Borderline Personality DisorderNCT04211688
Effectiveness of a Combined Group-individual Schema Therapy for Borderline Personality Disorder
A study testing Group Schema therapy and Individual Schema therapy in people with Borderline Personality Disorder and Randomized Controlled Trial, run by Consorci Sanitari del Maresme.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Borderline Personality Disorder, Randomized Controlled Trial
- What is being tested?
- Group Schema therapy and Individual Schema therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 12 Jan 2017to 1 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- DSM-5 criteria for borderline personality disorder
- Aged 18 to 65 years
Who cannot join
- Psychotic disorders (except short, reactive psychotic episodes)
- Bipolar disorder (current hypo-manic or mixed episode)
- Antisocial personality disorder
- Substance intoxication
- Mental retardation
About this study
Official title: Real-world Effectiveness of a Combined Group-individual Schema Therapy for Borderline Personality Disorder: A Pragmatic Randomized Clinical Trial
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.
- Being tested
- Group Schema therapy, Individual Schema therapy
- Medical subject headings
- Borderline Personality Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group Schema therapyBehavioural
Bimonthly outpatient psychotherapy delivered in individual setting
Individual Schema therapyBehavioural
weekly outpatient psychotherapy delivered in group setting
| Study group | Role | What they receive |
|---|---|---|
| Combined individual + group Schema therapy | Experimental | Those who will receive both individual plus group schema therapy Receives: Behavioral: Group Schema therapy; Behavioral: Individual Schema therapy |
| Only group Schema therapy | Active comparator | Those who will receive group schema therapy Receives: Behavioral: Group Schema therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 18 months
Secondary outcomes (2)
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).
Measured: 18 months
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).
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2019
- Study start12 Jan 2017
- Primary completion1 Dec 2019
- Study completion1 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Borderline Personality DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Consorci Sanitari del Maresme
- Sponsor type
- University, hospital or other
- Collaborators
- Department of Health, Generalitat de Catalunya
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04211688
- Sponsor's protocol ID
- 32/16
- Status last verified
- Dec 2019
- First submitted
- 19 Dec 2019
- Last updated
- 26 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 19807718Farrell, 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.
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-world Effectiveness of a Combined Group-individual Schema Therapy for Borderline Personality Disorder: A Pragmatic Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04211688
- Acronym / sponsor ID
- 32/16
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Consorci Sanitari del MaresmeUniversity, hospital or other
- Collaborators
- Department of Health, Generalitat de Catalunya
- Study start
- 12 Jan 2017 (actual)
- Primary completion
- 1 Dec 2019 (actual)
- Study completion
- 1 Dec 2019 (actual)
- First posted
- 26 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Combined individual + group Schema therapy | Experimental | Behavioral: Group Schema therapy, Behavioral: Individual Schema therapyThose who will receive both individual plus group schema therapy |
| Only group Schema therapy | Active comparator | Behavioral: Group Schema therapyThose who will receive group schema therapy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- DSM-5 criteria for borderline personality disorder
- Aged 18 to 65 years
Key exclusion criteria (5 listed)
- Psychotic disorders (except short, reactive psychotic episodes)
- Bipolar disorder (current hypo-manic or mixed episode)
- Antisocial personality disorder
- Substance intoxication
- Mental retardation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group Schema therapyBimonthly outpatient psychotherapy delivered in individual setting | Behavioural | Combined individual + group Schema therapy, Only group Schema therapy |
| Individual Schema therapyweekly outpatient psychotherapy delivered in group setting | Behavioural | Combined individual + group Schema therapy |
Primary outcome
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).
2 secondary outcomes
global functioning
Time frame: 18 months
early maladaptive schemas
Time frame: 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2019.
- Results publication: PubMed 19807718Zanarini MC. Psychotherapy of borderline personality disorder. Acta Psychiatr Scand. 2009 Nov;120(5):373-7. doi: 10.1111/j.1600-0447.2009.01448.x.
- Results publicationFarrell, 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 dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Group Schema therapy and Individual Schema therapy in people with Borderline Personality Disorder and Randomized Controlled Trial, run by Consorci Sanitari del Maresme.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BPD (borderline personality disorder) symptomatology (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04211688, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2019.