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临床试验/NCT04157907
NCT04157907招募中不适用

Reflective Functioning and Psychotherapy Processes in Mentalization Based Therapy

Oslo University Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2019年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
60
试验地点
1
主要终点
Toronto Alexithymia Scale, TAS-20, change during treatment and 3 months follow-up

研究概览

简要总结

Borderline personality disorder (BPD) is a pervasive mental disorder characterized by emotional instability, self-destructive behavior, identity problems and unstable relationships. Persons with this disorder usually experience significant distress in terms of depression, anxieties, suicidal behavior, and difficulties in close relationships as well as with work- and social functioning. Recent research has found the prognosis of BPD to be better than previously assumed, and many patients improve from treatment.

Mentalization based therapy (MBT) is a specialized evidenced based therapy for patients with BPD. Like for other specialized treatments for this disorder, the outcome of therapy is typically variable, some patients respond well to treatment, whereas others respond less. It is therefore important to understand how treatment works in order to improve therapies and tailor treatment to individual patients.

Mentalizing is the ability to understand ourselves and others in terms of mental states, like intentions, feelings, desires, attitudes, and so on, or briefly; the ability to mind own and other's minds. Impaired mentalizing capacity is an assumed core aspect of BPD, underlying many of the symptoms of this disorder. MBT focuses on the patients mentalizing difficulties and is typically offered as a long-term combined treatment program comprising individual and group therapy, as well as psychoeducation. Several studies have documented positive effects of MBT in terms of reduced suicidal behavior, symptoms, interpersonal problems, medication, and health service use. It is assumed that such clinical improvement is made possible by helping the patients to develop their mentalizing abilities.

Yet, no study has investigated whether patients' mentalizing capacity changes during MBT, or to what degree outcome of MBT is mediated by improved mentalizing. Mentalizing is, however, a complex phenomenon and difficult to measure. Research in this area has been hampered by a lack of suitable methods. Mentalizing is usually operationalized as Reflective Functioning (RF) assessed by the RF Scale. The gold standard is to apply the RF Scale on the Adult Attachment Interview. However, this is a time consuming and costly method, and there is a need for testing other methods as well.

The overall aim of the project is to study treatment processes in MBT for patients with BPD. It focuses on patients' mentalizing difficulties before, during and at the end of therapy. Mentalizing is assessed using different methods. Our main research questions are:

  1. To what degree does patients' level of RF change during MBT?
  2. Is there a relationship between RF and outcome of MBT?
  3. What is the relationship between RF and therapy processes in MBT?
  4. Is it possible to identify in-session processes that promote mentalizing?
  5. What is the clinical utility of various methods of RF assessment?

详细描述

BACKGROUND Borderline personality disorder (BPD) BPD is a pervasive mental disorder characterized by emotional instability, self-destructive behavior, identity problems and unstable interpersonal relationships. The disorder is associated with high levels of symptom distress, suicidal behavior, psychosocial impairment, and high rates of comorbid mental disorders such as mood, anxiety, and substance use disorders, as well as significant health service utilization and costs. Recent research has found the prognosis of BPD to be better than previously assumed. Yet, despite high rates of diagnostic remission many patients continue to have poor vocational and social functioning.

Several specialized and evidence based psychotherapies targeting characteristic BPD symptoms have been developed during the past decades, like Dialectical behavioral therapy, Transference focused therapy, Schema focused therapy and Mentalization based therapy. Across specific treatment approaches the outcome of therapy is typically variable, some patients respond well to treatment, whereas others respond less or even deteriorate. It is therefore important to understand how treatment works in order to improve therapies and tailor treatment to individual patients.

Mentalization based therapy (MBT) MBT is a manualized psychodynamic psychotherapy which focuses specifically on the patients' mentalizing difficulties. Mentalization is defined as the capacity to perceive human behavior as expressions of mental states, like thoughts, affects, dreams and intentions, and is usually operationalized as Reflective Functioning (RF) assessed by the RF Scale. Impaired mentalizing capacity is an assumed core aspect of BPD underlying characteristic features such as poor affect regulation, impulse control problems, and incoherent internal representations of self and others leading to unstable relationships and self- esteem. MBT is prototypically a combined treatment program comprising individual and group therapy, as well as psychoeducation. Several studies, including RCTs have documented positive effects of MBT in terms of reduced suicidal behavior, symptoms, interpersonal problems, medication, and health service use. There are also indications that MBT may be particularly helpful for more severely disturbed patients with extensive comorbidity.

Yet, no study has investigated whether patients' mentalizing capacity changes during MBT, or to what degree outcome of MBT is mediated by improved RF. One study found that outcome of two different treatment approaches (not MBT) differentially depended on patients' pretreatment levels of RF, indicating that RF may be a valuable variable for treatment selection and outcome. There are also indications that RF may improve during Transference focused therapy. However, there is a general lack of studies investigating the role of RF in the unfolding of psychotherapy processes and outcome of MBT. Thus, more studies are needed to gain knowledge of mechanisms of change in MBT.

