Mindfulness Training in Adults With ADHD
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02463396|
Recruitment Status : Completed
First Posted : June 4, 2015
Last Update Posted : April 19, 2018
|Condition or disease||Intervention/treatment||Phase|
|ADHD||Behavioral: MBCT for ADHD||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
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
- 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)
- 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)
- Change from baseline in executive functioning [ Time Frame: baseline, 3, 6 and 9 months ]Behavior Rating Inventory of Executive Function (BRIEF-A)
- Change from baseline in patient functioning [ Time Frame: baseline, 3, 6 and 9 months ]Outcome Questionnaire 45.2 (OQ 45.2)
- Change from baseline in mindfulness skills [ Time Frame: baseline, 3, 6 and 9 months ]Five Facet Mindfulness Questionnaire, short-form (FFMQ-SF)
- Change from baseline in self-compassion [ Time Frame: baseline, 3, 6 and 9 months ]Self-Compassion Scale, short-form (SCS-SF)
- Change from baseline in positive mental health [ Time Frame: baseline, 3, 6 and 9 months ]Mental Health Continuum, short-form (MHC-SF)
- 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)
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
|Nijmegen, Gelderland, Netherlands, 6525 GC|