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Completed

NCT Number: NCT05025670

Tracking Response in Advance of Investigational Trials, Borderline Study

TRAIT-BOR is an open-label psychotherapy treatment study for adults who meet the diagnostic criteria for Borderline Personality Disorder (BPD) and are seeking enrollment in a clinical trial of a novel compound to treat BPD. The current study seeks to determine if there are therapeutic benefits to more infrequent, short term, or longer term supportive psychotherapy.

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Key information

Conditions

Borderline Personality Disorder Mental Disorders Personality Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Adams Clinical

Watertown, Massachusetts, 02472, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Participant has signed an ICF prior to any study-specific procedures being performed.
  • Participant has a diagnosis of Borderline Personality Disorder, per DSM-5 criteria, as confirmed on the MINI, and ≥ 16 AAPI-CR total score.
  • Participant is in good physical health, and, in the opinion of the investigator, is a suitable candidate for treatment with monthly supportive psychotherapy.
  • Participant is 18 to 65 years old.
  • For participants already receiving psychotherapy, including Dialectical Behavioral Therapy (DBT), they must continue their regular course of treatment for the duration of the current study.

Exclusion criteria

  • Participant is pregnant, breast-feeding, or planning to become pregnant.
  • A history or presence of a clinically significant hepatic, renal, gastrointestinal, cardiovascular, endocrine, respiratory, immunologic, hematologic, dermatologic, or neurologic abnormality, which in the opinion of the investigator may impact participant safety or study results.
  • Participant has a history of any psychiatric condition other than BPD, which in the opinion of the investigator is primary, or any other psychiatric or neurologic disorder or symptom that could pose undue risk to the participant or compromise the study.
  • Any participant who represents an acute suicidal risk in the opinion of the investigator, as defined by a "yes" response to suicidal ideation on questions 4 or 5, or answer "yes" to suicidal behavior questions on the CSSR-S within 90 days of screening.
  • Any participant who represents an acute homicidal risk in the opinion of the investigator.
  • Moderate or severe substance use disorder within 90 days prior to screen, according to DSM-5 criteria that in the opinion of the investigator could pose undue risk to the participant, or compromise the study.
  • Any condition that, in the opinion of the investigator, makes the participant unsuitable for the study.
  • Participants who require ongoing treatment with typical antipsychotics.

Treatment and study plan

supportive psychotherapy

Behavioral

Participants will receive monthly 30-45 minute supportive psychotherapy sessions. Supportive psychotherapy is an integrative and eclectic psychotherapeutic approach, based upon the individual's needs and symptoms. It draws from elements of a variety of psychotherapeutic disciplines, including cognitive-behavior, psychodynamic, and interpersonal therapies.

Primary outcomes

  1. Stability of symptoms and treatment response as defined as change in total scores on the Agitation-Aggression Psychiatric Inventory - Clinician Report (AAPI-CR) from Baseline/Day 0 to End of Cycle (EOC)/Day 90.

    Time frame: 90 days

    Total scores on the AAPI-CR range from 11 to 275, with higher scores indicating higher levels of agitation and aggression.

  2. Stability of symptoms and treatment response as defined as change in total scores on the self-report Borderline Personality Disorder Checklist (BPDCL) from Baseline/Day 0 to End of Cycle (EOC)/Day 90.

    Time frame: 90 days

    Total scores on the BPDCL range from 47 to 235, with higher scores indicating greater symptom severity.

  3. The proportion of participants who have clinically significant agitation and aggression symptoms, as defined as AAPI-CR Agitation and Aggression (A/A) subscale score ≥ 16 and sum of the A/A subscale severity scores ≥ 6.

    Time frame: Up to 52 weeks

Secondary outcomes

  1. Stability of symptoms and treatment response as defined as change in total score on the Zanarini Rating Scale for Borderline Personality Disorder (ZAN-BPD) from Baseline/Day 0 to End of Cycle (EOC)/Day 90.

    Time frame: 90 days

    Total scores on the ZAN-BPD range from 0 to 36, with higher scores indicating greater symptom severity.

  2. Stability of symptoms and treatment response as defined as change in total scores on the AAPI-CR from Baseline/Day 0 to End of Study (EOS)/Day 224.

    Time frame: Up to 52 weeks

  3. Stability of symptoms and treatment response as defined as change in total scores on the BPDCL from Baseline/Day 0 to End of Study (EOS)/Day 224.

    Time frame: Up to 52 weeks

  4. The proportion of participants who fail to reach response to a brief course of monthly supportive psychotherapy treatment after 3 months.

    Time frame: 90 days

    Defined as either AAPI-CR Total score ≥ 16 by EOC/Day 90 or < 25% decrease in AAPI-CR Total Score from Baseline/Day 0 to EOC/Day 90 and verified by clinician-rated assessment as indicated by a CGI ≥ 4 at EOC/Day 90.

  5. The proportion of participants who fail to reach response to longer term monthly supportive psychotherapy treatment after 8 months.

    Time frame: Up to 52 weeks

    Defined as either AAPI-CR Total score ≥ 16 by EOS/Day 224 or < 25% decrease in AAPI-CR Total Score from Baseline/Day 0 to EOS/Day 224 and verified by clinician-rated assessment as indicated by a CGI ≥ 4 at EOS/Day 224.

  6. The proportion of participants who show a partial response to monthly brief or longer term supportive psychotherapy treatment.

    Time frame: Up to 52 weeks

    Defined as ≥ 25% to < 50% reduction in AAPI-CR Total Score from Baseline/Day 0 to EOC/Day 90 and ≥ 25% to < 50% reduction in AAPI-CR Total Score from Baseline/Day 0 to EOS/Day 224.

  7. The proportion of participants who show a clinically significant response to brief monthly supportive psychotherapy treatment.

    Time frame: 90 days

    Defined as ≥ 50% reduction in AAPI-CR Total Score from Baseline/Day 0 to EOC/Day 90 and verified by clinician-rated assessment as indicated by a CGI ≤ 3 at EOC/Day 90.

  8. The proportion of participants who show a clinically significant response to longer term monthly supportive psychotherapy treatment.

    Time frame: Up to 52 weeks

    Defined as ≥ 50% reduction in AAPI-CR Total Score from Baseline/Day 0 to EOS/Day 224 and verified by clinician-rated assessment as indicated by a CGI ≤ 3 at EOS/Day 224.

Other outcomes

  1. The initial prevalence of comorbid psychiatric symptoms as assessed by the Mini-International Neuropsychiatric Inventory (MINI).

    Time frame: Up to 52 weeks

  2. The proportion of participants who elect to add psychopharmacologic treatment to their monthly supportive psychotherapy by enrolling in an industry-sponsored clinical trial for BPD at the site.

    Time frame: Up to 52 weeks

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Adams Clinical

Network

Registry information

Acronym: TRAIT-BOR

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Aug 27, 2021
Registry last updated
Mar 27, 2023

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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