Clinical Effectiveness and Cost-effectiveness of Mindfulness-Based Cognitive Therapy (MBCT) for Depressed Non-responders to Increasing Access to Psychological Therapies (IAPT) High-intensity Therapies
试验速览
- 阶段
- 不适用
- 入组人数
- 234
- 试验地点
- 4
- 主要终点
- Patient Health Questionnaire-9 (PHQ-9) at 34-weeks post-randomisation
研究概览
简要总结
If not treated sufficiently, Major Depression tends to take a recurrent or chronic lifetime course that is associated with a significantly increased risk for physical and neurodegenerative disorders. In England, Increasing Access to Psychological Therapies (IAPT) services provide evidence-based treatment for patients with common mental disorder with an access rate intended to rise to 25% of this population by 2021. However, about 50% of the depressed patients who come to the end of this pathway, have not responded sufficiently. Mindfulness-Based Cognitive Therapy, a treatment combining training in mindfulness meditation and components from cognitive therapy, has previously been shown to be effective in treatment non-responders, but further evidence is needed to establish this finding more definitively and to see whether positive effects can be achieved within the stepped care approach of IAPT.
In order to address these issues, this study will investigate whether MBCT can effectively reduce symptoms and lead to sustained recovery in patients suffering from Major Depressive Disorder who have not sufficiently responded to high-intensity evidence-based therapy and have thus come to the end of the Increasing Access to Psychological Therapies (IAPT) care pathway. It will also test whether the introduction of this treatment can reduce subsequent service use.
The investigators will randomly allocate 234 patients who have not sufficiently responded to IAPT high-intensity therapy to take part either in MBCT or to continue with TAU in a three-centre (London, Exeter, Sussex) RCT. Reductions in depression symptomatology will be assessed using the Patient Health Questionnaire-9, a standard measure of the severity of depression used in IAPT treatment monitoring, at 10-week (secondary outcome) and 34-week follow-up post-randomisation (primary outcome). Service-use information will be collected using the Adults Service Use Schedule. If successful, the current project would provide the necessary evidence base for the introduction of MBCT for IAPT high-intensity non-responders.
详细描述
Major Depression represents a pressing challenge for health care. The disorder is not only highly prevalent but also shows many characteristics of a progressive disorder. If not treated sufficiently, it tends to become more recurrent and chronic over time.
In order to address this challenge, it is imperative to provide treatments that effectively reduce symptoms in those who are affected. In England and other parts of the United Kingdom, Increasing Access to Psychological Therapies (IAPT) services have been introduced with the aim of providing evidence-based psychological therapies in a timely manner. While the introduction of these services has successfully increased access to psychological therapies, outcome reports indicate that about 50% of the depressed patients who have completed high-intensity evidence-based psychological therapies within IAPT do not reach recovery and continue to show significant levels of symptoms. At the same time, progression to secondary care remains reserved for those with complex depression and high risk for suicidality.
Mindfulness-Based Cognitive Therapy (MBCT), an eight-week, group-based intervention that combines intensive training in mindfulness and elements from cognitive therapy for depression, may be particularly suited for addressing this gap. While originally developed, for the prevention of relapse in remitted patients with a history of recurrent depression, recent research has brought promising evidence that MBCT can have significant beneficial effects in patients with acute symptoms, and particularly in those who have not responded to previous interventions. However, evidence is currently not sufficient to warrant endorsement for use as a further-line treatment within the evidence-based IAPT pathway.
In order to justify and enable this use, research needs to provide evidence from a further definitive trial. Moreover, previous research investigating MBCT as a further-line treatment has been conducted exclusively in non-responders to antidepressant medication. In order to provide representative estimates of benefits for inclusion in IAPT, research will have to test clinical effectiveness following psychological therapy and demonstrate its cost-effectiveness within this particular pathway.
This study will compare MBCT to treatment-as-usual (TAU) in IAPT high-intensity treatment non-responders in a definitive clinical trial. We will test the immediate effects of the intervention on depressive symptomatology as well as whether effects on symptomatology can be sustained over a period of six months, thus taking into account the high risk of relapse in early stages following treatment. In addition to testing clinical effectiveness, the investigators will measure service use and collect information on quality of life in order to provide information on the cost effectiveness of the intervention in IAPT high-intensity treatment non-responders.
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
- None
盲法说明
Use of remote assessments, initiated through automated email, will rule out any potential effects of assessors on assessments of outcomes. The statisticians will remain blind to treatment allocation throughout the analysis.
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Patient Health Questionnaire-9 (PHQ-9) at 34-weeks post-randomisation
时间窗: 34 weeks post-randomisation
Depressive symptomatology at 34-weeks post-randomisation as assessed using the Patient Health Questionnaire-9 (PHQ-9). Scores on the PHQ-9 can range from 0 to 27 with higher scores indicating more severe depression.
次要结局
- Patient Health Questionnaire-9 (PHQ-) at 10-weeks post-randomisation(10 weeks post-randomisation)
- Work and Social Adjustment Scale(10 weeks and 34 weeks post-randomisation)
- A series of binarised outcomes based on PHQ-9 and GAD-7(34 weeks post-randomisation)
- Phobia Scale(10 weeks and 34 weeks post-randomisation)
- Generalized Anxiety Disorder Questionnaire (GAD-7)(10 weeks and 34 weeks post-randomisation)
- Five Factor Mindfulness Questionnaire (Short Form)(10 weeks and 34 weeks post-randomisation)
- Warwick-Edinburgh Mental Wellbeing Scale(10 weeks and 34 weeks post-randomisation)
- Experiences Questionnaire(10 weeks and 34 weeks post-randomisation)