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

Not Applicable

Completed

• Conditions: Randomized Controlled Trial; Borderline Personality Disorder
• Interventions: Behavioral: Group Schema therapy; Behavioral: Individual Schema therapy

• Registration Number: NCT04211688
• Lead Sponsor: Consorci Sanitari del Maresme

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01-12
• Status Verified: 2019-12
• Primary Completion: 2019-12-01
• Study Completion: 2019-12-01
• Study First Submitted: 2019-12-19
• Study First Submitted QC: 2019-12-23
• Last Update Submitted: 2019-12-23
• Study First Posted: 2019-12-26
• Last Update Posted: 2019-12-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Combined individual + group Schema therapy	Individual Schema therapy	Those who will receive both individual plus group schema therapy
Combined individual + group Schema therapy	Group Schema therapy	Those who will receive both individual plus group schema therapy
Only group Schema therapy	Group Schema therapy	Those who will receive group schema therapy

Primary Outcome Measures

Name	Time	Method
BPD (borderline personality disorder) symptomatology	18 months	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).

Secondary Outcome Measures

Name	Time	Method
global functioning	18 months	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).
early maladaptive schemas	18 months	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).