Borderline Personality DisorderMAP-DBTNCT04626310
Mapping Aspects of Psychotherapy in Dialectical Behavior Therapy
A study testing Dialectical behavior therapy - emotion regulation skills training, Dialectical behavior therapy - interpersonal effectiveness skills training and Interpersonal psychotherapy in people with Borderline Personality Disorder, run by University of Massachusetts, Amherst at 1 site in United States.
Trial summary
Although dialectical behavior therapy (DBT) skills training is effective in the treatment of borderline personality disorder, it contains four skills modules and there is little research to guide their modular application. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Borderline Personality Disorder
- What is being tested?
- Dialectical behavior therapy - emotion regulation skills training, Dialectical behavior therapy - interpersonal effectiveness skills training and Interpersonal psychotherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Oct 2020to 6 Feb 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- exhibit 4+ BPD symptoms,
- have a history of recent (i.e., past-year) and recurrent (> 1 instance) of self-injury,
- commit to participate in one of our 6-week experimental groups,
- have an individual health provider who can manage imminent issues,
- be between 18-60 years old,
Who cannot join
- not fluent in English,
- have impaired (uncorrected) vision or hearing that would impair ability to understand study stimuli,
- a current manic, psychotic, or active physiological dependence on substances (to limit interference in the lab),
- low cognitive functioning (IQ ≤ 70.4 (TOPF; Pearson Assessments, 2009),
- past DBT treatment
Trial locations and contacts
1 site in 1 country.
United States1 site
Psychological Services Center, University of Massachusetts Amherst
Amherst, Massachusetts, 01002
About this study
Official title: Mapping Treatment Components to Targets in Dialectical Behavior Therapy
Although dialectical behavior therapy (DBT) skills training is effective in the treatment of borderline personality disorder, it contains four skills modules and there is little research to guide their modular application. This study compares the unique effects of two distinct DBT skills training modules, relative to a non-DBT therapy group for adults with borderline personality disorder. Using innovative laboratory-based assessment methods, the proposed study will examine the effects of these conditions on emotional responding and interpersonal functioning, as well as clinical outcomes.
Read the detailed description
Borderline personality disorder (BPD) is a severe mental health condition with high morbidity and mortality. Although dialectical behavior therapy (DBT) is an efficacious treatment for BPD, it is resource-intensive and lengthy in its full form, involving one year of weekly individual therapy and group skills training in mindfulness, emotion regulation, interpersonal effectiveness, and distress tolerance. As a result, few patients have access to the full treatment. A better understanding of how the distinct components of DBT affect different sets of symptoms could help to streamline this treatment and personalize its use with specific patients.
Improvements in both interpersonal and emotional functioning are theorized to underlie improvements in BPD. Thus, emotion regulation and interpersonal effectiveness skills training may be particularly important components of DBT. Therefore, this study examines the unique effects of two distinct DBT skills training modules.
Participants are adults with BPD and recent, recurrent self-injurious behaviors (planned N = 81) who are randomly assigned to six weeks of DBT emotion regulation skills training (DBT-ER), DBT interpersonal effectiveness skills training (DBT-IE), or a non-skills control group. Using innovative laboratory-based multimethod assessments, this study examines the effects of these conditions on emotional responding and interpersonal functioning, as well as BPD related outcomes. Aim 1 examines the unique effects of DBT-ER and DBT-IE on their respective emotion-related (subjective and biological emotional reactivity, behavioral emotion regulation, skills use) and interpersonal (subjective and behavioral) targets, compared to the non-DBT treatment. Aim 2 examines whether improved emotional functioning predicts reductions in BPD symptoms and self-injury. Aim 3 examines whether baseline emotion dysregulation interacts with treatment condition to predict treatment response.
The proposed research is innovative in its experimental examination of the effects of DBT components on specific targets in BPD. Given the high societal costs of BPD, this work has important public health significance. Findings will inform larger studies evaluating the potential modular use of DBT components to result in briefer and more efficient individualized treatments for patients.
- Conditions
- Borderline Personality Disorder
- Being tested
- Dialectical behavior therapy - emotion regulation skills training, Dialectical behavior therapy - interpersonal effectiveness skills training, Interpersonal psychotherapy
- Keywords
- Dialectical behavior therapy, Emotions, Behavior and Behavior mechanisms, Randomized Controlled Trials
- Medical subject headings
- Borderline Personality Disorder, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dialectical behavior therapy - emotion regulation skills trainingBehavioural
Arm 1. Dialectical behavior therapy - emotion regulation skills training follows the emotion regulation skills DBT Skills Training Manual Second Edition and the DBT Skills Training Handouts and Worksheets Second Edition. This group involves 6 weekly sessions.
