Clinical trial NCT05989529: Delving Into Borderline Personality Disorder Clinical Trial Experiences
Official title: Uncovering Clinical Trial Engagement Among Individuals With Borderline Personality Disorder
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Borderline Personality Disorder
Keywords: borderline personality disorder
Lead sponsor: Power Life Sciences Inc.
Sponsor class: INDUSTRY
First posted: 2023-08-14
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with borderline personality disorder who are actively considering enrolling in an observational clinical trial but have not yet completed enrollment and randomization phases in said clinical trial.

Brief summary: Taking part in medical study usually favors a particular demographic group. But there is limited research available to explain what trial attributes affect the completion of these specific demographic groups.

This study will admit a wide range of data on the clinical research experience of borderline personality disorder patients to determine which factors prevail in limiting a patient's ability to join or finish a trial.

It will also try to analyze data from the perspective of different demographic groups to check for recurring trends which might yield insights for the sake of future borderline personality disorder patients.


Eligibility criteria: Inclusion Criteria:

* Aged ≥ 18 years old
* Clinical diagnosis of Borderline Personality Disorder
* Able to comprehend the investigational nature of the protocol and provide informed consent

Exclusion Criteria:

* No diagnosis of Borderline Personality Disorder confirmed
* Inability to perform regular electronic reporting
* Patient does not understand, sign, and return consent form

Primary outcomes:
measure: Number of patients who decide to enroll in a borderline personality disorder clinical research
timeFrame: 3 months
measure: Rate of patients who remain in borderline personality disorder clinical research to trial completion
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Power Life Sciences
state: California
Study officials:
affiliation: Power Life Sciences Inc.
name: Michael B Gill
role: STUDY_DIRECTOR
References:
citation: Garcia MC. [Treatment of borderline personality disorder with opioid antagonists: buprenorphine, nalmefene, naloxone and naltrexone in the treatment of dissociative symptoms, self-mutilation and suicidal behavior]. Vertex. 2020 Apr;XXX(148):1-10. doi: 10.53680/vertex.v30i148.122. Spanish.
citation: Kvarstein EH, Froyhaug M, Pettersen MS, Carlsen S, Ekberg A, Fjermestad-Noll J, Ulvestad DA, Gikling EL, Hjermann E, Lindberget K, Omvik S, Eikenaes IU, Hummelen B, Morken KTE, Wilberg T, Pedersen GAF. Improvement of personality functioning among people treated within personality disorder mental health services. A longitudinal, observational study. Front Psychiatry. 2023 May 9;14:1163347. doi: 10.3389/fpsyt.2023.1163347. eCollection 2023.
citation: Jacob GA, Hauer A, Kohne S, Assmann N, Schaich A, Schweiger U, Fassbinder E. A Schema Therapy-Based eHealth Program for Patients with Borderline Personality Disorder (priovi): Naturalistic Single-Arm Observational Study. JMIR Ment Health. 2018 Dec 17;5(4):e10983. doi: 10.2196/10983.