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.
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. INTERVENTION The investigators have developed a treatment protocol of mindfulness for ADHD based on both the Mindfulness-Based Cognitive Therapy (MBCT) (Segal, Williams \& Teasdale, 2013) and the mindfulness training for ADHD developed by Zylowska (2012). STANDARD INTERVENTION TO BE COMPARED TO Treatment as usual, usually consisting of psychostimulants and psycho-education. COST-EFFECTIVENESS ANALYSIS/ BUDGET IMPACT ANALYSIS Annual health care and societal cost savings are expected to be €1,2 million and €15,4 million, respectively.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
120
Radboudumc
Nijmegen, Gelderland, Netherlands
Change from baseline in investigator-rated ADHD symptoms
Conners Adult ADHD Scale, investigator rating scale (CAARS-IR)
Time frame: baseline, 3, 6 and 9 months
Change from baseline in self-reported ADHD symptoms
Conners Adult ADHD Scale, self-report version (CAARS-S)
Time frame: baseline, 3, 6 and 9 months
Change from baseline in executive functioning
Behavior Rating Inventory of Executive Function (BRIEF-A)
Time frame: baseline, 3, 6 and 9 months
Change from baseline in patient functioning
Outcome Questionnaire 45.2 (OQ 45.2)
Time frame: baseline, 3, 6 and 9 months
Change from baseline in mindfulness skills
Five Facet Mindfulness Questionnaire, short-form (FFMQ-SF)
Time frame: baseline, 3, 6 and 9 months
Change from baseline in self-compassion
Self-Compassion Scale, short-form (SCS-SF)
Time frame: baseline, 3, 6 and 9 months
Change from baseline in positive mental health
Mental Health Continuum, short-form (MHC-SF)
Time frame: baseline, 3, 6 and 9 months
Change from baseline in health care consumption and productivity loss
Trimbos/iMTA questionnaire for Costs associated with Psychiatric illness (TiC-P)
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Time frame: baseline, 3, 6 and 9 months