Arm 2. Dialectical behavior therapy - interpersonal effectiveness skills training follows the interpersonal effectiveness skills DBT Skills Training Manual Second Edition and the DBT Skills Training Handouts and Worksheets Second Edition. This group involves 6 weekly sessions.
Dialectical behavior therapy - interpersonal effectiveness skills trainingBehavioural
Arm 2. Dialectical behavior therapy - interpersonal effectiveness skills training follows the interpersonal effectiveness skills DBT Skills Training Manual Second Edition and the DBT Skills Training Handouts and Worksheets Second Edition. This group involves 6 weekly sessions.
Interpersonal psychotherapyBehavioural
Arm 3. Non-skills-oriented interpersonal psychotherapy group follows evidence-based principles on common factors in a group therapy context. This group involves 6 weekly sessions.
| Study group | Role | What they receive |
|---|---|---|
| Dialectical behavior therapy - emotion regulation skills training | Experimental | Dialectical behavior therapy - emotion regulation skills training Receives: Behavioral: Dialectical behavior therapy - emotion regulation skills training |
| Dialectical behavior therapy - interpersonal effectiveness skills training | Experimental | Dialectical behavior therapy - interpersonal effectiveness skills training Receives: Behavioral: Dialectical behavior therapy - interpersonal effectiveness skills training |
| Non-skills-oriented interpersonal psychotherapy group | Active comparator | Non-skills-oriented interpersonal psychotherapy group Receives: Behavioral: Interpersonal psychotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Emotional Functioning - Linear
Assessed with the Difficulties in Emotion Regulation Scale (DERS), which has total scores that range from 36-180, with higher scores indicating more difficulties. Outcomes are reported as slopes (scores over weeks, centered around the start of treatment, with standard errors) per condition, extracted from mixed effects/multilevel models. This measure is listed separately to permit presentation of two units of measure (that are in the same model) - the Linear unit of measure (DERS scores/week), and the Quadratic unit of measure (DERS scores/week^2). This measure reflects the Linear measure.
Measured: Pre-treatment, mid-treatment week 3-4, post-treatment week 6-7, follow-up week 13-14
Change in Borderline Personality Disorder Features - Linear
Assessed with the abbreviated Borderline Symptom List (BSL23), which has mean scores that range from 0-4, with higher scores indicating more symptoms. Outcomes are reported as slopes (scores rescaled *100 over weeks, centered around the start of treatment, with standard errors) per condition, extracted from mixed effects/multilevel models. This measure is listed separately to permit presentation of two units of measure (that are in the same model) - the Linear unit of measure (BSL scores/week), and the Quadratic unit of measure (BSL scores/week^2). This measure reflects the Linear measure.
Measured: Pre-treatment, mid-treatment week 3-4, post-treatment week 6-7, follow-up week 13-14
Change in Emotional Functioning - Quad
Assessed with the Difficulties in Emotion Regulation Scale (DERS), which has total scores that range from 36-180, with higher scores indicating more difficulties. Outcomes are reported as slopes (scores over weeks, centered around the start of treatment, with standard errors) per condition, extracted from mixed effects/multilevel models. This measure is listed separately to permit presentation of two units of measure (that are in the same model) - the Linear unit of measure (DERS scores/week), and the Quadratic unit of measure (DERS scores/week^2). This measure reflects the Quadratic measure.
Measured: Pre-treatment, mid-treatment week 3-4, post-treatment week 6-7, follow-up week 13-14
Change in Borderline Personality Disorder Features - Quad
Assessed with the abbreviated Borderline Symptom List (BSL23), which has mean scores that range from 0-4, with higher scores indicating more symptoms. Outcomes are reported as slopes (scores rescaled *100 over weeks, centered around the start of treatment, with standard errors) per condition, extracted from mixed effects/multilevel models. This measure is listed separately to permit presentation of two units of measure (that are in the same model) - the Linear unit of measure (BSL scores/week), and the Quadratic unit of measure (BSL scores/week^2). This measure reflects the Quadratic measure.
Measured: Pre-treatment, mid-treatment week 3-4, post-treatment week 6-7, follow-up week 13-14
Secondary outcomes (6)
Change in Self-reported Emotional Reactivity
Assessed with self-reported emotions on the PANAS negative affect (NA) scale (mean scores on a scale of 1-5) in response to emotional scripts (Neg: neutral (Neu), negative (Neg)) by emotion regulation condition (Reg: emotional maintain instructions, and negative with decrease instructions) presented in the lab. Outcomes are reported as slopes differences in PANAS NA scores between neutral and negative-maintain over weeks (centered around the start of treatment, with standard errors) per condition, extracted from mixed effects/multilevel models.
