Borderline Personality DisordersDBT+ContextNCT05972096
DBT Skills Expanded With Contextual Intervention for Long Lasting Symptoms in Borderline Personality Disorder
A study testing Combination DBT, self-compassion and contextual-based skills in people with Borderline Personality Disorders and BPD, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
Trial summary
Although borderline personality disorder (BPD) tend to the clinical remission in long-term follow-up studies, a significant subgroup of patients continues to present long lasting symptoms such as low mood, emptiness and persistent impairment in psychosocial adjustment. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Borderline Personality Disorders, BPD
- What is being tested?
- Combination DBT, self-compassion and contextual-based skills
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- 1 Mar 2022to 1 Oct 2023
- 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
- Adults between 18 and 65 years of age
- Primary diagnosis of BPD according to Diagnostic Statistical Manual IV criteria and by the structured interviews: Diagnosis Structured clinical interview for axis II personality disorders (SCID II; First et al. 1997) and Diagnostic Interview for Borderlines Revised (DIB-R)
- Previous participation in DBT-ST intervention
- Signed informed consent.
Who cannot join
- Presence of life-threatening behaviors in the last 12 months
- PTSD or related symptoms
- Diagnosis of drug-induced psychosis, organic brain syndrome, bipolar or psychotic disorder
- Intellectual disability
- Participation in any other psychotherapy treatment during the study.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Juan Carlos Pascual Mateos
Barcelona, 08041
Juan Carlos Pascual, PhD, +34935537840, jpascual@santpau.cat
About this study
Official title: Clinical Trial of Skills Training for Long Lasting Symptoms in Borderline Personality Disorder
Although borderline personality disorder (BPD) tend to the clinical remission in long-term follow-up studies, a significant subgroup of patients continues to present long lasting symptoms such as low mood, emptiness and persistent impairment in psychosocial adjustment. The prevalence of this subsample of individuals is considerably increasing last years. New interventions addressed to these individuals are need, the aim of this study is to evaluate the efficacy of a novel intervention combining dialectical behavioral therapy skills training with self-compassion and contextual-based skills for patients with long-lasting BPD.
Read the detailed description
Sixty individuals with BPD and long lasting symptoms that have been received previously dialectical-behavioral therapy skills training (DBT-ST) will be included in a randomized clinical trial. They will be randomly assigned to receive an add-on skills training intervention involving the combination of DBT-ST, self-compassion, and contextual-based skills for long lasting symptoms versus treatment as usual during 12-weeks. Patients will be evaluated pre and post intervention and 3-month follow-up. The outcome measures are well-being indicators and clinical variables.
- Conditions
- Borderline Personality Disorders, BPD
- Being tested
- Combination DBT, self-compassion and contextual-based skills
- Keywords
- borderline personality disorder, long-lasting symptoms, dialectical behavior therapy skills, contextual approach.
- 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.
Combination DBT, self-compassion and contextual-based skillsBehavioural
Psychotherapy combination. Skills of DBT plus self-compassion and contextual skills
| Study group | Role | What they receive |
|---|---|---|
| Combination of DBT-ST, self-compassion, and contextual-based skills. | Experimental | Combination of DBT-ST, self-compassion, and contextual-based skills. Receives: Behavioral: Combination DBT, self-compassion and contextual-based skills |
| Control Group | Placebo comparator | Treatment as usual. Although these individuals did not receive any new specific psychotherapeutic intervention for BPD, they valued the higher frequency of psychiatric visits, attention in crisis, family care, and greater experience and sensitivity in the management of BPD. Receives: Behavioral: Combination DBT, self-compassion and contextual-based skills |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pemberton Happiness Index (PHI)
Happiness index (minimum 0- maximum 110) Higher scores better
Measured: 1 month
Secondary outcomes (6)
Borderline Symptoms List-23 (BSL-23)
Symptoms of Borderline (minimum 0- maximum 92). Higher scores worse
Measured: 1 week
Remission from Depression Questionnaire (RDQ)
Depression (minimum 0- maximum 84). Higher scores worse
Measured: 1 week
Self Compassion Scale Short Form (SCS-SF)
Compassion scale (12 items, minimum 12- maximum 60). Higher scores worse
Measured: 1 month
Forms of Self-Criticism/Self-Attacking and Self-Reassuring Scale (FSCRS)
Self-criticism forms (14 items, minimum 0- maximum 56). Higher scores worse
Measured: 1 month
Satisfaction with life scale (SWLS)
Well being (5 items, minimum 5 - maximum 25). Higher scores better
Measured: 1 month
Quality of life scale (WHO-QOL_BREF)
Quality of life OMS (26 items, minimum 26- maximum 130). Higher scores better
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2023
- Study start1 Mar 2022
- Primary completion1 Oct 2023 (estimated)
- Study completion1 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Borderline Personality DisordersStudies 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
- Model description
- Randomized clinical trial aims to test the efficacy of this expanded skills DBT-based intervention with self-compassion and contextual-based skills targeting long-lasting BPD compared with treatment as usual.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joaquim Soler, PhD, Principal investigator, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05972096
- Sponsor's protocol ID
- IIBSP-TLP-2020-104
- Acronym
- DBT+Context
- Status last verified
- Jul 2023
- First submitted
- 17 Jul 2023
- Last updated
- 2 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial of Skills Training for Long Lasting Symptoms in Borderline Personality Disorder
- ClinicalTrials.gov ID
- NCT05972096
- Acronym / sponsor ID
- DBT+Context / IIBSP-TLP-2020-104
- Conditions
- Borderline Personality Disorders, BPD
- Keywords
- borderline personality disorder, long-lasting symptoms, dialectical behavior therapy skills, contextual approach.
