Mindfulness Training in Adults With ADHD
Primary Purpose
ADHD
Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
MBCT for ADHD
Sponsored by
About this trial
This is an interventional treatment trial for ADHD focused on measuring MBCT, Mindfulness, ADHD
Eligibility 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
Sites / Locations
- Radboudumc
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Mindfulness Based Cognitive Therapy (MBCT) for ADHD
Treatment as usual (TAU)
Arm Description
Adapted MBCT for ADHD
Usually medication & psycho-education
Outcomes
Primary Outcome Measures
Change from baseline in investigator-rated ADHD symptoms
Conners Adult ADHD Scale, investigator rating scale (CAARS-IR)
Secondary Outcome Measures
Change from baseline in self-reported ADHD symptoms
Conners Adult ADHD Scale, self-report version (CAARS-S)
Change from baseline in executive functioning
Behavior Rating Inventory of Executive Function (BRIEF-A)
Change from baseline in patient functioning
Outcome Questionnaire 45.2 (OQ 45.2)
Change from baseline in mindfulness skills
Five Facet Mindfulness Questionnaire, short-form (FFMQ-SF)
Change from baseline in self-compassion
Self-Compassion Scale, short-form (SCS-SF)
Change from baseline in positive mental health
Mental Health Continuum, short-form (MHC-SF)
Change from baseline in health care consumption and productivity loss
Trimbos/iMTA questionnaire for Costs associated with Psychiatric illness (TiC-P)
Full Information
NCT ID
NCT02463396
First Posted
May 19, 2015
Last Updated
April 18, 2018
Sponsor
Radboud University Medical Center
Collaborators
ZonMw: The Netherlands Organisation for Health Research and Development
1. Study Identification
Unique Protocol Identification Number
NCT02463396
Brief Title
Mindfulness Training in Adults With ADHD
Official Title
Mindfulness Training Versus Treatment as Usual in Adults With Attention Deficit Hyperactivity Disorder (ADHD)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
September 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Radboud University Medical Center
Collaborators
ZonMw: The Netherlands Organisation for Health Research and Development
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ADHD
Keywords
MBCT, Mindfulness, ADHD
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mindfulness Based Cognitive Therapy (MBCT) for ADHD
Arm Type
Experimental
Arm Description
Adapted MBCT for ADHD
Arm Title
Treatment as usual (TAU)
Arm Type
No Intervention
Arm Description
Usually medication & psycho-education
Intervention Type
Behavioral
Intervention Name(s)
MBCT for ADHD
Primary Outcome Measure Information:
Title
Change from baseline in investigator-rated ADHD symptoms
Description
Conners Adult ADHD Scale, investigator rating scale (CAARS-IR)
Time Frame
baseline, 3, 6 and 9 months
Secondary Outcome Measure Information:
Title
Change from baseline in self-reported ADHD symptoms
Description
Conners Adult ADHD Scale, self-report version (CAARS-S)
Time Frame
baseline, 3, 6 and 9 months
Title
Change from baseline in executive functioning
Description
Behavior Rating Inventory of Executive Function (BRIEF-A)
Time Frame
baseline, 3, 6 and 9 months
Title
Change from baseline in patient functioning
Description
Outcome Questionnaire 45.2 (OQ 45.2)
Time Frame
baseline, 3, 6 and 9 months
Title
Change from baseline in mindfulness skills
Description
Five Facet Mindfulness Questionnaire, short-form (FFMQ-SF)
Time Frame
baseline, 3, 6 and 9 months
Title
Change from baseline in self-compassion
Description
Self-Compassion Scale, short-form (SCS-SF)
Time Frame
baseline, 3, 6 and 9 months
Title
Change from baseline in positive mental health
Description
Mental Health Continuum, short-form (MHC-SF)
Time Frame
baseline, 3, 6 and 9 months
Title
Change from baseline in health care consumption and productivity loss
Description
Trimbos/iMTA questionnaire for Costs associated with Psychiatric illness (TiC-P)
Time Frame
baseline, 3, 6 and 9 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
Radboudumc
City
Nijmegen
State/Province
Gelderland
ZIP/Postal Code
6525 GC
Country
Netherlands
12. IPD Sharing Statement
Citations:
PubMed Identifier
29486807
Citation
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.
Results Reference
derived
PubMed Identifier
26373634
Citation
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.
Results Reference
derived
Links:
URL
http://www.radboudcentrumvoormindfulness.nl/onderzoek/mindfulness-adhd/
Description
Website Radboud University Medical Centre for Mindfulness
Learn more about this trial
Mindfulness Training in Adults With ADHD
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