Cost-effectiveness of Schema Therapy for Treatment-resistant Anxiety Disorders: A Multicentre RCT
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 172
- 主要终点
- Health care utilization and productivity losses
研究概览
简要总结
The aim of this study is to assess the cost-effectiveness of schema therapy compared to treatment as usual (TAU) in patients with treatment-resistant anxiety disorders. In a multicenter randomized controlled trial, patients will be assigned to receive individual schema therapy (maximum of 40 sessions) or treatment as usual (control group) within one year. The primary outcome is the difference between ST and TAU conditions in anxiety symptoms as measured with the Beck Anxiety Inventroy (BAI) at post treatment. Secondary outcomes include quality of life, societal costs, general mental health, remission from the anxiety disorders and/or comorbid affective disorders, positive and negative effects of psychotherapy, schemas and schema modes, and satisfaction. Measurements take place at baseline and after 1, 3, 6, 12, 24 and 36 months (follow-up of two years).
详细描述
RATIONALE Although treatment for anxiety disorders is generally (cost-)effective, a significant proportion of 30 to 60% of patients does not adequately respond to first-line treatments (i.e. cognitive behavioral therapy (CBT) and antidepressants). This patient group remains significantly impaired. A next-step psychotherapy focusing on underlying vulnerability is urgently needed.
OBJECTIVE To evaluate the cost-effectiveness of individual schema therapy (max. 40 sessions) versus treatment as usual in patients with treatment-resistant anxiety disorders from a societal perspective.
STUDY DESIGN Multicenter randomized controlled trial with a cost-effectiveness analysis and an embedded process evaluation. The project title "PaDoLA" refers to "PAtronen DOorbreken bij Langdurige Angst" in Dutch, which translates to "breaking patterns in chronic anxiety".
STUDY POPULATION Adults (18-65 years) with treatment-resistant DSM-5 anxiety disorders recruited in specialized mental health care. Treatment-resistance is defined as (at least) one failed trial of > 8 weeks CBT plus one failed trial of a serotonergic antidepressant for > 8 weeks plus persistence of anxiety symptoms.
INTERVENTION Intervention group: Individual schema therapy with max. 40 sessions within one year. Schema therapy is an integrative psychotherapy, with a high emphasis on the therapeutic relationship ("limited reparenting"), use of trauma focused techniques, experiential and cognitive techniques, role-play and behavioral exercises. The treatment protocol used in this study is adapted specifically for patients with treatment-resistant anxiety disorders.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary diagnosis of an anxiety disorder (panic disorder, agoraphobia, social anxiety disorder, generalized anxiety disorder, separation anxiety disorder and specific phobia) based on the Diagnostic and Statistical Manual of Mental Disorders (DSM-5).
- •Fulfilling the criteria of treatment-resistance based on a systematic literature search by Bokma and collegues: i) at least one unsuccessful CBT treatment of ≥ 8 weeks; and ii) at least one unsuccessful pharmacological treatment with a serotonergic antidepressant of ≥ 8 weeks, and iii) moderate to severe anxiety symptoms (BAI > 11). The adequacy of previous treatment will be checked.
排除标准
- •Substance use dependence
- •Acute suicidality
- •Has received schema therapy in the past
- •Has insufficient language skills in Dutch and/or English
研究组 & 干预措施
Treatment As Usual (TAU)
Treatment as usual in treatment-resistant anxiety disorders (psychological and/or psychiatric).
干预措施: TAU (Other)
结局指标
主要结局
Health care utilization and productivity losses
时间窗: Baseline and at 1, 3, 6, 12, 24 and 36 months after baseline.
Health care utilization and productivity losses, which are used for the cost-utility analysis, are assessed with the 57-item, self-report Treatment Inventory of Costs in Patients with psychiatric disorders (TiC-P). The TiC-P measures two dimensions: health care use in psychiatric patients and (voluntary) work and care tasks. The IMTA Productivity Cost Questionnaire (iPCQ) is part of the TiC-P questionnaire and measures absenteeism, presenteeism and productivity loss in unpaid work.
Changes in the severity of anxiety symptoms
时间窗: Screening, baseline and at 1, 3, 6, 12, 24 and 36 months after baseline.
Changes in the severity of anxiety symptoms are measured with the 21-item self-report Beck Anxiety Inventory (BAI), assessing somatic and affective-cognitive symptom domains. The total score ranges from 0 to 63, with higher scores indicating more severe anxiety symptoms. A score above 11 indicates clinically significant symptoms.
Health-related quality of life
时间窗: Baseline and at 1, 3, 6, 12, 24 and 36 months after baseline.
Health-related quality of life, which is used for the cost-utility analysis, is assessed with the 5-item, self-report Health-Related Quality of Life Measure Euroqol (EQ5D-5L). The EQ5D-5L measures five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The dimension scores can be translated into a single index value. Additionally, the EQ5D-5L estimates the general self-reported health-related quality of life on a visual analogue scale, ranging from 0 (worst quality of life) to 100 (best quality of life).
Mental health quality of life
时间窗: Baseline and at 1, 3, 6, 12, 24 and 36 months after baseline.
Mental health quality of life, which is used for the cost-utility analysis, is measured with the 7-item, self-report Mental Health Quality of Life (MHQoL). The MHQoL encompasses seven dimensions: self-image, independence, mood, relationships, daily activities, physical health and hope. Total scores range from 0 to 21, with higher scores indicating better quality of life. In addition, the MHQoL assesses self-reported general psychological well-being on a visual analogue scale, ranging from 0 (low well-being) to 10 (high well-being).
次要结局
- Demographics(Baseline)
- Schema Modes(Baseline and at 3, 6, 12 and 36 months after baseline.)
- Remission from the primary anxiety disorder and from comorbid disorders(Baseline, and at 12, 24 and 36 months after baseline.)
- Assessment of DSM-5 personality disorders(Baseline)
- Screening for DSM-5 personality disorders(Baseline and at 1, 3, 6, 12, 24 and 36 months after baseline.)
- (Strength of) treatment preference(Baseline and at 12 months after baseline.)
- Assessment of autistic traits(Baseline)
- Assessment of childhood trauma(Baseline)
- Assessment of general mental health(Baseline and at 12, 24 and 36 months after baseline.)
- Functioning and recovery in psychiatric patients(Baseline and 12, 24 and 36 months after baseline.)
- Early Maladaptive Schemas(Baseline and at 12 and 36 months after baseline.)
- Positive and negative effects of psychotherapy(At 12 months after baseline.)
- The level of satisfaction with the psychological treatment(At 12 months after baseline.)
研究者
Anna Muntingh
PhD
Amsterdam UMC, location VUmc