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

NCT ID: NCT04211688

Last Updated: 2019-12-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-12
• Study Completion Date: 2019-12-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Combined individual + group Schema therapy

Those who will receive both individual plus group schema therapy

Group Type: EXPERIMENTAL

Group Schema therapy

Intervention Type: BEHAVIORAL

Bimonthly outpatient psychotherapy delivered in individual setting

Individual Schema therapy

Intervention Type: BEHAVIORAL

weekly outpatient psychotherapy delivered in group setting

Only group Schema therapy

Those who will receive group schema therapy

Group Type: ACTIVE_COMPARATOR

Group Schema therapy

Intervention Type: BEHAVIORAL

Bimonthly outpatient psychotherapy delivered in individual setting

Interventions

Group Schema therapy

Bimonthly outpatient psychotherapy delivered in individual setting

Intervention Type: BEHAVIORAL

Individual Schema therapy

weekly outpatient psychotherapy delivered in group setting

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Department of Health, Generalitat de Catalunya

OTHER_GOV

Sponsor Role: collaborator

Consorci Sanitari del Maresme

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

References

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.

Reference Type: RESULT

PMID: 19807718 (View on PubMed)

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.

Reference Type: RESULT

Other Identifiers

32/16

Identifier Type: -

Identifier Source: org_study_id