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OpenTrials
Completed

NCT Number: NCT02463396

Mindfulness Training in Adults With ADHD

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Radboudumc

Nijmegen, Gelderland, 6525 GC, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MBCT for ADHD

Behavioral

Primary outcomes

  1. Change from baseline in investigator-rated ADHD symptoms

    Time frame: baseline, 3, 6 and 9 months

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

Secondary outcomes

  1. Change from baseline in self-reported ADHD symptoms

    Time frame: baseline, 3, 6 and 9 months

    Conners Adult ADHD Scale, self-report version (CAARS-S)

  2. Change from baseline in executive functioning

    Time frame: baseline, 3, 6 and 9 months

    Behavior Rating Inventory of Executive Function (BRIEF-A)

  3. Change from baseline in patient functioning

    Time frame: baseline, 3, 6 and 9 months

    Outcome Questionnaire 45.2 (OQ 45.2)

  4. Change from baseline in mindfulness skills

    Time frame: baseline, 3, 6 and 9 months

    Five Facet Mindfulness Questionnaire, short-form (FFMQ-SF)

  5. Change from baseline in self-compassion

    Time frame: baseline, 3, 6 and 9 months

    Self-Compassion Scale, short-form (SCS-SF)

  6. Change from baseline in positive mental health

    Time frame: baseline, 3, 6 and 9 months

    Mental Health Continuum, short-form (MHC-SF)

  7. Change from baseline in health care consumption and productivity loss

    Time frame: baseline, 3, 6 and 9 months

    Trimbos/iMTA questionnaire for Costs associated with Psychiatric illness (TiC-P)

Sponsors and collaborators

Lead sponsor

Radboud University Medical Center

Other

Collaborators

  • ZonMw: The Netherlands Organisation for Health Research and Development

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2017
First posted
Jun 4, 2015
Registry last updated
Apr 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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