Methylation Status of BDNF Gene After Dialectical Behavior Therapy in BPD

NCT02134223 | Completed DMC

• 3 other identifiers: 13MMHIS257MMH103-80MOST 103-2314-B-195-002-MY2
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Borderline Personality Disorder

Outcome Measures

Primary Outcomes (1)

• Borderline Symptom Checklist (BSL-23)

  To measure whether there were changes in scores of each symptoms regarding borderline personality disorder, such as number of times of attempting suicide, number of times of attempting self-harm, number of times of feeling emptiness, number of times of dissociations, number of times of risk-taking behaviors, number of times of substance or alcohol misuse etc.

  Changes in scores of BSL-23 before treatment, and at 4, 8, 12 months after starting the treatment

Secondary Outcomes (1)

• The Patient Health Questionnaire (PHQ-9)

  Changes in scores of PHQ-9 before and at 4, 8, 12 months after starting the treatment

Other Outcomes (1)

• Symptom Checklist-90-Revised (SCL-90-R)

  Changes in scores before and at 4, 8, 12 months after starting the treatment

Study Arms (3)

dialectical behavior therapy

EXPERIMENTAL

Primary intervention group: receiving one year of dialectical behavior therapy

Behavioral: Dialectical behavior therapy

treatment as usual

PLACEBO COMPARATOR

Comparison group: receiving one year of treatment as usual

Other: Treatment as Usual: any other drug or psychotherapy offered to participants, except DBT

Receiving no treatment at all

NO INTERVENTION

Healthy control group

Interventions

Dialectical behavior therapy BEHAVIORAL

in standard DBT, we will employ all treatment modalities: a weekly individual (1 hour) and group (2 hours) session, available telephone consultation, and DBT consultation team. DBT participants will be assigned to the next available individual therapist and relevant skills training group. Groups have a minimum of four members before commencement and a maximum of twelve members. Entry to the skills group occurs only at the commencement of the next skills module.

dialectical behavior therapy

Treatment as Usual: any other drug or psychotherapy offered to participants, except DBT OTHER

treatment as usual

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• patients meeting DSM-IV criteria for borderline personality disorder,
• years of age
• have had at least two episodes of suicidal or non-suicidal self-injurious episodes in the past 5 years
• at least one of which is in the 3 months preceding enrollment
• agreement to participate in evaluation of the program

You may not qualify if:

• having a DSM-IV diagnosis of a psychotic disorder, bipolar I disorder, delirium, dementia, mental retardation, or a diagnosis of substance dependence in the preceding 30 days
• living outside of Taipei area
• having any serious medical condition likely to require hospitalization within the next year (e.g. cancer)
• having plans to leave the Taipei area in the next 1 year

Sponsors & Collaborators

• Mackay Memorial Hospital: lead
• Ministry of Science and Technology, Taiwan: collaborator

Study Sites (1)

Mackay Memorial Hospital

Taipei, 251, Taiwan

Location

Related Publications (1)

• Storebo OJ, Stoffers-Winterling JM, Vollm BA, Kongerslev MT, Mattivi JT, Jorgensen MS, Faltinsen E, Todorovac A, Sales CP, Callesen HE, Lieb K, Simonsen E. Psychological therapies for people with borderline personality disorder. Cochrane Database Syst Rev. 2020 May 4;5(5):CD012955. doi: 10.1002/14651858.CD012955.pub2.

  PMID: 32368793 DERIVED

MeSH Terms

Conditions

Borderline Personality Disorder

Interventions

Dialectical Behavior Therapy; Therapeutics

Condition Hierarchy (Ancestors)

Personality Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Shu-I Wu, MD, PhD

  Mackay Memorial Hospital, Taipei, Taiwan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2014
• First Posted: May 9, 2014
• Study Start: March 20, 2014
• Primary Completion: January 25, 2017
• Study Completion: February 26, 2020
• Last Updated: September 5, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)