Status
Conditions
Treatments
Study type
Funder types
Identifiers
About
Borderline personality disorder (BPD) is a chronic and debilitating syndrome associated with considerable morbidity, mortality, and high rates of medical and psychiatric utilization services. Research focusing on finding a biological observable marker for the purpose of monitoring treatment effects has started to draw attention. Recent research has implicated that brain-derived neutrophilic factor (BDNF) might be a natural candidate for a biological correlate of early life stress. The alterations in levels of BDNF or BDNF methylation in BPD patients compared to general population, or pre- and post- psychotherapeutic treatment might indicate the consequence of epigenetic modification associated with stressful experience or suicide, and may later be able to explain the psychopathology or neuro-development of BPD.
Method: The investigators therefore propose this current randomized control trial to test whether epigenetic changes happen during and after DBT treatments, and not TAU. Proportions having suicide or non-suicidal self injurious behaviors will be followed and tested against changes in BDNF methylation levels. Other clinical symptoms will as be assessed, including suicidality, depression, hopelessness, quality of life, disability, service utilization, and function.
In the first to third years of this study, the investigators will aim to recruit 180 study and control subjects, to gather information, to collect biological samples, to give out one-year of psychotherapy per subject, to evaluate results before, during, and after treatment. In addition, the investigators also hope to explore the effects of known or unknown drugs associated with the change of DNA methylation at cell level.
Hypothesis:
Responders of participants who receive DBT will show greater decrease in BDNF methylation levels than patients receiving TAU.
Full description
Background: Borderline personality disorder (BPD) is a chronic and debilitating syndrome associated with considerable morbidity, mortality, and high rates of medical and psychiatric utilization services. The prevalence of BPD is around 1%-2% in general population. However, suicidality and self-injury are common, an estimated 69-80% of patients with BPD attempt suicide and a higher percentage engage in nonsuicidal self-injurious behavior. The rate of completed suicide in this group is appropriately 10%. Several Western literature have demonstrated the therapeutic effects of dialectical behavior therapy (DBT) in patients with BPD. However, research focusing on finding a biological observable marker for the purpose of monitoring treatment effects has started to draw attention. Recent research has implicated that brain-derived neutrophilic factor (BDNF) might be a natural candidate for a biological correlate of early life stress. The alterations in levels of BDNF or BDNF methylation in BPD patients compared to general population, or pre- and post- psychotherapeutic treatment might indicate the consequence of epigenetic modification associated with stressful experience or suicide, and may later be able to explain the psychopathology or neurodevelopment of BPD.
Such studies investigating associations of changes in methylation levels, with changes in depressive scores, hopelessness scores, impulsivity, or effects of psychotherapy have never been done in Asian countries. Little is known about the possible epigenetic changes related to Western psychological therapies for BPD patients in Asia.
Method: The investigators therefore propose this current randomized control trial to test whether epigenetic changes happen during and after DBT treatments, and not treatment as usual (TAU). Proportions having suicide or non-suicidal self injurious behaviors will be followed and tested against changes in BDNF methylation levels. Other clinical symptoms will as be assessed, including suicidality, depression, hopelessness, quality of life, disability, service utilization, and function. Inclusion criteria will be subjects who fulfill the Diagnostic Statistic Manual-IV (DSM-IV) criteria for BPD, 20-60 years of age, sign the informed consent, have had at least two episodes of suicidal or non-suicidal self-injurious episodes in the past 5 years, and at least one of which is in the 3 months preceding enrollment. The exclusion criteria include psychotic disorder, bipolar I disorder, severe physical illness, and mental retardation. Outcome measures and blood samples will be obtained at pre-treatment, 4-month, 8-month and post-treatment (12-month) during 1-year protocol. Using semi-structured interview and a battery of self-report forms, a range of symptoms and behaviors associated with BPD will be assessed. Outcome variables will be evaluated by blinded assessors.
In the first to third years of this study, the investigators will aim to recruit 180 study and control subjects, to gather information, to collect biological samples, to give out one-year of psychotherapy per subject, to evaluate results before, during, and after treatment. The TAU group would receive any therapy the patient could get excluding DBT. In addition, we also hope to explore the effects of known or unknown drugs associated with this project (such as decitabine, azacitidine, trichostatin A, valproic acid) on the change of DNA methylation at cell level. As a consequence, considering potential developments of biological correlates or medications as future evidences of treatments for BPD, this research is expected to take at least three years of investment.
Primary hypothesis:
Responders of participants who receive DBT will show greater decrease in BDNF methylation levels than patients receiving TAU.
Secondary Hypotheses:
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
60 participants in 3 patient groups, including a placebo group
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal