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ADHDNCT02463396

Mindfulness Training in Adults With ADHD

A study testing MBCT for ADHD in people with ADHD, run by Radboud University Medical Center at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
ADHD
What is being tested?
MBCT for ADHD
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
1 siteNetherlands
Study dates
Sep 2014to Sep 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

  • Radboudumc

    Nijmegen, Gelderland, 6525 GC

Other trials in Netherlands

About this study

Official title: 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.

Read the 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.

Conditions
ADHD
Being tested
MBCT for ADHD
Keywords
MBCT, Mindfulness, ADHD
Medical subject headings
Attention Deficit Disorder with Hyperactivity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MBCT for ADHDBehavioural

Study groups in NCT02463396
Study groupRoleWhat they receive
Mindfulness Based Cognitive Therapy (MBCT) for ADHDExperimentalAdapted MBCT for ADHD
Receives: Behavioral: MBCT for ADHD
Treatment as usual (TAU)No interventionUsually medication \& psycho-education

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from baseline in investigator-rated ADHD symptoms

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

    Measured: baseline, 3, 6 and 9 months

Secondary outcomes (7)

  1. Change from baseline in self-reported ADHD symptoms

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

    Measured: baseline, 3, 6 and 9 months

  2. Change from baseline in executive functioning

    Behavior Rating Inventory of Executive Function (BRIEF-A)

    Measured: baseline, 3, 6 and 9 months

  3. Change from baseline in patient functioning

    Outcome Questionnaire 45.2 (OQ 45.2)

    Measured: baseline, 3, 6 and 9 months

  4. Change from baseline in mindfulness skills

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

    Measured: baseline, 3, 6 and 9 months

  5. Change from baseline in self-compassion

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

    Measured: baseline, 3, 6 and 9 months

  6. Change from baseline in positive mental health

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

    Measured: baseline, 3, 6 and 9 months

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

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

    Measured: baseline, 3, 6 and 9 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jun 2015 (estimated)
  2. Study startSep 2014
  3. Primary completionSep 2016
  4. Study completionSep 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02463396
Sponsor's protocol ID
NL48776.091.14
Other IDs
837001501
Status last verified
Sep 2017
First submitted
19 May 2015
Last updated
19 Apr 2018
Results posted
No
Data monitoring committee
No

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.

    PubMed 29486807

  • 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.

    PubMed 26373634

Questions about this trial

What is this clinical trial studying?

A study testing MBCT for ADHD in people with ADHD, run by Radboud University Medical Center at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in investigator-rated ADHD symptoms (time frame: baseline, 3, 6 and 9 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02463396, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2018.

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