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CompletedNCT04211688Updated Dec 26, 2019

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

An interventional study of Group Schema therapy and Individual Schema therapy in Borderline Personality Disorder and Randomized Controlled Trial, sponsored by Consorci Sanitari del Maresme. Completed. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2019-12-26.

Sponsored by Consorci Sanitari del Maresme · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 2 years 11 months after the study started (first participant enrolled Jan 2017, registered Dec 2019).
Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
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Study 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.

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Conditions studied

  • Borderline Personality Disorder
  • Randomized Controlled Trial
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In context

Personality Disorders

336 studies on the registry are indexed under Personality Disorders; 48 are open to participants now.

This study's enrollment of 80 is close to the median of 75 across 229 interventional studies indexed under Personality Disorders.

Browse Personality Disorders studies →

Lead sponsor

Consorci Sanitari del Maresme is the lead sponsor of 15 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
80 participants (actual)

Study arms

  • Experimental
    Combined individual + group Schema therapy

    Those who will receive both individual plus group schema therapy

    Behavioral: Group Schema therapy · Behavioral: Individual Schema therapy

  • Active comparator
    Only group Schema therapy

    Those who will receive group schema therapy

    Behavioral: Group Schema therapy

Interventions

  • BehavioralGroup Schema therapy

    Bimonthly outpatient psychotherapy delivered in individual setting

  • BehavioralIndividual Schema therapy

    weekly outpatient psychotherapy delivered in group setting

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What researchers measure

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).

    Time frame: 18 months

Secondary outcomes

  1. 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).

    Time frame: 18 months

  2. 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).

    Time frame: 18 months

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • 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. PubMed 19807718 ↗
  • 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.

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 26, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04211688
Lead sponsor
Consorci Sanitari del Maresme
Collaborators
Department of Health, Generalitat de Catalunya
Responsible party
Sponsor
First posted
Dec 26, 2019
Start date
Jan 12, 2017
Primary completion
Dec 1, 2019
Completion
Dec 1, 2019
Last update
Dec 26, 2019

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.

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