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Mindfulness Training in Adults With ADHD

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ClinicalTrials.gov Identifier: NCT02463396
Recruitment Status : Completed
First Posted : June 4, 2015
Last Update Posted : April 19, 2018
Sponsor:
Collaborator:
ZonMw: The Netherlands Organisation for Health Research and Development
Information provided by (Responsible Party):
Radboud University Medical Center

Study Description
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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.

Condition or disease Intervention/treatment Phase
ADHD Behavioral: MBCT for ADHD Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Mindfulness Training Versus Treatment as Usual in Adults With Attention Deficit Hyperactivity Disorder (ADHD)
Study Start Date : September 2014
Actual Primary Completion Date : September 2016
Actual Study Completion Date : September 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02463396


Locations
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Netherlands
Radboudumc
Nijmegen, Gelderland, Netherlands, 6525 GC
Sponsors and Collaborators
Radboud University Medical Center
ZonMw: The Netherlands Organisation for Health Research and Development
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Radboud University Medical Center
ClinicalTrials.gov Identifier: NCT02463396    
Other Study ID Numbers: NL48776.091.14
837001501 ( Other Grant/Funding Number: ZonMw )
First Posted: June 4, 2015    Key Record Dates
Last Update Posted: April 19, 2018
Last Verified: September 2017
Keywords provided by Radboud University Medical Center:
MBCT
Mindfulness
ADHD