Effectiveness of Mentalization-based Therapy (MBT) as Part of a Stepped Mental Health Care in Finland - a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- Clinical Outcomes in Routine Evaluation - Outcome Measure (CORE-OM)
研究概览
简要总结
The effects of psychological treatment, mentalization-based therapy, will be studied among persons with mental disorders seeking help from mental health care services.
详细描述
Background: Mentalization-based therapy (MBT) has a growing evidence base as a group treatment, and research on MBT as an individual treatment is needed. This study will provide crucial new information on its effectiveness and usability in everyday patient care.
Methods: The study design will be an non-randomized clinical pilot study. We will study the effectiveness of MBT and analyze which factors are associated with better effectiveness. The length of intervention will be 12 months. The primary outcome measure is the change in psychological symptoms and well-being from the beginning to the end of MBT treatment, measured by CORE-OM. Secondary outcomes include several measures of symptoms, functioning, quality of life, and mentalization. Outcomes will be assessed at 6, 12 and 18 months. The study group will comprise of 64 patients receiving MBT. For comparison, patient group (n=64) with similar characteristics (age, gender, diagnosis) receiving treatment as usual (TAU) in psychiatric services will be ascertained from medical records, and their outcomes after 12 months of treatment will be compared to that of MBT -group.
Intervention / Treatment: Behavioral: Mentalization-based treatment/therapy
Participation criteria: Patients are not strictly limited to a specific disease/diagnostic group. This choice has been made because there is an increasing need in the mental health care for the treatment and therapy of this multi-symptom and severely symptomatic patient group, which also makes the results of the study more applicable to a real life. Patients will be selected for the MBT and TAU based on inclusion and exclusion criteria and patients preference. In addition, the selection to MBT will be made by a trained MBT therapist, who will assess the patient's suitability for MBT (e.g., patient willing to engage in active psychotherapeutic work, interested in the inner world of experience, willing to work interactively).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-64 years.
- •Severe psychological symptoms, decreased functioning ability for long-term
- •Challenges with interpersonal relationships and emotional regulation
- •Patients willing to receive MBT
- •At least two of the following:
- •Depression (diagnosis codes: F31.3-F31.5, F32.0-F32.9, F33.3-F33.9, F34.1) or anxiety disorder (diagnosis codes: F40-F48)
- •Trauma background either as diagnosis or as need for treatment
- •Signs of personality disorder (suspected or diagnosed)
- •Age 18-64 years.
- •Severe psychological symptoms, decreased functioning ability for long-term
- •Challenges with interpersonal relationships and emotional regulation
- •At least two of the following
- •Depression (diagnosis codes: F31.3-F31.5, F32.0-F32.9, F33.3-F33.9, F34.1) or anxiety disorder (diagnosis codes: F40-F48)
- •Trauma background either as diagnosis or as need for treatment
- •Signs of personality disorder (suspected or diagnosed)
排除标准
- •Active substance use disorder (i.e., intoxication F1x.0, active dependence F1x.24, Continuous use F1x.25), a physiological withdrawal state F1x.3 and F1x.4, or psychotic disorder F1x.5).
- •Acute psychosis (defined as the recent onset of severe psychotic symptoms that interfere with functioning and are not yet in a therapeutic state. Non-acute psychotic symptoms are not exclusionary)
- •Disorder requiring inpatient treatment
- •Previously received MBT
- •Currently receiving psychotherapeutic treatment (previous psychotherapeutic treatment is not an exclusion)
- •The exclusion criteria, therefore, do not exclude psychotic disorders or any other psychiatric illness (except substance abuse disorders).
- •Active substance use disorder (i.e., intoxication F1x.0, active dependence F1x.24, Continuous use F1x.25), a physiological withdrawal state F1x.3 and F1x.4, or psychotic disorder F1x.5).
- •Acute psychosis (defined as the recent onset of severe psychotic symptoms that interfere with functioning and are not yet in a therapeutic state. Non-acute psychotic symptoms are not exclusionary)
- •Disorder requiring inpatient treatment
- •Previously received MBT
- •Intensive psychotherapy (e.g. rehabilitative psychotherapy or similar weekly long-term psychotherapy)
结局指标
主要结局
Clinical Outcomes in Routine Evaluation - Outcome Measure (CORE-OM)
时间窗: baseline, 6, 12 and 18 months
A self-report measure of psychological distress and symptoms. Higher scores indicates worse outcomes. Includes four main domains: wellbeing, problems, functioning and risk (to self or others). Based on detailed instructions on calculating the scores, clinical score minimun 0 and maximum 40.
次要结局
- The Big Five Inventory-2 Extra-Short Form (BFI-2-XS)(baseline, 6, 12 and 18 months)
- the Inventory of Interpersonal Problems (IIP-32)(baseline, 6, 12 and 18 months)
- Experiences in Close Relationships Short version (ECR-S)(baseline, 6, 12, and 18 months)
- Rosenberg Self-Esteem Scale (RSE)(baseline, 6, 12, and 18 months)
- Emotion Regulation Questionnaire (ERQ)(baseline, 6, 12 and 18 months)
- The Certainty About Mental States Questionnaire (CAMSQ)(baseline, 6, 12 and 18 months)
- The Reflective Functioning Questionnaire (RFQ)(baseline, 6, 12 and 18 months)
- Quality of life(baseline, 6, 12 and 18 months)
- The Montgomery-Åsberg Depression Rating Scale (MADRS)(baseline, 12 months)
- Clinical Global Impression- Severity scale (CGI-S)(baseline, 12 months)
- Suicidality(from baseline to 18 months)
- Experiences of recovery(12 and 18 months)
- Social and Occupational Functioning Assessment Scale (SOFAS)(baseline, 12 months)
- Working Alliance Inventory (WAI)(baseline, 6 and 12 months)
- Patient experiences of the treatment(6 and 12 months)