RF and psychotherapy processes Common therapeutic factors are factors that are believed to function across different types of treatment, in contrast to specific factors which are seen as operating as part of specific therapies and interventions. An early good therapeutic alliance between patient and therapist is the most widely recognized common factor in individual therapies. The Working Alliance Inventory is an established method for assessment of therapeutic alliance in individual therapy. As to group therapies alliance to therapists and group members, as well as group cohesion are suggested as important common factors, but the evidence is not consistent. Assessment of therapeutic factors in groups is, however more complicated due to the many relationships in therapy groups. The Group Questionnaire is a promising empirically derived instrument intended to comprise important dimensions of a patient's relationship to his/her therapy group.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Borderline personality disorder or significant borderline traits

排除标准

  • •patients with psychotic disorders as their main problem
  • •Asperger's syndrome/autism spectrum disorders
  • •unregulated bipolar I disorders as their main problem

结局指标

主要结局

Toronto Alexithymia Scale, TAS-20, change during treatment and 3 months follow-up

时间窗: 6, 12, 18, 24, 30 and 36 months, and 3 months follow-up

alexithymia

Reflective functioning based on AAI, change from baseline to 3 months follow-up

时间窗: 3 months follow-up

reflective functioning

Reflective functioning based on the mentalization breakdown interview, change during treatment and 3 months follow-up

时间窗: 6, 12, 18, 24, 30 and 36 months, and 3 months follow-up

reflective functioning

Reflective functioning based on therapy sessions, change during treatment

时间窗: 6, 12, 18, 24, 30 and 36 months

reflective functioning

Months in work or studies, self report, change during treatment and 3 months follow-up

时间窗: 6, 12, 18, 24, 30 and 36 months, and 3 months follow-up

work functioning

Experiences in Close relationships, ECR, change during treatment and 3 months follow-up

时间窗: 6, 12, 18, 24, 30 and 36 months, and 3 months follow-up

attachment

Suicide ideation, change during treatment and 3 months follow-up

时间窗: 6, 12, 18, 24, 30 and 36 months, and 3 months follow-up

Suicide ideation

Work and Social Adjustments Scale, WSAS, change during treatment and 3 months follow-up

时间窗: 6, 12, 18, 24, 30 and 36 months, and 3 months follow-up

Work and social adaption

Global Assessment of Functioning, GAF, change during treatment and 3 months follow-up

时间窗: 6, 12, 18, 24, 30 and 36 months, and 3 months follow-up

psychosocial functioning

Patient Health Questionnaire, PHQ-9, change during treatment and 3 months follow-up

时间窗: 6, 12, 18, 24, 30 and 36 months, and 3 months follow-up

depression

Patient Health Questionnaire, GAD-7, change during treatment and 3 months follow-up

时间窗: 6, 12, 18, 24, 30 and 36 months, and 3 months follow-up

anxiety

Self-harm, self-report, change during treatment and 3 months follow-up

时间窗: 6, 12, 18, 24, 30 and 36 months, and 3 months follow-up

Self-harm

Suicide attempts, self-report, change during treatment and 3 months follow-up

时间窗: 6, 12, 18, 24, 30 and 36 months, and 3 months follow-up

Suicide attempts

Circumplex of Interpersonal Problems, CIP, change during treatment and 3 months follow-up

时间窗: 6, 12, 18, 24, 30 and 36 months, and 3 months follow-up

interpersonal problems

Level of Personality Functioning Scale, LPFS BF, change during treatment and 3 months follow-up

时间窗: 6, 12, 18, 24, 30 and 36 months, and 3 months follow-up

personality functioning

Difficulties in Emotion Regulation Scale, DERS, change during treatment and 3 months follow-up

时间窗: 6, 12, 18, 24, 30 and 36 months, and 3 months follow-up

emotional regulation

Severity Index of Personality Problems, SIPP-118, change during treatment and 3 months follow-up

时间窗: 6, 12, 18, 24, 30 and 36 months, and 3 months follow-up

personality functioning

次要结局

  • Substance use (from AUDIT and DUDIT), change during treatment and 3 months follow-up(6, 12, 18, 24, 30 and 36 months, and 3 months follow-up)
  • EuroQoL, EQ-5D, change during treatment and 3 months follow-up(6, 12, 18, 24, 30 and 36 months, and 3 months follow-up)
  • Modified Overt Aggression Scale (selected items), change during treatment and 3 months follow(6, 12, 18, 24, 30 and 36 months, and 3 months follow-up)
  • Working Alliance Inventory, WAI, change during treatment(6, 12, 18, 24, 30 and 36 months)
  • Group Questionnaire, GQ, change during treatment(6, 12, 18, 24, 30 and 36 months)
  • Client Satisfaction Scale, CSS, change during treatment and 3 months follow(6, 12, 18, 24, 30 and 36 months, and 3 months follow-up)
  • Health service use / NAV contacts and support, change during treatment and 3 months follow(6, 12, 18, 24, 30 and 36 months, and 3 months follow-up)

研究者

发起方
Oslo University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Theresa Wilberg

senior consultant and professor

Oslo University Hospital

研究点 (1)

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