Effects of Emotion-focused vs. Cognitive Schema Therapy Interventions on Emotion Regulation Deficits in Borderline Personality Disorder - Associations Between Clinical Efficacy, Brain Network Function and Local Glutamate/GABA Metabolism
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Changes in emotion regulation capabilities
研究概览
简要总结
Background: The major aim of this study is to compare the effects of emotion focused (experiential) and cognitive interventions of schema therapy (ST) on emotion regulation deficits in patients with borderline personality disorder (BPD) according to DSM-V (alternative model) criteria. In a randomized, single-blinded parallel-group design clinical effects as well as effects on neurotransmitter metabolism and connectivity will be compared.
Method: While the 9-weeks treatment protocol of particular interest includes emotion focused interventions (ST-EF, n=60) such as chair dialogs, imagery rescripting or role play, the active control condition (ST-AC, n=60) is restricted to cognitive interventions, e.g. psychoeducation or pro/contra discussions. MEGA-PRESS 1H-MR spectroscopy and resting-state functional MR imaging (rs-fMRI) will be used before/after treatment protocols (T0-T1) and 6 months after the end of therapy (T2) to assess the effects on glutamate (Glx) and GABA metabolism in key regions of the target networks (executive control network, ECN: dorsolateral prefrontal cortex, DLPFC; salience network, SN: anteromedial cingulate cortex, aMCC; default mode network, DMN: pregenual cingulate cortex, pgACC) and to investigate the corresponding altered connectivity in these networks. The biological aberrations at T0 as compared to healthy controls (n=60) and treatment effects (at T1 and T2, n≥40 in each condition) on these aberrations will be linked to clinical effects measured by an extensive test battery with particular interest on emotion regulation, and specified by the Reliable Change Index (RCI). For longitudinal data mixed model analysis will be performed.
The main questions are (1) whether the emotion regulation deficit and the pattern of BPD-specific symptomatology are associated with a specific pattern of Glx and GABA concentrations in the DLPFC, aMCC and pgACC and corresponding deviations of functional connectivity within the ECN, SN and DMN. Hypothesis: Depending on primary and secondary outcome measures at T0, altered RSFC in the DMN, SN and ECN and corresponding altered Glx or GABA concentrations are assumed. (2) whether both treatment conditions have different clinical effects on the ability to regulate emotions and whether the respective clinical effects are associated with the changes in neurobiological aberrations. Hypothesis: It is hypothesized that the ST-EF condition will improve emotion regulation skills more effectively than the control condition. Only in the ST-EF condition are higher response and remission rates expected in the primary and secondary outcome measures, as well as effects on the ECN, SN and DMN with corresponding changes in RSFC and Glx or GABA concentrations.
详细描述
2.3 Work program and proposed research methods
The work program is divided into the following three work packages:
- Recruitment of patients and healthy subjects including diagnostic and psychological assessments as well as assessment of clinical outcome.
- Collecting the MR-related (Glx, GABA, RSFC).
- Data evaluation and analysis of the results.
Recruitment of patients and healthy subjects Patients will be recruited from routine admissions to the psychiatric day-hospital. According to our power calculation, we aim to include at least 120 patients with BPD according to the general and borderline specific criteria of the alternative DSM-5 Model for Personality Disorders (Section III of DSM 5, p 761ff (APA, 2013), which includes a specific dimensional pattern of impairments in personality functioning and pathological personality traits for diagnosis.
A total of at least 60 healthy volunteers will be recruited by newspaper advertisement. They will be examined using a semi-structured interview and self-ratings (SCL-90-R) to assess current mental status, to exclude personal or first-degree family history of psychiatric disorders (including substance abuse) or history of neurological or major medical conditions that might affect brain function.
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 (Participant, Outcomes Assessor)
盲法说明
Parallel-group: Both conditions (emotion focussed, ST-EF and active control, ST-AC) are highly standardized and active in terms of their expected clinical effect, which was a precondition for a positive ethics approval.
Randomized: Patients are randomly assigned to the ST-EF or ST-AC condition according to a randomization list established by an independent statistician, and applied to incoming help-seeking patients by an independent admission management (managing nurse, not a member of the research team).
Single-blinded: Researchers are blind as regards group belonging of participants.
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients are eligible if they
- •fulfil diagnostic criteria (1.-
- •see below) of BPD according to the Alternative DSM-5 Model (Sec-tion III of DSM 5, p 761ff (APA, 2013),
- •are between 18 and 30 years of age,
- •are female,
- •are right-handed,
- •are free of any treatment with antidepressants, antipsychotic or mood stabilizing medication (sporadic use of tranquillizers to induce sleep will be permitted)
- •have never been in psychotherapy before (in particular DBT, ST, CBT, TBP),
- •are willing to participate in (group) therapy,
- •are willing to participate in the study
排除标准
- •Patients will be excluded if they
- •acutely suffer suicidal ideas,
- •suffer manifest affective or anxiety disorder ac-cording to DSM-5 criteria or have a lifetime his-tory of or current psychotic disorder (except brief psychotic disorder according to the DSM-5),
- •present a clinically manifest trauma-related dis-order (in particular PTSD),
- •suffer dissociative identity disorder, substance dependence needing clinical detoxification, ano-rexia nervosa with BMI < 14 or a serious and/or unstable medical illness,
- •have an IQ below 80,
- •are at any risk in terms of MRI investigations
结局指标
主要结局
Changes in emotion regulation capabilities
时间窗: 9 weeks (T1), 6 month after end of therapy (T2)
Being the core issue of this study, changes in emotion regulation capabilities are defined as primary outcome and will be assessed by the Emotion Regulation Inventory (ERI), which follows the Process Model of Emotion Regulation proposed by James Gross. Evaluation of changes in primary and secondary criteria and their clinical significance: In each therapeutic condition the improvement of each patient in measures of the primary and secondary outcome criteria will be estimated by the Reliable Change Index (RCI)(1)((2), which summarizes changes at the level of an individual in the context of observed changes for the whole sample. More detailed information on RCI scores and their meaning in each outcome measurement is given in the uploaded material.
次要结局
- Improvement of BPD specific symptomatology(9 weeks (T1), 6 month after end of therapy (T2))
- Changes of the intensity of early maladaptive schemas.(9 weeks (T1), 6 month after end of therapy (T2))
- Changes of the intensity of schema modes.(9 weeks (T1), 6 month after end of therapy (T2))
- Change of personality traits(9 weeks (T1), 6 month after end of therapy (T2))
研究者
Stefan Smesny
Prof. Dr. S. Smesny (MD, PhD)
Jena University Hospital