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 1 Oct 2023 (estimated)
- Study completion
- 1 Oct 2023 (estimated)
- First posted
- 2 Aug 2023 (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.
Although borderline personality disorder (BPD) tend to the clinical remission in long-term follow-up studies, a significant subgroup of patients continues to present long lasting symptoms such as low mood, emptiness and persistent impairment in psychosocial adjustment. The prevalence of this subsample of individuals is considerably increasing last years. New interventions addressed to these individuals are need, the aim of this study is to evaluate the efficacy of a novel intervention combining dialectical behavioral therapy skills training with self-compassion and contextual-based skills for patients with long-lasting BPD.
Detailed description
Sixty individuals with BPD and long lasting symptoms that have been received previously dialectical-behavioral therapy skills training (DBT-ST) will be included in a randomized clinical trial. They will be randomly assigned to receive an add-on skills training intervention involving the combination of DBT-ST, self-compassion, and contextual-based skills for long lasting symptoms versus treatment as usual during 12-weeks. Patients will be evaluated pre and post intervention and 3-month follow-up. The outcome measures are well-being indicators and clinical variables.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Randomized clinical trial aims to test the efficacy of this expanded skills DBT-based intervention with self-compassion and contextual-based skills targeting long-lasting BPD compared with treatment as usual.
| Arm | Type | Receives |
|---|---|---|
| Combination of DBT-ST, self-compassion, and contextual-based skills. | Experimental | Behavioral: Combination DBT, self-compassion and contextual-based skillsCombination of DBT-ST, self-compassion, and contextual-based skills. |
| Control Group | Placebo comparator | Behavioral: Combination DBT, self-compassion and contextual-based skillsTreatment as usual. Although these individuals did not receive any new specific psychotherapeutic intervention for BPD, they valued the higher frequency of psychiatric visits, attention in crisis, family care, and greater experience and sensitivity in the management of BPD. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults between 18 and 65 years of age
- Primary diagnosis of BPD according to Diagnostic Statistical Manual IV criteria and by the structured interviews: Diagnosis Structured clinical interview for axis II personality disorders (SCID II; First et al. 1997) and Diagnostic Interview for Borderlines Revised (DIB-R)
- Previous participation in DBT-ST intervention
- Signed informed consent.
Key exclusion criteria (5 listed)
- Presence of life-threatening behaviors in the last 12 months
- PTSD or related symptoms
- Diagnosis of drug-induced psychosis, organic brain syndrome, bipolar or psychotic disorder
- Intellectual disability
- Participation in any other psychotherapy treatment during the study.
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 |
|---|---|---|
| Combination DBT, self-compassion and contextual-based skillsPsychotherapy combination. Skills of DBT plus self-compassion and contextual skills | Behavioural | Combination of DBT-ST, self-compassion, and contextual-based skills., Control Group |
Primary outcome
Pemberton Happiness Index (PHI)
Time frame: 1 month
Happiness index (minimum 0- maximum 110) Higher scores better
6 secondary outcomes
Borderline Symptoms List-23 (BSL-23)
Time frame: 1 week
Remission from Depression Questionnaire (RDQ)
Time frame: 1 week
Self Compassion Scale Short Form (SCS-SF)
Time frame: 1 month
Forms of Self-Criticism/Self-Attacking and Self-Reassuring Scale (FSCRS)
Time frame: 1 month
Satisfaction with life scale (SWLS)
Time frame: 1 month
Quality of life scale (WHO-QOL_BREF)
Time frame: 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2023.
- 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.
Joaquim Soler, PhD principal investigator
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Combination DBT, self-compassion and contextual-based skills in people with Borderline Personality Disorders and BPD, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
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 4 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: status not confirmed, as of the sponsor's last update on 2 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Juan Carlos Pascual, PhD (34935537840, jpascual@santpau.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pemberton Happiness Index (PHI) (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Aug 2023.