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Mindfulness Training in Adults With ADHD

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02463396
Enrollment
120
Registered
2015-06-04
Start date
2014-09-30
Completion date
2017-09-30
Last updated
2018-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ADHD

Keywords

MBCT, Mindfulness, ADHD

Brief summary

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.

Detailed description

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.

Interventions

BEHAVIORALMBCT for ADHD

Sponsors

ZonMw: The Netherlands Organisation for Health Research and Development
CollaboratorOTHER
Radboud University Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Change from baseline in investigator-rated ADHD symptomsbaseline, 3, 6 and 9 monthsConners Adult ADHD Scale, investigator rating scale (CAARS-IR)

Secondary

MeasureTime frameDescription
Change from baseline in executive functioningbaseline, 3, 6 and 9 monthsBehavior Rating Inventory of Executive Function (BRIEF-A)
Change from baseline in patient functioningbaseline, 3, 6 and 9 monthsOutcome Questionnaire 45.2 (OQ 45.2)
Change from baseline in mindfulness skillsbaseline, 3, 6 and 9 monthsFive Facet Mindfulness Questionnaire, short-form (FFMQ-SF)
Change from baseline in self-reported ADHD symptomsbaseline, 3, 6 and 9 monthsConners Adult ADHD Scale, self-report version (CAARS-S)
Change from baseline in positive mental healthbaseline, 3, 6 and 9 monthsMental Health Continuum, short-form (MHC-SF)
Change from baseline in health care consumption and productivity lossbaseline, 3, 6 and 9 monthsTrimbos/iMTA questionnaire for Costs associated with Psychiatric illness (TiC-P)
Change from baseline in self-compassionbaseline, 3, 6 and 9 monthsSelf-Compassion Scale, short-form (SCS-SF)

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026