Measured: Pre-treatment, mid-treatment week 3-4, post-treatment week 6-7
Change in Self-reported Emotional Regulation
Assessed with self-reported emotions on the PANAS negative affect (NA) scale (mean scores on a scale of 1-5) in response to emotional scripts (neutral (Neu), negative (Neg)) by emotion regulation condition (Reg: with emotional maintain (Main) instructions, and negative with decrease (Dec) instructions) presented in the lab. Outcomes are reported as slopes differences in PANAS NA scores between Reg conditions in response to negative stimuli (negative-decrease and negative-maintain) over weeks (centered around the start of treatment, with standard errors) per condition, extracted from mixed effects/ multilevel models.
Measured: Pre-treatment, mid-treatment week 3-4, post-treatment week 6-7
Change in Affect-modulated Startle
Assessed with eyeblink startle amplitude (mV) in response to emotional cues presented in the lab (of note, per protocol, we examined eyeblink in response to negative and neutral image stimuli across initial [novel] and repeated presentations) which were presented along with sound bursts to elicit startle. This outcome was transformed and then rescaled (*100, = mVtr). Outcomes are reported as slopes per condition over weeks (centered around the start of treatment, with standard errors) per condition, extracted from mixed effects/multilevel models with image valence (Neg: negative vs. neutral) and type (Novel: novel vs. repeated) within-person condition effects.
Measured: Pre-treatment, mid-treatment week 3-4, post-treatment week 6-7
Change in Emotional Habituation
Assessed with skin conductance (SC; microsiemens, μS) in response to emotional cues presented in the lab (of note, per protocol, we examined DV in response to negative and neutral image stimuli [Neg] across initial [Novel] and repeated presentations) which were presented along with sound bursts to elicit startle. Data were transformed to address skew (μStr). Outcomes are reported as novel x negative slopes (SLP) over weeks (centered around the start of treatment, with standard errors) per condition, extracted from mixed effects / multilevel models.
Measured: Pre-treatment, mid-treatment week 3-4, post-treatment week 6-7
Change in Physiological Emotional Reactivity
Assessed with skin conductance (SC; microsiemens, μS) in response to emotional scripts (Neg: neutral, negative) by emotion regulation (Reg: emotional maintain instructions, and negative with decrease instructions) presented in the lab. Data were transformed to address skew (μStr). Outcomes are reported as slopes of Negative (Neg) condition effects on SC over weeks (centered around the start of treatment, with standard errors) per condition, extracted from mixed effects / multilevel models.
Measured: Pre-treatment, mid-treatment week 3-4, post-treatment week 6-7
Change in Deliberate Physiological Emotional Regulation
Assessed with high frequency heart rate variability (HRV, ms2/hz) in response to emotional scripts (Negative: negative vs. neutral) with emotion regulation instructions (Reg: Maintain vs. Decrease in the Negative condition) presented in the lab. Data were transformed to address skew (ms2/hztr). Outcomes are reported as slopes of the effect of the Reg condition on HRV over weeks (centered around the start of treatment, with standard errors) per condition, extracted from mixed effects /multilevel models.
Measured: Pre-treatment, mid-treatment week 3-4, post-treatment week 6-7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2020
- Study start26 Oct 2020
- Primary completion6 Feb 2023
- Study completion6 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Amherst
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), University of Toledo
- Responsible party
- Principal investigator, Katherine Dixon-Gordon, University of Massachusetts, Amherst
- Investigators
- Katherine L Dixon-Gordon, PhD, Principal investigator, University of Massachusetts, Amherst
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04626310
- Sponsor's protocol ID
- 1710 1R21MH119530-01A1
- Other IDs
- R21MH119530-01A1
- Acronym
- MAP-DBT
- Status last verified
- Nov 2024
- First submitted
- 1 Nov 2020
- Last updated
- 27 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be shared via NDA.
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mapping Treatment Components to Targets in Dialectical Behavior Therapy
- ClinicalTrials.gov ID
- NCT04626310
- Acronym / sponsor ID
- MAP-DBT / 1710 1R21MH119530-01A1
- Conditions
- Borderline Personality Disorder
- Keywords
- Dialectical behavior therapy, Emotions, Behavior and Behavior mechanisms, Randomized Controlled Trials
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- University of Massachusetts, AmherstUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), University of Toledo
- Study start
- 26 Oct 2020 (actual)
- Primary completion
- 6 Feb 2023 (actual)
- Study completion
- 6 Feb 2023 (actual)
- First posted
- 12 Nov 2020 (actual)
- Results
- Posted 27 Nov 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Although dialectical behavior therapy (DBT) skills training is effective in the treatment of borderline personality disorder, it contains four skills modules and there is little research to guide their modular application. This study compares the unique effects of two distinct DBT skills training modules, relative to a non-DBT therapy group for adults with borderline personality disorder. Using innovative laboratory-based assessment methods, the proposed study will examine the effects of these conditions on emotional responding and interpersonal functioning, as well as clinical outcomes.
