Computer Enabled Neuroplasticity Treatment (CENT)
| ISRCTN | ISRCTN13915109 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13915109 |
| Secondary identifying numbers | 440078 |
- Submission date
- 19/07/2015
- Registration date
- 22/09/2015
- Last edited
- 10/10/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
Attention deficit hyperactivity disorder (ADHD) is a neurobiological condition (that is, a condition affecting the nervous system caused by a biological factor, for example genetics) that results in a number of behavioural symptoms including a short attention span, restlessness and acting on impulse. It can also cause sleeping problems and anxiety. The condition is most often seen in people with learning difficulties but can affect people of any intellectual ability. It can have a considerable effect on several areas of a sufferers life, leading to a relatively poor economic and social position within their population (lower socioeconomic status), less satisfaction with their employment and marriage and conditions such as depression and addiction. It is thought that 4.4% of adults have ADHD. However the nature of the disease and the best way to treat it are still not well understood; it is thought that the efficacy of pharmacological and/or therapeutic treatments is adversely affected by people refusing or not persisting with the treatment and has not been shown to last beyond 2 years. The aim of this study is to see whether neurofeedback (NFB) will result in better treatment outcomes for adults with ADHD.
Who can participate?
Adults diagnosed with ADHD and with a IQ score of more than 80.
What does the study involve?
Participants are randomly assigned to one of two groups. Those in group 1 (intervention group) are given 40 one-hour sessions of neurofeedback. Those in group 2 (waitlist group) also receive the sessions but only after the study is complete. All participants are asked to report on their own ADHD symptoms at the start of the study, one year after treatment and then 2.5 years after treatment. Attention span is also measured, using a computer test, at the beginning of the study and after treatment.
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
Mental Capital Care clinic, Helsinki (Finland)
When is the study starting and how long is it expected to run for?
October 2011 to June 2016
Who is funding the study?
Finnish Funding Agency for Innovation (Tekes)
Who is the main contact?
Dr Ben Cowley
ben.cowley@helsinki.fi
Contact information
Scientific
Työterveyslaitos
PL 40
Helsinki
00251
Finland
 ORCID ID |
0000-0001-8828-2994 |
|---|
Study information
| Study design | Randomized controlled single-centre trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Clinical trial of neurofeedback therapy intervention for finnish adult ADHD, with waiting list control and comparison of outcomes of pre- to post-treatment improvement on self-reported symptoms and computerised attention tests |
| Study acronym | CENT |
| Study objectives | Attention Deficit/Hyperactivity Disorder (ADHD) is a common psychiatric disorder, with an estimated worldwide prevalence among children of around 5% (Polanczyc et al., 2007), and persistence into adolescence and adulthood estimated between 40-60% (Faraone et al., 2006); it is associated with a variety of problems such as poor socialization and academic performance, and the efficacy of pharmacological and/or therapeutic treatments is adversely affected by non-compliance or aversion and has not been shown to last beyond 2 years. Principal hypothesis: application of neurofeedback will result in improved scores on self-report measures of ADHD, and computerised attention tests, compared to waiting list control. |
| Ethics approval(s) | Helsingin ja Uudenmaan Sairaanhoitopiiri (english: Hospital District of Helsinki and Uusimaa), 28/03/2012, JulkL 621/1999, 24 § |
| Health condition(s) or problem(s) studied | Attention Deficit/Hyperactivity Disorder (ADHD) |
| Intervention | After randomisation, the treatment group will be given 40 sessions of 1 hour per session of neurofeedback at the Mental Capital Care clinic in Helsinki. Baseline, post-treatment and follow-up measurements as described. The control group will be tested at the same times as the treatment group. They will receive a computerised attention training intervention after the follow-up measurement. |
| Intervention type | Behavioural |
| Primary outcome measure | 1. Self-report of ADHD symptoms, using Brown Attention Deficit Disorder Scale (BADDS) to be measured at baseline, post-treatment 1 year after baseline, and follow-up 2.5 years after treatment 2. Adult ADHD Self Report Scale (ASRS) to be measured at the same timepoints as BADDS 3. Objective measure of attention, using the computerised Test Of Variables of Attention (TOVA), to be completed at baseline and post-treatment |
| Secondary outcome measures | Treatment group records of performance during neurofeedback ('learning curves'). |
| Overall study start date | 01/10/2011 |
| Completion date | 01/06/2016 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 55 |
| Total final enrolment | 54 |
| Key inclusion criteria | 1. Pre-existing diagnosis of ADHD 2. Nonexistence of neurological diagnoses 3. IQ score > 80 measured by a qualified psychologist using WAIS IV 4. Scores on ASRS and BADDS indicating presence of ADHD |
| Key exclusion criteria | Extreme outlier scores in the scales of 1. Generalized Anxiety Disorder (Spitzer et al., 2006) 2. Beck Depression Inventory (Beck et al., 1996) 3. Alcohol Use Disorders Identification Test (Saunders et al., 1993) 4. The Mood Disorder Questionnaire (Robert et al., 2000) 5. Test of prodromal symptoms of psychosis (Heinimaa et al., 2003) 6. Dissociative experiences scale (Liebowitz, 1992) for dissociative symptoms Thresholds for exclusion were not fixed but at the discretion of the consulting psychiatrist. Use of medication for ADHD was not an exclusion criterion but participants were asked not to make changes in medication during the time of the training. |
| Date of first enrolment | 01/04/2012 |
| Date of final enrolment | 01/08/2012 |
Locations
Countries of recruitment
- Finland
Study participating centre
Helsinki
00700
Finland
Sponsor information
University/education
Institute of Behavioural Sciences
PO Box 9
Helsinki
FI-00014
Finland
| Phone | +358 (0)294 1911 |
|---|---|
| ibs-info@helsinki.fi | |
| Website | http://www.helsinki.fi/ibs/index.htm |
"ROR" |
https://ror.org/040af2s02 |
Funders
Funder type
Government
Government organisation / Local government
- Alternative name(s)
- Finnish Funding Agency for Innovation
- Location
- Finland
Results and Publications
| Intention to publish date | 01/01/2016 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | A journal publication is planned, titled: Learning and Arousal: a Clinical Trial Report on a Novel Neurofeedback Design for Adult ADHD A Master's thesis was completed describing some results of the initial treatment phase, titled: A neurofeedback intervention study on adults with ADHD by Edua Hölmström Further publications are to be confirmed. |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 09/05/2016 | Yes | No | |
| Other publications | 29/06/2021 | 10/10/2023 | Yes | No |
Editorial Notes
10/10/2023: Publication reference and total final enrolment added.
01/06/2016: Publication reference added.
