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.
Study Type
OBSERVATIONAL
Enrollment
28
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.
Adams Clinical
Watertown, Massachusetts, United States
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.
Total scores on the AAPI-CR range from 11 to 275, with higher scores indicating higher levels of agitation and aggression.
Time frame: 90 days
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.
Total scores on the BPDCL range from 47 to 235, with higher scores indicating greater symptom severity.
Time frame: 90 days
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
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.
Total scores on the ZAN-BPD range from 0 to 36, with higher scores indicating greater symptom severity.
Time frame: 90 days
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
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
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The proportion of participants who fail to reach response to a brief course of monthly supportive psychotherapy treatment after 3 months.
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.
Time frame: 90 days
The proportion of participants who fail to reach response to longer term monthly supportive psychotherapy treatment after 8 months.
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.
Time frame: Up to 52 weeks
The proportion of participants who show a partial response to monthly brief or longer term supportive psychotherapy treatment.
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.
Time frame: Up to 52 weeks
The proportion of participants who show a clinically significant response to brief monthly supportive psychotherapy treatment.
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.
Time frame: 90 days
The proportion of participants who show a clinically significant response to longer term monthly supportive psychotherapy treatment.
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.
Time frame: Up to 52 weeks