Detailed description
Borderline personality disorder (BPD) is a severe mental health condition with high morbidity and mortality. Although dialectical behavior therapy (DBT) is an efficacious treatment for BPD, it is resource-intensive and lengthy in its full form, involving one year of weekly individual therapy and group skills training in mindfulness, emotion regulation, interpersonal effectiveness, and distress tolerance. As a result, few patients have access to the full treatment. A better understanding of how the distinct components of DBT affect different sets of symptoms could help to streamline this treatment and personalize its use with specific patients.
Improvements in both interpersonal and emotional functioning are theorized to underlie improvements in BPD. Thus, emotion regulation and interpersonal effectiveness skills training may be particularly important components of DBT. Therefore, this study examines the unique effects of two distinct DBT skills training modules.
Participants are adults with BPD and recent, recurrent self-injurious behaviors (planned N = 81) who are randomly assigned to six weeks of DBT emotion regulation skills training (DBT-ER), DBT interpersonal effectiveness skills training (DBT-IE), or a non-skills control group. Using innovative laboratory-based multimethod assessments, this study examines the effects of these conditions on emotional responding and interpersonal functioning, as well as BPD related outcomes. Aim 1 examines the unique effects of DBT-ER and DBT-IE on their respective emotion-related (subjective and biological emotional reactivity, behavioral emotion regulation, skills use) and interpersonal (subjective and behavioral) targets, compared to the non-DBT treatment. Aim 2 examines whether improved emotional functioning predicts reductions in BPD symptoms and self-injury. Aim 3 examines whether baseline emotion dysregulation interacts with treatment condition to predict treatment response.
The proposed research is innovative in its experimental examination of the effects of DBT components on specific targets in BPD. Given the high societal costs of BPD, this work has important public health significance. Findings will inform larger studies evaluating the potential modular use of DBT components to result in briefer and more efficient individualized treatments for patients.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dialectical behavior therapy - emotion regulation skills training | Experimental | Behavioral: Dialectical behavior therapy - emotion regulation skills trainingDialectical behavior therapy - emotion regulation skills training |
| Dialectical behavior therapy - interpersonal effectiveness skills training | Experimental | Behavioral: Dialectical behavior therapy - interpersonal effectiveness skills trainingDialectical behavior therapy - interpersonal effectiveness skills training |
| Non-skills-oriented interpersonal psychotherapy group | Active comparator | Behavioral: Interpersonal psychotherapyNon-skills-oriented interpersonal psychotherapy group |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- exhibit 4+ BPD symptoms,
- have a history of recent (i.e., past-year) and recurrent (> 1 instance) of self-injury,
- commit to participate in one of our 6-week experimental groups,
- have an individual health provider who can manage imminent issues,
- be between 18-60 years old,
Key exclusion criteria (5 listed)
- not fluent in English,
- have impaired (uncorrected) vision or hearing that would impair ability to understand study stimuli,
- a current manic, psychotic, or active physiological dependence on substances (to limit interference in the lab),
- low cognitive functioning (IQ ≤ 70.4 (TOPF; Pearson Assessments, 2009),
- past DBT treatment
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 |
|---|---|---|
| Dialectical behavior therapy - emotion regulation skills trainingArm 1. Dialectical behavior therapy - emotion regulation skills training follows the emotion regulation skills DBT Skills Training Manual Second Edition and the DBT Skills Training Handouts and Worksheets Second Edition. This group involves 6 weekly sessions. Arm 2. Dialectical behavior therapy - interpersonal effectiveness skills training follows the interpersonal effectiveness skills DBT Skills Training Manual Second Edition and the DBT Skills Training Handouts and Worksheets Second Edition. This group involves 6 weekly sessions. | Behavioural | Dialectical behavior therapy - emotion regulation skills training |
| Dialectical behavior therapy - interpersonal effectiveness skills trainingArm 2. Dialectical behavior therapy - interpersonal effectiveness skills training follows the interpersonal effectiveness skills DBT Skills Training Manual Second Edition and the DBT Skills Training Handouts and Worksheets Second Edition. This group involves 6 weekly sessions. | Behavioural | Dialectical behavior therapy - interpersonal effectiveness skills training |
| Interpersonal psychotherapyArm 3. Non-skills-oriented interpersonal psychotherapy group follows evidence-based principles on common factors in a group therapy context. This group involves 6 weekly sessions. | Behavioural | Non-skills-oriented interpersonal psychotherapy group |
Primary outcome
Change in Emotional Functioning - Linear
Time frame: Pre-treatment, mid-treatment week 3-4, post-treatment week 6-7, follow-up week 13-14
Assessed with the Difficulties in Emotion Regulation Scale (DERS), which has total scores that range from 36-180, with higher scores indicating more difficulties. Outcomes are reported as slopes (scores over weeks, centered around the start of treatment, with standard errors) per condition, extracted from mixed effects/multilevel models. This measure is listed separately to permit presentation of two units of measure (that are in the same model) - the Linear unit of measure (DERS scores/week), and the Quadratic unit of measure (DERS scores/week^2). This measure reflects the Linear measure.
