NCT02463396

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

May 19, 2015

Completed
16 days until next milestone

First Posted

Study publicly available on registry

June 4, 2015

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

April 19, 2018

Status Verified

September 1, 2017

Enrollment Period

2 years

First QC Date

May 19, 2015

Last Update Submit

April 18, 2018

Conditions

ADHD

Keywords

MBCTMindfulnessADHD

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in investigator-rated ADHD symptoms

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

    baseline, 3, 6 and 9 months

Secondary Outcomes (7)

  • Change from baseline in self-reported ADHD symptoms

    baseline, 3, 6 and 9 months

  • Change from baseline in executive functioning

    baseline, 3, 6 and 9 months

  • Change from baseline in patient functioning

    baseline, 3, 6 and 9 months

  • Change from baseline in mindfulness skills

    baseline, 3, 6 and 9 months

  • Change from baseline in self-compassion

    baseline, 3, 6 and 9 months

  • +2 more secondary outcomes

Study Arms (2)

Mindfulness Based Cognitive Therapy (MBCT) for ADHD

EXPERIMENTAL

Adapted MBCT for ADHD

Behavioral: MBCT for ADHD

Treatment as usual (TAU)

NO INTERVENTION

Usually medication \& psycho-education

Interventions

MBCT for ADHDBEHAVIORAL
Mindfulness Based Cognitive Therapy (MBCT) for ADHD

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Radboudumc

Nijmegen, Gelderland, 6525 GC, Netherlands

Location

Related Publications (2)

  • 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.

    PMID: 29486807DERIVED

  • 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.

    PMID: 26373634DERIVED

Related Links

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 19, 2015

First Posted

June 4, 2015

Study Start

September 1, 2014

Primary Completion

September 1, 2016

Study Completion

September 1, 2017

Last Updated

April 19, 2018

Record last verified: 2017-09

Locations

NL(1)