Affect Consciousness (AC) as an Integrated add-on Component in Mentalization-based Group Treatment for Patients With Personality Disorder (PD)- a Mixed Method Explorative Study.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Changes in emotional dysfunction, ACI evaluation
研究概览
简要总结
Study background: Specialized Group Outpatient Clinic within specialist mental health services, tailoring two year group treatment programmes for severe Avoidant PD (AvPD) and Borderline PD (BPD) with Affect Consciousness (AC) targeting specific areas of emotional dysfunction. Aims: Our main hypothesis, adding AC to Mentalization- based treatment (MBT) to expand the breadth and depth of therapeutically productive work on affect, will aim to examine health indicators, processes and mechanisms of change in depth. The study will extracts preliminary data after 5 years and 10 years to investigate clinical change, variation and outcome during MBT for PD employing AC as add on to MBT. The study has a randomized controlled trail design, with MBT with or without AC as add-on. The RCT is grounded on original literature on Affect Theory, as a framework for understanding patient functioning, and MBT, framing the therapy.Implications: AC methodology as add on can lead to more tailored treatment programmes, service planning, allocation of resources, guidelines, ACI certification and method development for PDs.
详细描述
Randomized Controlled Trial (RCT) design from an observational longitudinal dataset. The study is part of the National Network of Personality Psychiatry. Repeated measurements of dependent variables during treatment will uncover how treatment conditions and dependent variables develop. The study's sample (N >300 from 2025-2035) is randomised into a two-group comparative design, 50% with AvPD and 50% with BPD will participate in an AC group as a supplement to MBT. 50% from each PD type will represent two control groups. The National Network of Personality Psychiatry (the Network) is providing systematic routines and clinical systems for facilitating quality PD assessment and evaluation during treatment, for outcome measures see table.
Analyses will be performed using IBM SPSS Statistics, Version 27.0. Advanced statistical methods for longitudinal analyses will mainly include linear mixed methods, both within- and between patient levels of prediction, with dependent variables based on patient- reported outcome measures, predictors and moderators based on clinical reported information on treatment condition and structured clinician evaluation of diagnoses.
The statistical power to detect a small to moderate effect size of d = 0.35 was estimated by statistician based on an expected drop-out rate of 12% with the necessary sample size for each group determined to be N 132. The level of statistical significance was set to 0.05. Using an independent samples t-test (one-tailed), our study's estimated power to identify the effect is 0.883 (or 88.3%).
A higher anticipated drop-out rate of 30%, adjusts sample size to N 105. The estimated power slightly decreases to 0.81, still surpasses the commonly accepted threshold of 0.80, suggesting sufficient power to detect a small to moderate effect.
Our choice of a one-tailed t-test aligns with the directional hypothesis that the group receiving AC in conjunction with MBT will show more beneficial effects than the control group.
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)
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participation in a MBT programme for severe AvPD and/or BPD 2025-
- •Half the participants join an AC group as add on to standard MBT based on randomisation on a cluster level, 25 % of the rest of the 50% representing the control group patientsample join an Body Awareness Group as add on to proper MBT and the last 25%, representering the control group participates in an Art psychotherapy group as add on to MBT, Norwegian language proficiency, age 20- 40 years.
排除标准
- •Diagnosed with schizotypal or antisocial PD, psychotic- or bipolar I disorder, pervasive developmental disorder, ongoing drug/ alcohol dependence, organically contingent symptoms and/or attention deficit hyperactivity disorder if not effectively treated with medication.
结局指标
主要结局
Changes in emotional dysfunction, ACI evaluation
时间窗: At time of inclusion (baseline), and at 6, 12, 18, and 24 months
The Affect Consciousness Interview (ACI), scale 1-9. Higher scores indicate more integrated and conscious affective functioning, whereas lower scores suggest difficulties in affect regulation or alexithymic traits.
Changes in emotional dysfunction, All self report
时间窗: At time of inclusion (baseline), and at 6, 12, 18, and 24 months
Self-report questionnaire: Affect Integration Inventory (AII), rating 112 items on a 10-point Likert scale (0 = does not fit at all, 9 = fits perfectly), where lower scores indicate lower affect integration across specific emotions.
Changes in emotional dysfunction, TAS-20 self report
时间窗: At time of inclusion (baseline), and at 6, 12, 18, and 24 months
Self-report questionnaire: Toronto Alexithymia Scale (TAS-20), rating 20 items on a 5-point Likert scale (1 = strongly disagree, 7 = strongly agree), where total scores: ≥61 = high alexithymia, 52-60 = possible alexithymia, ≤51 = non-alexithymic
Changes in emotional dysfunction, B-MAS self report
时间窗: At time of inclusion (baseline), and at 6, 12, 18, and 24 months
Self-report questionnaire: Brief Mentalized Affectivity Scale (B-MAS), rating 12 items on a 5-point Likert scale (1 = strongly disagree, 7 = strongly agree), where lower scores reflect suggest difficulties in affective self- reflection and regulation.
