Combined Group-individual Schema Therapy for Borderline Personality Disorder: A Pragmatic Randomized Clinical Trial

Conditions
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Borderline Personality Disorder, Randomized Controlled Trial

Intervention / Treatment
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* Behavioral: Group Schema therapy
* Behavioral: Individual Schema therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: DSM-5 criteria for borderline personality disorder Aged 18 to 65 years Exclusion Criteria: Psychotic disorders (except short, reactive psychotic episodes) Bipolar disorder (current hypo-manic or mixed episode) Antisocial personality disorder Substance intoxication Mental retardation

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Combined individual + group Schema therapy<br>Those who will receive both individual plus group schema therapy | Behavioral: Group Schema therapy<br>* Bimonthly outpatient psychotherapy delivered in individual setting<br>Behavioral: Individual Schema therapy<br>* weekly outpatient psychotherapy delivered in group setting<br>|
| Active Comparator: Only group Schema therapy<br>Those who will receive group schema therapy | Behavioral: Group Schema therapy<br>* Bimonthly outpatient psychotherapy delivered in individual setting<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BPD (borderline personality disorder) symptomatology | Severity of borderline symptomatology as measured by a single score from the BSL-23 scale (range: 0-92; the higher the score, the more severe the BPD severity). | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| global functioning | Severity of dysfunction as measured by a single score from the WHOQoL scale (range: 0-100; the higher the score, the more severe the global dysfunction). | 18 months | 
| early maladaptive schemas | Severity of maladaptive schemas as measured by a single score from the YSQ scale (range: 0-450; the higher the score, the more severe the EMS severity). | 18 months |