The Influence of Treatment Format on Effectiveness of and Dropout From Schema Therapy for Borderline Personality Disorder: Individual vs. Combined Individual Group Schema Therapy
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 132
- 试验地点
- 5
- 主要终点
- Borderline Personality Disorder Severity
研究概览
简要总结
The goal of this clinical trial is to compare etc. in patients with borderline personality disorder pure individual schema therapy to combined individual-group schema therapy. The main questions it aims to answer are:
- is there a difference in effectiveness?
- is there a difference in (early) treatment dropout?
Participants will receive either
- individual schema therapy or
- combined individual-group schema therapy.
Researchers will compare individual to combined individual-group schema therapy see if there is a difference in effects and/or a difference in dropout from treatment.
详细描述
Schema Therapy (ST) for Borderline Personality Disorder (BPD) was originally developed and tested as an individual treatment. Since 2009 group-ST became popular as an supposedly efficient alternative. A RCT found combined individual-group ST to be superior to predominantly group-ST. Thus, individual ST is important. The question arises how combined individual-group ST compares to purely individual ST. This study compares the two formats of ST in a multicenter randomized clinical trial (RCT). The primary outcomes are severity of BPD and (early) treatment dropout. Secondary outcomes include: measures of specific BPD-symptoms; schemas and schema-modes; general mental symptoms; general functioning; and happiness. Moderators hypothesized to predict what patient characteristics are related to differences in effectiveness between the 2 formats are also tested. At least 132 BPD patients from at least 2 sites will be randomized to combined individual-group ST or individual ST. Treatments will take 2 years. Assessments take place every 6 months, and 1 year after end of treatment.
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
- Double (Investigator, Outcomes Assessor)
盲法说明
Assessors and investigator are blind to treatment arm up to and including the last follow-up assessment.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •BPD as defined by the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5), assessed with the Structured Clinical Interview for the DSM-5 Personality Disorders (SCID-5-PD), as primary diagnosis
- •BPDSI total score ≥ 20 (i.e, severity in the BPD range, Giesen-Bloo et al., 2010)
- •Ability to understand, read, write and speak Dutch, or English if the site has research assistants and therapists of both conditions that are sufficiently fluent in English, as well as an English ST group (as at ACTP).
排除标准
- •DSM-5 substance use disorder that needs clinical detox according to the clinical staff (after 6 weeks of abstinence participation is possible).
- •Comorbid psychotic disorder (patients with temporary psychotic problems falling under BPD criterion 9 are not excluded)
- •DSM-5 Bipolar disorder, type 1 (current or past)
- •Acute suicide risk
- •Intelligence Quotient (IQ) < 80
- •Serious neurological problems such as dementia
- •Patients should not start with any form of psychological treatment during screening or during the study's waitlist or treatment. (Low frequency supportive treatment may be continued during wait and screening, but not during the study treatment.)
- •Not able or willing to plan participation in the treatment sessions. Note
- •In case of suspicion of exclusion criteria that need specific assessment, like IQ and dementia, a formal diagnostic assessment needs to be done before in/exclusion can be decided.
- •No other psychological treatment during the study follow-up period is provided, unless this is necessary (clinical judgment). The 1 year treatment-free follow-up period is part of the treatment protocol, to help patients gain experience with life without mental health care. After 1 year further treatment can be offered, if indicated.
研究组 & 干预措施
Individual Schema Therapy (IST)
IST will follow the revised protocol described by Arntz & van Genderen. In the first year, 2 sessions (of 50-60 minutes each) per week will be provided, with at least one day in between. In the second year, the frequency will be reduced to once a week for the first 6 months, for the next 3 months to once every two weeks, and for the last 3 months three (booster) sessions will be offered. Therapists need to be trained at least at the junior level of the Dutch ST Association, or of the International ST society (ISST), or having successfully completed the basic IST training and delivering the trial treatments under supervision of a recognized ST supervisor.
干预措施: Individual Schema Therapy (IST) (Behavioral)
Combined Individual-Group Schema Therapy (IGST)
In IGST individual sessions (45-60 min) are provided weekly in the first year, and once every 2 weeks in the first three quarters of the second year, after which 3 monthly booster sessions are offered. Group sessions take place once per week for 1.5 years. After 1.5 years, patients leave the group but continue with IST during the last .5 year. If slots are available, new patients can enter the ST group every 10 weeks.
GST is provided as semi-closed group format developed from the closed format as developed by Farrell & Shaw. IST is based on Arntz & van Genderen, with the addition that IST and GST are coordinated at weekly peer supervision meetings, and that problems related to the patient's participation in the group are put on the IST agenda.
GST therapists don't need to be IST therapist of their patients. The same training requirements hold as in the IST arm. Additionally, GST-therapists completed GST training and receive(d) at least 10 GST supervisions.
干预措施: Individual-Group Schema Therapy (IGST) (Behavioral)
结局指标
主要结局
Borderline Personality Disorder Severity
时间窗: 0, 6,12,18, 24 and 36 months
The severity of manifestations of Borderline Personality Disorder during the last 3 months, assessed with a semi-structured clinical interview, the Borderline Personality Disorder Severity Index 5 (BPDSI-5), by an independent trained rater, blind for treatment arm. Minimum score is 0; maximum is 90; higher scores mean worse outcome.
Early treatment dropout rate
时间窗: 6 months
Rate of dropout from treatment within the first 6 months
次要结局
- Suicidality(0, 6,12,18, 24 and 36 months)
- Schema Modes(0, 6,12,18, 24 and 36 months)
- Number of suicide attempts(0, 6,12,18, 24 and 36 months)
- Severity of each of the 9 BPD criteria(0, 6,12,18, 24 and 36 months)
- General, social, and societal functioning(0, 6,12,18, 24 and 36 months)
- Happiness(0, 6,12,18, 24 and 36 months)
- Early Maladaptive Schemas(0, 6,12,18, 24 and 36 months)
- Subjective burden of Borderline Personality Disorder(0, 6,12,18, 24 and 36 months)
- General psychopathology symptoms(0, 6,12,18, 24 and 36 months)
- Number of medications used(0, 6,12,18, 24 and 36 months)
研究者
Arnoud Arntz
Professor
University of Amsterdam