Change in Borderline Personality Disorder Features - Linear
Time frame: Pre-treatment, mid-treatment week 3-4, post-treatment week 6-7, follow-up week 13-14
Assessed with the abbreviated Borderline Symptom List (BSL23), which has mean scores that range from 0-4, with higher scores indicating more symptoms. Outcomes are reported as slopes (scores rescaled *100 over weeks, centered around the start of treatment, with standard errors) per condition, extracted from mixed effects/multilevel models. This measure is listed separately to permit presentation of two units of measure (that are in the same model) - the Linear unit of measure (BSL scores/week), and the Quadratic unit of measure (BSL scores/week^2). This measure reflects the Linear measure.
Change in Emotional Functioning - Quad
Time frame: Pre-treatment, mid-treatment week 3-4, post-treatment week 6-7, follow-up week 13-14
Assessed with the Difficulties in Emotion Regulation Scale (DERS), which has total scores that range from 36-180, with higher scores indicating more difficulties. Outcomes are reported as slopes (scores over weeks, centered around the start of treatment, with standard errors) per condition, extracted from mixed effects/multilevel models. This measure is listed separately to permit presentation of two units of measure (that are in the same model) - the Linear unit of measure (DERS scores/week), and the Quadratic unit of measure (DERS scores/week^2). This measure reflects the Quadratic measure.
Change in Borderline Personality Disorder Features - Quad
Time frame: Pre-treatment, mid-treatment week 3-4, post-treatment week 6-7, follow-up week 13-14
Assessed with the abbreviated Borderline Symptom List (BSL23), which has mean scores that range from 0-4, with higher scores indicating more symptoms. Outcomes are reported as slopes (scores rescaled *100 over weeks, centered around the start of treatment, with standard errors) per condition, extracted from mixed effects/multilevel models. This measure is listed separately to permit presentation of two units of measure (that are in the same model) - the Linear unit of measure (BSL scores/week), and the Quadratic unit of measure (BSL scores/week^2). This measure reflects the Quadratic measure.
6 secondary outcomes
Change in Self-reported Emotional Reactivity
Time frame: Pre-treatment, mid-treatment week 3-4, post-treatment week 6-7
Change in Self-reported Emotional Regulation
Time frame: Pre-treatment, mid-treatment week 3-4, post-treatment week 6-7
Change in Affect-modulated Startle
Time frame: Pre-treatment, mid-treatment week 3-4, post-treatment week 6-7
Change in Emotional Habituation
Time frame: Pre-treatment, mid-treatment week 3-4, post-treatment week 6-7
Change in Physiological Emotional Reactivity
Time frame: Pre-treatment, mid-treatment week 3-4, post-treatment week 6-7
Change in Deliberate Physiological Emotional Regulation
Time frame: Pre-treatment, mid-treatment week 3-4, post-treatment week 6-7
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Data will be shared via NDA.
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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.
Katherine L Dixon-Gordon, PhD principal investigator
University of Massachusetts, Amherst
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dialectical behavior therapy - emotion regulation skills training, Dialectical behavior therapy - interpersonal effectiveness skills training and Interpersonal psychotherapy in people with Borderline Personality Disorder, run by University of Massachusetts, Amherst at 1 site in United States.
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 5 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 27 Nov 2024. 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 United States. 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. 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?
Yes. Results are posted in the registry (first posted 27 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Emotional Functioning - Linear (time frame: Pre-treatment, mid-treatment week 3-4, post-treatment week 6-7, follow-up week 13-14). The study lists 4 primary outcomes in all. 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 27 Nov 2024.