Mindfulness Training in Adults With ADHD

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

Study Overview

• Status: Completed
• Conditions: ADHD
• Intervention / Treatment: Behavioral: MBCT for ADHD

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.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Gelderland
    • Nijmegen, Gelderland, Netherlands, 6525 GC
      • Radboudumc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mindfulness Based Cognitive Therapy (MBCT) for ADHD; Adapted MBCT for ADHD	Behavioral: MBCT for ADHD
No Intervention: Treatment as usual (TAU); Usually medication & psycho-education

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in investigator-rated ADHD symptoms	Conners Adult ADHD Scale, investigator rating scale (CAARS-IR)	baseline, 3, 6 and 9 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in self-reported ADHD symptoms	Conners Adult ADHD Scale, self-report version (CAARS-S)	baseline, 3, 6 and 9 months
Change from baseline in executive functioning	Behavior Rating Inventory of Executive Function (BRIEF-A)	baseline, 3, 6 and 9 months
Change from baseline in patient functioning	Outcome Questionnaire 45.2 (OQ 45.2)	baseline, 3, 6 and 9 months
Change from baseline in mindfulness skills	Five Facet Mindfulness Questionnaire, short-form (FFMQ-SF)	baseline, 3, 6 and 9 months
Change from baseline in self-compassion	Self-Compassion Scale, short-form (SCS-SF)	baseline, 3, 6 and 9 months
Change from baseline in positive mental health	Mental Health Continuum, short-form (MHC-SF)	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)	baseline, 3, 6 and 9 months

Collaborators and Investigators

• Sponsor: Radboud University Medical Center
• Collaborators: ZonMw: The Netherlands Organisation for Health Research and Development

Publications and helpful links

General Publications

• Janssen L, Kan CC, Carpentier PJ, Sizoo B, Hepark S, Schellekens MPJ, Donders ART, Buitelaar JK, Speckens AEM. Mindfulness-based cognitive therapy v. treatment as usual in adults with ADHD: a multicentre, single-blind, randomised controlled trial. Psychol Med. 2019 Jan;49(1):55-65. doi: 10.1017/S0033291718000429. Epub 2018 Feb 28. Erratum In: Psychol Med. 2018 Aug;48(11):1920.
• Janssen L, Kan CC, Carpentier PJ, Sizoo B, Hepark S, Grutters J, Donders R, Buitelaar JK, Speckens AE. Mindfulness based cognitive therapy versus treatment as usual in adults with attention deficit hyperactivity disorder (ADHD). BMC Psychiatry. 2015 Sep 15;15:216. doi: 10.1186/s12888-015-0591-x.

Helpful Links

• Website Radboud University Medical Centre for Mindfulness

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Actual): September 1, 2016
• Study Completion (Actual): September 1, 2017

Study Registration Dates

• First Submitted: May 19, 2015
• First Submitted That Met QC Criteria: June 2, 2015
• First Posted (Estimate): June 4, 2015

Study Record Updates

• Last Update Posted (Actual): April 19, 2018
• Last Update Submitted That Met QC Criteria: April 18, 2018
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Keywords: ADHD; Mindfulness; MBCT
• Other Study ID Numbers: NL48776.091.14; 837001501 (Other Grant/Funding Number: ZonMw)