Mindfulness-Based Behavioural Group Therapy for Adult Attention Deficit Hyperactivity Disorder - Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 发起方
- Peter Tonn
- 入组人数
- 180
- 试验地点
- 2
- 主要终点
- Change of Symptoms measured by the Connors ADHD Adult Rating Scale (CAARS)
研究概览
简要总结
The study is developed to validate a new short psychotherapeutic group treatment for adults with ADHD diagnosis. The participants will be treated in a monocentric, parallel group randomized superiority study - one group with the new treatment and one group with well established relaxing treatment.
详细描述
Background: Attention deficit hyperactivity disorder (AD(H)D) symptoms are often assumed to decease in adolescence, however in up to 60% of children, AD(H)D persists into adulthood. Currently, pharmacological therapy is the number-one choice AD(H)D treatment. Despite its evidenced effects of pharmacological interventions there are side effects, contraindications and non-responders, which send some patients disliking the use of medication and asking for alternative treatments. In previous studies mindfulness-based interventions already have shown similar effects in neural regions as pharmacological treatment and positive changes in AD(H)D symptoms, quality of life, awareness and concentration. The following study wants to improve mindfulness-based treatment approaches in AD(H)D with a new therapy concept.
Methods: Mindfulness, acceptance, commitment and cognitive behavioral group therapy (MAC-CBT) combines 3rd wave therapies with focus on mindfulness meditation, acceptance of unchangeability, commitment to new goals with elements of cognitive behavioral therapy. The design of this study is a single-center, parallel-group, randomized superiority trial. The aim is to compare MAC-CBT group with progressive muscle relaxation training (PMR by Jacobson). Both groups will be held over a period of eight weeks. Participants will be assessed two times before treatment to determine natural course of adult AD(H)D and two times after treatment to evaluate short and long term effects. A questionnaire battery and neuropsychological tests are to be used to obtain results regarding a possible change in the symptoms and attention, including selective attention.
Discussion: This trial will offer new knowledge about the effects of third wave therapies on AD(H)D. Furthermore, the following study is one of few studies that will compare AD(H)D treatment to relaxation training instead of comparison to waiting list. The aim of the following study is to verify previous outcomes of mindfulness-based treatments on AD(H)D and to evaluate superiority of mindfulness towards relaxation programs.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
The participants will not know, in which of the arms they are; the outcomes assessor did not know the patients study-arm
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
- •adult ADHD
- •written informed consent
- •stable medication for at least two weeks
- •sufficient knowledge of the German language
排除标准
- •personality disorder
- •schizophrenia / psychotic disorders
- •bipolar disorder
- •acute suicidality
- •disease of the central nervous system
- •no other psychotherapeutic treatment at the time of the study
- •pregnancy
- •IQ below 70 Points
结局指标
主要结局
Change of Symptoms measured by the Connors ADHD Adult Rating Scale (CAARS)
时间窗: Measurement 1 at inclusion date, Measurement 2 two months later measurement 1, then measurement 3 immediately after intervention, measurement 4 as catamnestic follow up 6 months after intervention
The long version of the CAARS (Conner's Adult AD(H)D Rating Scales (Christiansen et al., 2012)) combines self-report and observer rating questionnaires to assess current AD(H)D symptoms in adulthood. This instrument consists of 66 items based on a 4-point Likert scale and four subscales: Inattention/ Memory Problems, Hyperactivity/ Restlessness, Impulsivity/ Emotional Lability and Problems with Self-Concept. With regard to the scientific quality criteria, Christiansen (2012) reports internal consistencies with a Cronbach's α of .74 to .95 and a test-retest reliability from .71 to .93, range min. 66 to max. 264 points.
次要结局
- Measure of the quality of life of the participants measured by World Health Organization Quality of Life Questionnaire(Measurement 1 at inclusion date, Measurement 2 two months later measurement 1, then measurement 3 immediately after intervention, measurement 4 as catamnestic follow up 6 months after intervention)
- Changes of acceptance, measured by Acceptance and Action Questionnaire(Measurement 1 at inclusion date, Measurement 2 two months later measurement 1, then measurement 3 immediately after intervention, measurement 4 as catamnestic follow up 6 months after intervention)
- Measuring of satisfaction and willingness to change with visual analogue scales(Measurement 1 at inclusion date, Measurement 2 two months later measurement 1, then measurement 3 immediately after intervention, measurement 4 as catamnestic follow up 6 months after intervention)
- Measuring of five individual parameters during every of the single treatment session(Measurement before and after every treatment session, 2-6 weeks after inclusion date, every week for the 8 weeks treatment period)
- Changes of attention functioning measured by change detection task and trail making test A and B of the computer based test setting Psychology Experiment Building Language (PEBL)(Measurement 1 at inclusion , Measurement 2 is 2 months after inclusion, measurement 3 immediately after intervention, measurement 4 as catamnestic follow up 6 months after intervention)
- Changes of mindfulness measured by Mindful Attention Awareness Scale(Measurement 1 at inclusion date, Measurement 2 two months later measurement 1, then measurement 3 immediately after intervention, measurement 4 as catamnestic follow up 6 months after intervention)
- Affective state measured with the Patient Health Questionnaire PHQ-9(Measurement 1 at inclusion date, Measurement 2 two months later measurement 1, then measurement 3 immediately after intervention, measurement 4 as catamnestic follow up 6 months after intervention)
研究者
Peter Tonn
Director of the Center
Neuropsychiatrischen Zentrums Hamburg-Altona