To examine the (cost)effectiveness of mindfulness versus treatment as usual (TAU) in adults with Attention Deficit Hyperactivity Disorder (ADHD).
ID
Source
Brief title
Condition
- Cognitive and attention disorders and disturbances
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
quality of life measured with the Outcome Questionnaire (OQ 45.2; Lambert et
al., 1996)
Secondary outcome
- investigator and self-report ADHD symptoms (CAARS-IR en CAARS-SV; Adler et
al., 2008)
- executive functioning (BRIEF-A; Goia et al., 2000)
- mindfulness skills (short form of the FFMQ; Bohlmeijer et al., 2011)
- self-compassion (short form of the SCS; Raes et al., 2011)
- health and well-being (SF-12; Ware et al., 1996)
- health care and societal costs (TiC-P; Institute for Medical Technology
Assessment, 2010)
- neuropsychological test battery containing of cognitive tasks all measuring
neurocognitive functions (Working memory task, Motivation x activation
reinforcement learning task, Probabilistic reversal learning task, Pavlovian to
instrumental transfer task, Demand selection task)
Background summary
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.
The current study aims at investigating whether individual mindfulness training
is superior to the usual treatment in terms of an improvement of quality of
life and executive functioning and a decrease of ADHD symptoms, health care and
societal costs.
Study objective
To examine the (cost)effectiveness of mindfulness versus treatment as usual
(TAU) in adults with Attention Deficit Hyperactivity Disorder (ADHD).
Study design
Randomised controlled trial comparing mindfulness in addition to TAU with TAU
alone. Baseline and end of treatment assessments, consisting of an interview
and online neuropsychological tests, will be done by blinded assessors and by
online self-report questionnaires. After 3 months, patients allocated to the
TAU condition will be offered mindfulness as well. At 3 and 6 months after
completion of the training, follow-up assessments will take place by online
self-report questionnaires.
Intervention
We have developed a treatment protocol of mindfulness for ADHD based on both
the MBCT (Mindfulness-Based Cognitive Therapy; Segal, Williams & Teasdale,
2013) and the MAPs-training (Mindful Awarenss Practices; Zylowska, 2012). This
intervention will be compared to the treatment as usual, usually consisting of
farmacotherapy with psychostimulants and psycho-education.
Study burden and risks
This study involves capacitated adults and examines a therapeutic intervention.
Participation is free of charge. There are no indications that there are risks
related to the intervention. During the training participants can become more
conscious of their ADHD related symptoms, like restlessness and a lack of
attention. This might be confronting for the participant. However, we do not
expect this to be harmful. Patients allocated to the mindfulness condition can
use their medication for ADHD during the intervention, like psychosimulants.
Participating in this study can be time consuming, as participants will be
interviewd, will perform neuropsychological tasks and will fill out several
questionnaires at different time points.
Reinier Postlaan 4
Nijmegen 6525 GC
NL
Reinier Postlaan 4
Nijmegen 6525 GC
NL
Listed location countries
Age
Inclusion criteria
In order to be eligible to participate in this study, a subject must meet all of the following criteria:
• Primary diagnosis of ADHD, according to the criteria of DSM-5 based on a structured psychiatric interview for ADHD (the DIVA)
• Willing to be randomized to either mindfulness training or treatment as usual only.
• Capable of filling out questionnaires in Dutch.
Exclusion criteria
A potential subject who meets any of the following criteria will be excluded from participation in this study:
• Being under 18 years of age
• Psychotic symptoms
• Depressive disorder with psychotic symptoms or suicidality
• Active manic episode
• Borderline or antisocial personality disorder
• Substance dependence
• Autistic disorder
• Tic disorder with vocal tics
• Learning difficulties or other cognitive impairments
• Not being able to understand or use the Dutch language
• Former participation in MBSR or MBCT
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL48776.091.14 |