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OpenTrials
Completed

NCT Number: NCT04211688

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Group schema therapy

Behavioral

Bimonthly outpatient psychotherapy delivered in individual setting

Individual Schema therapy

Behavioral

weekly outpatient psychotherapy delivered in group setting

Primary outcomes

  1. BPD (borderline personality disorder) symptomatology

    Time frame: 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 outcomes

  1. global functioning

    Time frame: 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

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Consorci Sanitari del Maresme

Other

Collaborators

  • Department of Health, Generalitat de Catalunya

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Dec 26, 2019
Registry last updated
Dec 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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