Changes in emotional dysfunction, DERS self report
时间窗: At time of inclusion (baseline), and at 6, 12, 18, and 24 months
Self-report questionnaire: Difficulties in Emotion Regulation Scale (DERS), rating 36 items on a 5-point Likert scale (1 = almost never, 7 = almost always), where higher scores reflect higher level of problems with regulating emotions.
Changes in personality functioning, LPFS-BF self-report
时间窗: At time of inclusion (baseline), and at 6, 12, 18, and 24 months
Self-report questionnaire: Level of Personality Functioning Scale - Brief Form 2.0 (LPFS-BF 2.0), rating 12 items on a 4-point Likert scale (0 = not at all true, 3 = completely true), where higher scores indicates higher levels of personality dysfunction.
Changes in personality functioning, SIPP-118 self-report
时间窗: At time of inclusion (baseline), and at 6, 12, 18, and 24 months
Self-report questionnaire: Severity Indices of Personality Problems - 118 (SIPP-118), ratring 118 items in a 4-point Likert scale (1 = fully disagree, 4 = fully agree), where higher scores reflect better adaptive personality functioning.
Changes in personality functioning, ECR self-report
时间窗: At time of inclusion (baseline), and at 6, 12, 18, and 24 months
Self-report questionnaire: Experiences in Close Relationships Scale (ECR), rating 36 items on a 7-point Likert scale (1 = strongly disagree, 7 = strongly agree), where higher scores indicate higher levels of attachment-related anxiety and attachment-related avoidance.
Changes in reflective functioning, RFQ-54 self report
时间窗: At time of inclusion (baseline), and at 6, 12, 18, and 24 months
Self-report questionnaire: Reflective Functioning Questionnaire (RFQ-54), rating 54 items on a 7-point Likert scale (1 = completely disagree to 7 = completely agree), where higher scores indicate reduced reflective functioning.
Role of attachment related trauma - AAI
时间窗: At time of inclusion (baseline), and at 6, 12 18 and 24 months
The Adult Attachment Interview (AAI) uses the AAI Scoring System related to: coherence of mind (scale 1-9), unresolved loss (scale 1-9), unresolved trauma (scale 1-9), idealization of parents (scale 1-9), anger and passivity (scale 1-9), derogation, fear, and lack of memory (scale 1-9), and classifies the individual into categories of: autonomous/secure, dismissing, preoccupied, or unresolved/disorganized. This is to determine the individual's state of mind regarding early attachment experiences and related trauma symptoms.
Changes in PTSD symptoms, PCL-5 self report
时间窗: At time of inclusion (baseline), and at 6, 12, 18, and 24 months
Self-report questionnaire: Post-Traumatic Stress Disorder Checklist for DSM-5 (PCL-5), rating 20 items 5-point Likert scale (0 = not at all, 4 = extremely), , where higher scores indicate higher levels of PTSD symptoms and a score ≥31 suggests probable PTSD diagnosis.
Changes in PTSD and C-PTSD symptoms, ITQ self report
时间窗: At time of inclusion (baseline) and at 24 months
Self-report questionnaire: International Trauma Questionnaire (ITQ), rating 18 items on a 5-point Likert scale (0 = not at all, 4 = extremely), evaluating symptoms of Post Traumatic Stress Disorder (PTSD) and Complex PTSD (CPTSD) and whether the individual have these diagnoses.
Traumatic childhood experience, CTQ self report
时间窗: At time of inclusion (baseline), and at 6, 12, 18, and 24 months
Self-report questionnaire: Childhood Trauma Questionnaire - Short Form (CTQ-SF), rating 28 items on a 5-point Likert scale (1 = never true, 5 = very often true), determining levels of early childhood maltreatment of emotional abuse, physical abuse, sexual abuse, emotional neglect and pysical neglect. Higher scores indicate greater exposure to developmental trauma.
Changes in subjective bodily experience and body image, SKO self report
时间窗: At time of inclusion (baseline), and at 6, 12, 18, and 24 months
Self-report questionnaire: Questionnaire of Body Experience (SKO), rating 64 items on a 6-point Likert scale (1 = never, 6 = All the time), where higher scores in negative dimensions indicates higher levels of dissociation, body alienation and/or trauma-related disturbances.
Changes in levels of anxiety, GAD-7 self report
时间窗: At time of inclusion (baseline) and at 24 months
Self-report questionnaire: Generalized Anxiety Disorder-7 (GAD-7), rating 7 items on a 4-point Likert scale (0 = not at all, 3 = nearly every day), where higher scores indicate higer levels of anxiety. A decrease of ≥4 points is considered a clinically significant improvement.
Changes in depression symptoms, PHQ-9 self report
时间窗: At time of inclusion (baseline) and at 24 months
Self-report questionnaire: Patient Health Questionnaire-9 (PHQ-9), rating 9 items on a 4-point Likert scale (0-3), where higher scores indicates higher levels of depression symptoms. A reduction of ≥5 points is considered clinically significant.
次要结局
未报告次要终点