Plain English Summary
Background and study aims
Individuals with attention deficit hyperactivity disorder (ADHD) often face problems in executive functions, including visuospatial and verbal working memory. Cognitive training has been proposed as a candidate for ADHD rehabilitation, and previous studies have shown it can have positive effects on untrained working memory tasks and even on inhibition control and attention. It is less clear how cognitive training affects brain activity or structure in individuals with ADHD. This study aims to explore how working memory training affects the brain’s white matter structures and brain activation during working memory performance, rest, and movie watching in individuals with ADHD.
Who can participate?
Participants aged 18 to 63 years with ADHD
What does the study involve?
Adults with ADHD took part in a randomised controlled working memory trial, either training on a dual n-back working memory task or, as an active control, playing the Bejeweled 2 computer game. Participants in both groups trained for 5 weeks, thrice a week, for 25 minutes at a time. Neuropsychological assessment, other cognitive tasks, and functional and MRI scans were conducted before and after the training period.
What are the possible benefits and risks of participating?
Magnetic resonance imaging is a safe, non-invasive method, and due to careful pre-screening no harms were expected or experienced. Working memory training might in general have positive effects on ADHD symptoms and working memory deficits.
Where is the study run from?
1. Åbo Akademi University (Finland)
2. University of Helsinki (Finland)
3. Hospital District of Helsinki and Uusimaa (Finland)
When is the study starting and how long is it expected to run for?
January 2015 to February 2018
Who is funding the study?
1. Åbo Akademi University (Finland)
2. Research Council of Finland
Who is the main contact?
Tuija Tolonen, tuija.tolonen@helsinki.fi
Study website
Contact information
Type
Principal Investigator
Contact name
Prof Matti Laine
ORCID ID
Contact details
Tehtaankatu 2
Turku
20500
Finland
N/A
matti.laine@abo.fi
Type
Scientific
Contact name
Dr Juha Salmitaival
ORCID ID
Contact details
Otakaari 3
Espoo
02150
Finland
N/A
juha.salmitaival@aalto.fi
Type
Public
Contact name
Ms Tuija Tolonen
ORCID ID
Contact details
Haartmaninkatu 3
Helsinki
00290
Finland
N/A
tuija.tolonen@helsinki.fi
Additional identifiers
EudraCT/CTIS number
Nil known
IRAS number
ClinicalTrials.gov number
Nil known
Protocol/serial number
Nil known
Study information
Scientific title
A randomised controlled trial to examine the effects of computerised working memory training on brain activity and structural and functional connectivity in adults with attention deficit hyperactivity disorder
Acronym
ADHD-Train
Study hypothesis
Due to its exploratory nature, this study is based on study questions, rather than hypotheses:
1. Does working memory training affect regional brain activation during working memory performance, rest, or movie watching?
2. Does working memory training affect temporal brain activity correlations between brain areas during working memory performance, rest, or movie watching?
3. Does working memory training affect white matter microstructure or connectivity?
Ethics approval(s)
Approved 30/06/2015, Ethics Committee for Gynecology and Obstetrics, Pediatrics and Psychiatry of the Helsinki and Uusimaa Hospital District (Tukholmankatu 8 C, Helsinki, 00290, Finland; +358 (0)40 359 4618; eettiset.toimikunnat@hus.fi), ref: HUS/1166/2021
Study design
Double-blind randomized controlled single-center study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Home, Laboratory, University/medical school/dental school
Study type
Treatment
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Condition
Attention deficit hyperactivity disorder
Intervention
After a pretest including neuropsychological assignment, cognitive tasks, and magnetic resonance imaging, the participants were assigned to an experimental group (performing dual n-back working memory task) or an active control group (playing Bejeweled 2 computer game) with simple randomisation using an equal amount of lottery tickets per group. Each participant in both groups trained for 5 weeks, three times a week, 25 minutes at a time, adding up to total of 15 training sessions. A post-test with the same elements as the pretest was conducted after the cognitive training. The participants were blind to whether they belonged to the experimental or the control group, as was the experimenter conducting the pre- and post-tests.
Intervention type
Behavioural
Primary outcome measure
Blood oxygen level dependent (BOLD) signal in the brain measured by functional magnetic resonance imaging during the pretest (within few weeks before the cognitive training) and the posttest (within few weeks after the cognitive training). Due to the study’s experimental design, BOLD signal is assessed in different conditions (during working memory task, rest, and movie watching) and can be analysed in several ways, including regional activity and their temporal correlations.
Secondary outcome measures
White matter properties of the brain measured by diffusion-weighted magnetic resonance imaging during the pretest (within a few weeks before the cognitive training) and the posttest (within a few weeks after the cognitive training). White matter properties can be analysed in several ways, including microstructure and tractography.
Overall study start date
01/01/2015
Overall study end date
28/02/2018
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Age between 18 and 63 years
2. Diagnosed with attention deficit hyperactivity disorder according to DSM-IV by a specialised doctor
3. Excellent competency in Finnish
4. Sufficient vision and hearing
Participant type(s)
Patient
Age group
Adult
Lower age limit
18 Years
Upper age limit
63 Years
Sex
Both
Target number of participants
60
Total final enrolment
44
Participant exclusion criteria
1. History of brain damage
2. Other severe neurological or psychiatric disorders apart from ADHD, including substance abuse or other addictions
3. IQ lower than 70 assessed by the Wechsler Adult Intelligence Scale III
4. Magnetic resonance imaging contraindications
Recruitment start date
01/08/2015
Recruitment end date
31/01/2018
Locations
Countries of recruitment
Finland
Study participating centre
Institute of Behavioural Sciences, University of Helsinki
Siltavuorenpenger 5
Helsinki
00170
Finland
Study participating centre
Advanced Magnetic Imaging Centre, Aalto University
Otakaari 5
Espoo
02150
Finland
Sponsor information
Organisation
Åbo Akademi University
Sponsor details
Tuomiokirkontori 3
Turku
20500
Finland
+358 (0)221531
fhpt@abo.fi
Sponsor type
University/education
Website
ROR
Funders
Funder type
University/education
Funder name
Åbo Akademi
Alternative name(s)
ÅA
Funding Body Type
government organisation
Funding Body Subtype
Local government
Location
Finland
Funder name
Research Council of Finland
Alternative name(s)
Suomen Akatemia, Finlands Akademi, Academy of Finland, AKA
Funding Body Type
government organisation
Funding Body Subtype
Universities (academic only)
Location
Finland
Results and Publications
Publication and dissemination plan
One study of this trial has already been published in Human Brain Mapping (https://pubmed.ncbi.nlm.nih.gov/32813290/). Future studies will be published in high-impact peer-reviewed journals.
Intention to publish date
19/08/2020
Individual participant data (IPD) sharing plan
The datasets generated during and/or analysed during the current study are not expected to be made available due to the details in the ethical agreement for the study.
IPD sharing plan summary
Not expected to be made available
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
---|---|---|---|---|---|
Results article | 19/08/2020 | 07/05/2024 | Yes | No |