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

Borderline Personality Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04211688
• Other study ID #: 32/16
• Status: Completed
• Phase: N/A
• Start date: January 12, 2017
• Est. completion date: December 1, 2019

Study information

• Verified date: December 2019
• Source: Consorci Sanitari del Maresme
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: December 1, 2019
• Est. primary completion date: December 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Borderline Personality Disorder
• Personality Disorders
• Randomized Controlled Trial

Intervention

Behavioral:
• Group Schema therapy
Bimonthly outpatient psychotherapy delivered in individual setting
• Individual Schema therapy
weekly outpatient psychotherapy delivered in group setting

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Consorci Sanitari del Maresme	Department of Health, Generalitat de Catalunya

References & Publications (2)

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.

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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