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临床试验/NCT02463396
NCT02463396已完成不适用

Mindfulness Training Versus Treatment as Usual in Adults With Attention Deficit Hyperactivity Disorder (ADHD)

Radboud University Medical Center2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2014年9月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
120
试验地点
2
主要终点
Change from baseline in investigator-rated ADHD symptoms

研究概览

简要总结

The primary aim of this study is to investigate clinical effectiveness of mindfulness training versus treatment as usual (TAU) in adults with Attention Deficit Hyperactivity Disorder (ADHD). The secondary aim is to assess whether mindfulness training is cost-effective compared to TAU in adults with ADHD from a societal perspective.

详细描述

RATIONALE Attention Deficit Hyperactivity Disorder (ADHD) is a common neurodevelopmental disorder with a high persistence into adulthood. Patients with ADHD are primarily offered stimulant medication. However, not all patients are willing to take medication, some suffer from unacceptable side-effects and for many medication does not reduce their symptoms to the degree they would wish for. Therefore, there is a strong need for effective psychosocial interventions that are both accessible to a large group of patients and have been shown to be cost-effective, such as mindfulness training.

OBJECTIVE To examine the (cost)effectiveness of mindfulness versus treatment as usual (TAU) in adults with Attention Deficit Hyperactivity Disorder (ADHD).

HYPOTHESIS Mindfulness training will result in less ADHD symptoms, a better executive functioning, a better quality of life, and lower health care and societal costs.

STUDY DESIGN Randomised trial comparing mindfulness in addition to TAU with TAU alone. Baseline, end of treatment, follow-up 1 (6 months after baseline) and follow-up 2 (9 months after baseline) assessments will be done by blinded assessors and self-report questionnaires. After 9 months, patients allocated to the TAU condition will be offered mindfulness as well.

STUDY POPULATION N=120 adults with ADHD according to the DSM-5 using a structured psychiatric interview, referred to Radboudumc in Nijmegen, Reinier van Arkel in 's Hertogenbosch and Dimence in Deventer.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • The investigators will include patients of 18 years and older who meet the following criteria:
  • a primary diagnosis of ADHD, according to the criteria of Diagnostic and Statistical Manual of Mental Disorders - 4th edition (DSM-IV-TR) based on a structured Diagnostic Interview for ADHD, in adults (DIVA)
  • capable of filling out questionnaires in Dutch

排除标准

  • depressive disorder with psychotic symptoms or suicidality
  • active manic episode
  • borderline or antisocial personality disorder
  • substance dependence
  • autism spectrum disorder
  • tic disorder with vocal tics
  • learning difficulties or other cognitive impairments
  • former participation in a MBCT or MBSR course

研究组 & 干预措施

Mindfulness Based Cognitive Therapy (MBCT) for ADHD

Experimental

Adapted MBCT for ADHD

干预措施: MBCT for ADHD (Behavioral)

Treatment as usual (TAU)

No Intervention

Usually medication & psycho-education

结局指标

主要结局

Change from baseline in investigator-rated ADHD symptoms

时间窗: baseline, 3, 6 and 9 months

Conners Adult ADHD Scale, investigator rating scale (CAARS-IR)

次要结局

  • Change from baseline in self-reported ADHD symptoms(baseline, 3, 6 and 9 months)
  • Change from baseline in executive functioning(baseline, 3, 6 and 9 months)
  • Change from baseline in self-compassion(baseline, 3, 6 and 9 months)
  • Change from baseline in positive mental health(baseline, 3, 6 and 9 months)
  • Change from baseline in patient functioning(baseline, 3, 6 and 9 months)
  • Change from baseline in health care consumption and productivity loss(baseline, 3, 6 and 9 months)
  • Change from baseline in mindfulness skills(baseline, 3, 6 and 9 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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