Effectiveness of a Short and Telematic Version of Cognitive-behavioral Treatment for Borderline Personality Disorder: an Open-label, Non-inferiority Randomized Clinical
试验速览
- 阶段
- 不适用
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Change in the intensity and frequency of suicidal and self-harming activity, measured by a Spanish version of the Suicide Attempt Self-Injury Interview (SASII)
研究概览
简要总结
Standard Dialectical Behavioral Therapy (DBT)is an effective treatment for Borderline Personality Disorder (BPD), particularly for patients with significant behavioral and affective dysregulation, including suicidality. However, DBT in its original format is delivered in 12 months, and even though currently there are shorter versions of the treatment being developed and tested, in the context of public mental health care in Chile a shorter, intensive and lighter version of the treatment is likely needed to help patients seeking help for BPD symptoms. This study will test whether a 3 month, intensive and simplified version of DBT is at least equivalent to standard six months DBT with all its components (skills training, individual therapy, coaching calls, and treatment-team consulting). 120 patients diagnosed with BPD we'll be randomly assigned to receive either the short, intensive 3-month intervention or the longer standard 6-month DBT intervention. Baseline measures will be taken pre-treatment, upon treatment completion, and at a 4-month follow-up. Session-to-session change in BPD symptoms will also be measured throughout the treatments. Primary outcomes for the study are BPD symptoms, frequency, and intensity of suicidal activity. Secondary outcome measures include depression scores, quality of life, and ER visits, and days in inpatient care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Outcome assessors will not be therapists in the study and will be blind to treatment allocation. The only exception involves assessors in charge of evaluating care usage (e.g. ER visits and inpatient) as they will probably find out the treatment condition. These assessors will not participate in the assessment of primary or other secondary outcome measures.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •BPD diagnosis according to DSM-IV criteria, evaluated through a SCID-II structured interview.
- •History of suicide attempt or self-harm operationalized as at least two episodes of suicide or self-harm in the last 24 months
- •Provide signed informed consent to participate in the study.
- •Participant has not received more than 8 weeks of DBT in the past 24 months.
排除标准
- •Fulfill diagnostic criteria for psychotic disorders classified in ICD-10 (F20-F29), evaluated through the MINI interview.
- •Diagnosis of Antisocial Personality Disorder evaluated through the SCID-II.
- •Active substance use disorder within the last 3 months, assessed by ASSIST.
- •Harmful use or problem dependence on alcohol assessed through AUDIT.
- •Meet criteria for Bipolar Affective Disorder type I assessed through the MINI Mania module.
- •Significant cognitive impairment assessed through Moca (Moca> 21).
- •Diagnosis recorded in the clinical record of intellectual-cognitive disability.
- •Recording in the clinical record of medical or surgical problems that could imply a probable hospitalization within one year of the start of the study (for example, cancer, coronary heart disease, etc.).
研究组 & 干预措施
b-DBT (Brief Dialectical Behavioral Therapy)
3 months of and intensive modified DBT intervention.
干预措施: Dialectical Behavior Therapy -3-months (Behavioral)
s-DBT (standard Brief Dialectical Behavioral Therapy)
6 months of a standard DBT intervention (this is a shorter version of the original 12-month DBT, but includes all four active components delivered over 6 months)
干预措施: Dialectical Behavior Therapy -6-months (Behavioral)
结局指标
主要结局
Change in the intensity and frequency of suicidal and self-harming activity, measured by a Spanish version of the Suicide Attempt Self-Injury Interview (SASII)
时间窗: Administered pre-treatment and then at treatment completion, which is at the 3 month mark or 6 month mark depending on thr study arm. Follow-up assessment at month 7 or month 10 depending on study arm.
Assessment recovers detailed information about frequency, topography, severity, social context, intent, precipitating events, concurrent events and outcomes of suicidal and self-harming behavior during a three-month period.
Change in Borderline Personality Disorder Symptoms as measured by the Zanarini Rating Scale for Borderline Personality Disorder - ZAN-BPD
时间窗: Administered pre-treatment and then weekly until 3 months or 6 months depending on thr study arm. Follow-up assessment at month 7 or month 10 depending on study arm.
We will capture incremental change in affect dysregulation, behavioral dysregulation, interpersonal functioning, and cognitive/self functioning
次要结局
- Reasons for Living measured though the RFL(Administered pre-treatment and then at treatment completion, which is at the 3 month mark or 6 month mark depending on thr study arm. Follow-up assessment at month 7 or month 10 depending on study arm.)
- Depression Symptomatology measured through the Patient Health Questionnaire - PHQ-9(Administered pre-treatment and then at treatment completion, which is at the 3 month mark or 6 month mark depending on thr study arm. Follow-up assessment at month 7 or month 10 depending on study arm.)
- Quality of life measured through the World Health Organization Quality of Life brief version; WHOQOL-BREF(Administered pre-treatment and then at treatment completion, which is at the 3 month mark or 6 month mark depending on thr study arm. Follow-up assessment at month 7 or month 10 depending on study arm.)
- Psychiatric inpatient days measured by the integrated electronic records.(Administered pre-treatment and then at treatment completion, which is at the 3 month mark or 6 month mark depending on thr study arm. Follow-up assessment at month 7 or month 10 depending on study arm.)
- Emergency Room Visit measured by the integrated electronic records.(Administered pre-treatment and then at treatment completion, which is at the 3 month mark or 6 month mark depending on thr study arm. Follow-up assessment at month 7 or month 10 depending on study arm.)