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

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

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.

Study Overview

• Status: Completed
• Conditions: Borderline Personality Disorder; Randomized Controlled Trial
• Intervention / Treatment: Behavioral: Group Schema therapy; Behavioral: Individual Schema therapy

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Combined individual + group Schema therapy; Those who will receive both individual plus group schema therapy	Behavioral: Group Schema therapy; Bimonthly outpatient psychotherapy delivered in individual setting; Behavioral: Individual Schema therapy; weekly outpatient psychotherapy delivered in group setting
ACTIVE_COMPARATOR: Only group Schema therapy; Those who will receive group schema therapy	Behavioral: Group Schema therapy; Bimonthly outpatient psychotherapy delivered in individual setting

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Consorci Sanitari del Maresme
• Collaborators: Department of Health, Generalitat de Catalunya

Publications and helpful links

General Publications

• Zanarini MC. Psychotherapy of borderline personality disorder. Acta Psychiatr Scand. 2009 Nov;120(5):373-7. doi: 10.1111/j.1600-0447.2009.01448.x.
• Farrell, J. M., & Shaw, I. A. (2012). Group schema therapy for borderline personality disorder. A step-by-step treatment manual with patient workbook. West Sussex, UK: Wiley-Blackwell.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 12, 2017
• Primary Completion (ACTUAL): December 1, 2019
• Study Completion (ACTUAL): December 1, 2019

Study Registration Dates

• First Submitted: December 19, 2019
• First Submitted That Met QC Criteria: December 23, 2019
• First Posted (ACTUAL): December 26, 2019

Study Record Updates

• Last Update Posted (ACTUAL): December 26, 2019
• Last Update Submitted That Met QC Criteria: December 23, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Personality Disorders; Borderline Personality Disorder
• Other Study ID Numbers: 32/16

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No