To study the effects of Mindfulness training in adults with ADHD on ADHD symptoms and comorbidity with affective and anxiety symptoms. Also, the feasibility of Mindfulness training will be evaluated in this specific patientgroup and the effect on…
ID
Source
Brief title
Condition
- Cognitive and attention disorders and disturbances
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Conners' Adult ADHD Rating Scale-Investigator Rated: Screening Version
(16)18-item Total ADHD symptoom score is the primary outcome measure
Secondary outcome
Conners' Adult ADHD Rating Scale Observer Screening Version (CAARS-O-S)(16) 18
item total ADHD symptoom score, ADHD index, ADHD inattentive subscale, ADHD
hyperactivity/impulsivity subscale
Conners' Adult ADHD Rating Scale Self Report Screening Version (CAARS-S-S) (15)
18 item total ADHD symptoom score ADHD index, ADHD inattentive subscale, ADHD
hyperactivity/impulsivity subscale
Beck Depression Inventory (11) Total BDI II-NL score
STAI anxiety (12,13) Total STAI Anxiety score
Mindfulness vragenlijst (FFMQ)(17) Total Mindfulness Ouestionnaire score
Outcome questionnaire (OQ) (15) Total OQ score
Attention Network Test (ANT) 15 min (18) conflict effect, orienting effect,
alerting effect, Mean Reaction Time for Correct Trials
32 channels Electroencephalogram 60 min (EEG) (19,20) frequency bands; theta
power: 3,5-7,5 Hz; alpha power: 7,5-12,5 Hz; beta power: 12,5-25 Hz
Background summary
Attention Deficit Hyperactivity Disorder (ADHD) is a childhood-onset
psychiatric condition that often continues into adulthood. Yet there is an
continued interest in novel non-pharmacological interventions besides
pharmacological treatment in ADHD to optimize outcomes for patients.
Mindfulness trainingsprogram has emerged as a new approach for stress reduction
and an important innovation in treating psychiatric disorders such as to
prevent relapse by recurrent depressive disorders and anxiety disorders. A
recent feasibility study has shown positieve outcomes for ADHD symptoms.
Study objective
To study the effects of Mindfulness training in adults with ADHD on ADHD
symptoms and comorbidity with affective and anxiety symptoms. Also, the
feasibility of Mindfulness training will be evaluated in this specific
patientgroup and the effect on the quality of life.
Study design
It is a controlled, randomised study in which 96 patients who have given
written informed consent, are randomised in either mindfulness training(n=48),
or the waitinglist control group (n=48).
The trainingprogram includes 12 weekly sessions in a group of 12 participants
and 2 4 weekly sessions. The primary and secondary outcome measures will be
taken at the beginning (week 0), in the end (week 20) . Attention tasks will be
measured by neuropsychological test. A follow-up measure will take place 2
months after the end of the study for the Mindfulness traininggroup.
Intervention
Training program is conform Mindfulness Based Cognitive Therapy protocol which
is used to prevent a relapse in depressive disorder and developed by Teasdale,
Williams and Seagal.
This program is adjusted for the ADHD patientgroup and includes 12 weekly
sessions with the duration of 2,5 hours per sessionand 2 4 weekly sessions
instead of 8 sessions of 2,5 hours per session and involves educative
information about ADHD.
Study burden and risks
Mindfulness traininggroup:
Time investment: 7,5 hours (3x2,5 hours) for CAARS-Investigator Rated
Interview, to administer study instruments and neuropsychological test (ANT)
and Electroencephalogram
35 hours for participation on the sessions (14x2,5 hours) in 20 weeks during
the study
60 hours of practicing Mindfulness skills
Total: 102,5 hours
Waitinglistgroup:
Time investment: 5 hours (2x2,5 hours) for CAARS-Investigator Rated Interview,
to administer study instruments and neuropsychological test (ANT) and
Electroencephalogram
Total: 5 hours
Reinier Postlaan 10
6500 HB Nijmegen
NL
Reinier Postlaan 10
6500 HB Nijmegen
NL
Listed location countries
Age
Inclusion criteria
patients 18 years of age or older,
diagnosed with ADHD (meets DSM IV criteria for one or other subtype of ADHD)
Capable of speaking and writing in Dutch
Exclusion criteria
substance abuse/dependence within the past 6 months,
a history of psychotic illness, bipolar I disorder, mental retardation, severe borderline or antisocial personality disorder, conduct disorder and chronic suicidal or self-injurious behavior.
Design
Recruitment
Medical products/devices used
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 | NL25843.091.09 |