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

NCT04211688 | Completed DMC

• 1 other identifier: 32/16
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Borderline Personality Disorder; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• global functioning

  18 months

• early maladaptive schemas

  18 months

Study Arms (2)

Combined individual + group Schema therapy

EXPERIMENTAL

Those who will receive both individual plus group schema therapy

Behavioral: Group Schema therapy; Behavioral: Individual Schema therapy

Only group Schema therapy

ACTIVE COMPARATOR

Those who will receive group schema therapy

Behavioral: Group Schema therapy

Interventions

Group Schema therapy BEHAVIORAL

Bimonthly outpatient psychotherapy delivered in individual setting

Combined individual + group Schema therapy; Only group Schema therapy

Individual Schema therapy BEHAVIORAL

weekly outpatient psychotherapy delivered in group setting

Combined individual + group Schema therapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• DSM-5 criteria for borderline personality disorder
• Aged 18 to 65 years

You may not qualify if:

• Psychotic disorders (except short, reactive psychotic episodes)
• Bipolar disorder (current hypo-manic or mixed episode)
• Antisocial personality disorder
• Substance intoxication
• Mental retardation

Sponsors & Collaborators

• Consorci Sanitari del Maresme: lead
• Department of Health, Generalitat de Catalunya: collaborator

Related Publications (2)

• 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.

  PMID: 19807718 RESULT

• 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.

  RESULT

MeSH Terms

Conditions

Borderline Personality Disorder

Condition Hierarchy (Ancestors)

Personality Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2019
• First Posted: December 26, 2019
• Study Start: January 12, 2017
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: December 26, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share