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

• Sponsor: Consorci Sanitari del Maresme (Other)
• Overall Status: Completed
• CT.gov ID: NCT04211688
• Collaborator: Department of Health, Generalitat de Catalunya (Other)
• Enrollment: 80
• Arms: 2
• Actual Duration (Months): 34.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Borderline Personality Disorder; Randomized Controlled Trial	Behavioral: Group Schema therapy; Behavioral: Individual Schema therapy	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Treatment
• Official Title: Real-world Effectiveness of a Combined Group-individual Schema Therapy for Borderline Personality Disorder: A Pragmatic Randomized Clinical Trial
• Actual Study Start Date: Jan 12, 2017
• Actual Primary Completion Date: Dec 1, 2019
• Actual Study Completion Date: Dec 1, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

1. 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).

2. 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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Consorci Sanitari del Maresme
• ClinicalTrials.gov Identifier: NCT04211688
• Other Study ID Numbers: 32/16
• First Posted: Dec 26, 2019
• Last Update Posted: Dec 26, 2019
• Last Verified: Dec 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Personality Disorders; Borderline Personality Disorder

Study Results

No Results Posted as of Dec 26, 2019